Clinical outcomes of asynchronous telerehabilitation through a mobile app are equivalent to synchronous telerehabilitation in patients with fibromyalgia: a randomized control study

Abstract

Background

This study aimed to compare the effectiveness of exercise therapy delivered via a smartphone mobile app, using asynchronous video-based tools, with synchronous telerehabilitation models using videoconferencing for individuals with fibromyalgia syndrome (FMS).

Methods

The research, utilizing a randomized clinical study design, involves sixty-six FMS patients in an 8-week exercise program. Participants are divided into synchronous (n: 33) and asynchronous (n: 33) groups. Assessments, pain intensity (VAS), functional limitations (FIQr), health-related quality of life (SF 12), catastrophizing (PCS), anxiety and depression (HADS), functional capacity (6MWT), muscle strength (Arm curl test), and joint position sense (LI-RATT), are conducted at baseline, mid-treatment (week 4), end of treatment (week 8).

Results

No significant group-time interaction was found for total VAS, FIQ, SF 12, PCS, HADS, 6MWT, Arm curl tests, LI-RATT extension, LI-RATT flexion, LI-RATT right rotation scores (p > 0.05). Significant effects of time and interactions between groups and time were observed in the neck (p = 0.010, ES = 0.19) and back region (p = 0.039, ES = 0.19) of the Visual Analog Scale, left rotation score of the LI-RATT (p = 0.008, ES = 0.36), and HADS Anxiety Score (p = 0.029, ES = 0.31). Group differences were significant at all-time points for the outcomes (p < 0.001), except for the right rotation of LI-RATT (p = 0.633).

Conclusion

The study suggests that asynchronous telerehabilitation is comparable to synchronous methods in addressing pain, quality of life, and other factors in FMS patients. The asynchronous approach may offer advantages in reducing the burden on healthcare professionals and being cost-effective. Future research should explore diverse telerehabilitation protocols and their impact on overall care burdens.

Trial registration

NCT06299527 (01/03/2024).

Introduction

Fibromyalgia syndrome (FMS) is characterized by chronic, widespread pain, fatigue, poor sleep, and altered cognitive problems and affects between 2 and 4% of all populations worldwide [1]. The symptoms of FMS significantly impact economic repercussions that affect health-related quality of life and may cause problems in daily activities [2]. Patient education and non-pharmacological interventions are essential in treating FMS, and among the treatments specified, clinical guidelines include various physiotherapeutic interventions necessary for individuals affected [3].

Common conservative physiotherapy modalities for treating fibromyalgia are exercise therapy, mind–body therapies, health education, and integrative and complementary therapies [4]. Access to conservative physiotherapy is often hindered by various barriers, including travel restrictions, lack of clinicians and healthcare facilities, geographic constraints, and high personal care costs [5]. Telerehabilitation, a subset of telemedicine that has become widespread with the Covid 19 epidemic, is one of the new treatment perspectives recently implemented to overcome these challenges and aims to facilitate and improve access to and treatment adherence [6].

Interest in telerehabilitation has grown and developed over the last decade, forming the structure of the remote rehabilitation offer [7]. Existing studies have implemented different telerehabilitation models, and the literature reveals non-inferior results compared to standard care [7, 8].

Synchronous telerehabilitation, the most frequently used method, employing real-time video conferencing, has demonstrated favorable outcomes for individuals with fibromyalgia and related musculoskeletal conditions [9]. Nevertheless, challenges emerge in the form of the necessity for simultaneous availability of patients and clinicians, coupled with potential technical obstacles, notably, high-speed internet connectivity (requiring access to a high-quality screen and a reliable connection) and computer accessibility. These challenges can impede the seamless implementation of synchronous rehabilitation [10]. In contrast, mobile-based asynchronous visual platforms, which utilize short videos or images for information exchange without the need for simultaneous access, seek to alleviate these concerns, offering an attractive alternative to synchronous telerehabilitation [10,11,12]. In the future, the key lies in selecting the most suitable model for individual patients to enhance the cost-effectiveness of telerehabilitation interventions [13]. An uncomplicated method, such as asynchronous telerehabilitation with minimal device requirements, may be effective for some patients. However, a more complex approach that includes real-time exercise and monitoring becomes essential to ensure the safe execution of remote exercises for individuals with fibromyalgia.

Nevertheless, studies comparing synchronous and asynchronous telerehabilitation methods are needed. Additionally, more published reports need to document the utilization of an asynchronous platform for the telerehabilitation of individuals with fibromyalgia. Therefore, this study aimed to compare exercise therapy delivered through an asynchronous video-based tool with synchronous telerehabilitation models for individuals with FMS.

Methods

Study design

The intervention was described following the TIDieR (Template for Intervention Description and Replication) Checklist to ensure comprehensive reporting, and the completed checklist is included as a supplementary file.

This randomized controlled study was conducted to investigate the effects of telerehabilitation on pain, quality of life, functional capacity, muscle strength, joint position sense, anxiety and depression in individuals diagnosed with fibromyalgia who applied to Marmara University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation. The study was approved by the Marmara University Faculty of Medicine Clinical Studies Ethics Committee (Approval Number: 76) and was conducted in accordance with the Declaration of Helsinki [clinical trial registry number NCT06299527 (01/03/2024)]. The participants were informed about the study, and informed consent was obtained.

Participants

The study included participants aged 18–65 diagnosed with Fibromyalgia Syndrome (FMS) by a physician according to the American College of Rheumatology (ACR) 2016 criteria. Participants needed to be independently mobile, have minimal vision and hearing loss, possess basic literacy skills, and voluntarily agree to participate. Additionally, they required the ability to make video calls and possess internet and smartphone access.

Individuals with a rheumatic disease causing more significant symptoms than FMS, active infections, surgeries within the past three months, uncontrolled chronic illnesses, other musculoskeletal disorders impacting functional capacity, advanced osteoporosis, or who had received physiotherapy or rehabilitation in the last 6 months were excluded.

The sample size was calculated using G-POWER software for the primary outcome measure, the Numerical Pain Rating Scale (NPRS), with an effect size of 0.4, power of 95%, and alpha level of 0.05. The required sample size was 54 participants (27 per group). Considering a potential 10% dropout, we initially recruited 60 participants.

Participants were randomized into synchronous and asynchronous telerehabilitation groups using 1:1 stratified sampling based on age and sex to achieve balance in these characteristics. While this method aimed to ensure comparable group distributions, slight variations were observed, with the asynchronous group comprising 17 women and 16 men, and the synchronous group comprising 21 women and 12 men. These differences are consistent with expected variability in small sample stratified randomization. Intention-to-Treat (ITT) analysis was applied to ensure that all participants remained in their originally assigned groups for the final analysis, thereby preserving group comparability and minimizing potential bias.

Outcome measures

A blinded physiotherapist administered outcome measures, which included information from the demographic data form, pain level assessed using the Visual Analog Scale, functional limitations and disabilities measured by the Revised Fibromyalgia Impact Questionnaire, quality of life evaluated with the Short Form-12 scale, and psychological factors assessed using the Pain Catastrophizing Scale, Hospital Anxiety and Depression Scale. Functional capacities were measured using the 6 Minute Walk Test, upper body functional strength with the arm flexion test, and Laser Cursor Assisted Angle Repetition test to evaluate cervical joint position sense and proprioception.

A total of four assessments were performed before treatment, at mid-treatment (week 4), at the end of treatment (week 8) for follow-up.

Demographic Information: Gender, age, height, body weight, education level, occupation and, activity levels of the patients were questioned and recorded. The researcher who performed the assessments interviewed the patients face-to-face and applied the data collection tools.

A visual analog scale (VAS) was used to evaluate the patient's pain. This scale is used to quantify pain intensity that cannot be measured numerically. Numbers are written on the two ends of a 10 cm line. The patient is asked to indicate on this line where the pain condition is appropriate during rest by drawing a line, putting a dot or pointing. For pain intensity, according to the scale, "no pain" will be rated as 0 points and "worst pain imaginable" as 10 points. The validity and reliability of the test were developed by Clarke et al. [14]. The test has proven itself for a long time and has been accepted in world literature [15]. It is reliable and easy to administer.

The Revised Fibromyalgia Impact Questionnaire (FIQr) was used to assess limitations and functional disability in FMS patients. The patient was asked to complete the questionnaire consisting of three sections and 21 questions. This scale measures 10 characteristics: physical function, well-being, inability to go to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. All questions are assessed on a numeric scale of 0–10. The Fibromyalgia Impact Questionnaire (FIQ) was developed by members of the fibromyalgia treatment team at Oregon Health and Science University [16]. It was first used to analyze the Oregon multidisciplinary approach to fibromyalgia treatment [17]. The FIQr was developed by Bennett et al. in 2009 [17]. The questionnaire was divided into sections, and the question contents were arranged in a more detailed way for fibromyalgia symptoms. Turkish validity and reliability study was conducted by Ediz et al. [18].

The Pain Catastrophizing Scale (PCS) was used to assess the extent of patients' destructive thoughts and feelings associated with the sensation of pain. It is a 13-item questionnaire to be completed by the patient. It consists of three subscales: helplessness, exaggerated perception and rumination. Each item is scored on a 5-point scale, with higher values indicating greater destructiveness. The sum of the corresponding items gives scores for the subscales; the total score is calculated by summing all items. PCS scores range from 0 to 52 points. The Pain Catastrophizing Scale was developed by Sullivan et al. in 1995 [19]. Turkish validity and reliability was performed by Süren et al. [20].

The Hospital Anxiety and Depression Scale (HADS) was used to determine the anxiety and depression status of the patients. It includes anxiety and depression subscales. The scale is a self-report scale and consists of a total of 14 items, 7 of which investigate symptoms of depression and 7 of which investigate symptoms of anxiety. Responses are evaluated on a four-point Likert scale and scored on a 0–3 scale. In preparing the scoring, 0–1 will be considered as not ill, 2 as borderline ill, and 3–4 as significantly ill. Zigmond and Snaith developed the HADS Scale, and its validity and reliability were established [21]. Its Turkish validity and reliability was conducted by Aydemir et al. in 1997 [22].

The 6-min walk test (6MWT) was used to measure the functional capacity of the patients. 6MWT is a submaximal, indirect cardiovascular physical fitness test. It was developed by Balke in 1963 to measure functional capacity [23]. The test will be performed on a 30 m-long flat walking track with a marked start and end point. On this track, the participant should walk for 6 min, making rounds and turns. There should not be any obstacles or crowds on the track. The ground should be flat and hard. The participant determines the walking speed himself/herself. He/she performs the test at the most suitable speed for him/her. The patient can rest during that time. The stopwatch was not stopped during the rest period; the participant's rest will be noted, and the rest period will be recorded. If test termination criteria are met, the test will be terminated. Emergency intervention was applied if necessary. The test was terminated after 6 min. The distance recorded at the end of the 6MWT was compared with the reference value obtained from the estimation equations using the participant's gender, age, height and body mass index [24].

Arm Curl Test: The Arm curl test was used to assess the upper trunk functional strength of the patients. A straight-back chair without armrests, a stopwatch and a small hand barbell were used. The patient sits slightly on the edge of the chair towards the side of the arm to be tested and completes the test by making full lifts for 30 s with the arm in full extension below and full flexion above. The test starts with the patient's arm in extension and perpendicular to the floor. Before starting the test, the patient is shown and explained how the test will be performed and is made to try 2–3 times without giving the weights. After ensuring that the patient understands how to perform the test, the test is started, and the number of full weight lifts during 30 s constitutes the patient's score [25].

Laser Cursor Assisted Angle Repetition Test (LI-RATT): This test was used as a Repetition test to evaluate the cervical joint position sense of the patients. With the test, joint position sense, which is a part of proprioception and provides information about the speed and direction of active and passive movements of individuals without visual stimulation, will be measured. The protocol described by Revel et al. was used to apply the test [26]. Patients were positioned 90 cm between the target table, which is 90 × 80 cm, and the person. The laser pointer was placed around the head with the help of a suitable tape in the center of the forehead of the individual. The patient's head was positioned so the laser pointer pointed vertically to the center of the target table. All test steps were taught first, with the eyes open. Patients were asked to aim the laser at the center point (origin) of the target table with their eyes open at the starting position. They were then asked to close their eyes and flex their head. They were then asked to maintain the eyes closed position, bring their head to neutral and target the midpoint with the laser. While bringing the head back to neutral, they are asked to stand where they feel they have reached the midpoint and the distance from this point to the starting position is measured. The test was repeated 3 times. Active neck movements (extension, flexion, right and left rotation) will be evaluated. Calculations will be made by measuring the distance (error distance) between the starting and the last point reached on the target table and dividing this value by 90 cm. [Grade = Tan- 1 (Error Distance/90 cm)] [26].

Short Form—12: Short Form—12 was used to assess patients' health related quality of life (HrQoL). The Short Form-36 was developed by Ware et al. to assess HrQoL [27]. This scale, comprising thirty-six items, addresses the dimensions of physical functioning, role limitation due to physical problems, pain, social functioning, mental health, role limitation due to emotional state, energy and a general understanding of health. The subscales assess health between 0 and 100. Similar to the Short Form-36, the Short Form-12 consists of 8 subscales and 12 items, including physical functioning (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social functioning (1 item), emotional role (2 items) and mental health (2 items) [27, 28]. Each sub-dimension of each scale is calculated with the help of a formula, and the scores are between 0 and 100. Moreover, at the same time, a high score indicates good quality of life [29].

Interventions

Exercise program

This study employed a mobile application or video conferencing to deliver a personalized exercise program. Following an initial face-to-face assessment by a blinded assessor, participants engaged in an individual session to establish an exercise program aligned with the American Pain Society guidelines for fibromyalgia [30].

Both groups received same program encompassing aerobic, strength training, balance, and flexibility exercises performed three times per week. The program duration was 3 days a week, 1 session per day, for 8 weeks, with sessions progressing from 30 min to one hour.

This program employed the Modified Borg Scale (a validated tool for perceived exertion in FMS patients [31, 32] to individually adjust exercise intensity during each session. Participants reported their exertion level from the previous session, with intensity increasing if the score was below 4 and decreasing if it exceeded 7, following the protocol established by Duruturk et al. [33].

To ensure safety and prevent adverse events, the program incorporated a cool-down phase consisting of static stretches held for 30 s each across major muscle groups, combined with guided breathing exercises. The physiotherapist delivering the intervention monitored and adapted all exercises throughout the program. Treatment adherence was monitored through an online attendance record system accessible by both mobile application and videoconference groups.

Asynchronous group:

The asynchronous telerehabilitation program was delivered through the FizyoTr mobile application, an advanced platform developed by the research team at Marmara University’s Physiotherapy and Rehabilitation Department. This platform was designed specifically for the needs of the different patient population and was compatible with both Android and iOS devices. The app development involved two stages: initially, exercise videos and program-specific content were created and securely uploaded to data servers; subsequently, mobile, smartwatch, and web applications were developed, enabling participants to access resources on their preferred devices [11, 34, 35].

Each participant in the asynchronous group was given a personalized account within the FizyoTr app, where they could view their individualized exercise program. This program included instructional videos alongside detailed written and verbal instructions, allowing participants to complete exercises independently at home. To facilitate accessibility, participants could download the app directly from the Google Play or Apple Store, and their personalized exercise plans were automatically synced to their account.

The sessions were structured to last between 30 min to 1 h, with the duration and intensity of exercises gradually progressing based on each participant's reported exertion levels, monitored through the Modified Borg Scale. This progression ensured that the sessions remained challenging yet manageable, adapting to each participant’s capabilities and fitness level. Participants were encouraged to complete their exercises three times per week, with each session incorporating aerobic, strength, balance, and flexibility exercises. The exercise program was updated weekly by the supervising therapist based on individual progress and feedback, with parameters such as frequency, intensity, and specific exercises tailored to each participant’s needs.

The app’s progress tracking feature allowed both participants and therapists to monitor exercise completion on a daily, weekly, and monthly basis, providing visual feedback to encourage consistent participation. For additional safety and privacy, all data within the app was securely stored on encrypted servers and transmitted over a secure connection, allowing therapists to review attendance records and reach out to participants as needed.

Synchronous Group:

Participants in the synchronous group attended live, supervised exercise sessions via videoconferencing, led by a researcher. These sessions were also scheduled three times per week, with each session lasting between 30 min and 1 h, allowing for warm-up, aerobic exercise, strength training, balance activities, and cool-down stretches. The session content and progression were identical to the asynchronous group; however, real-time supervision allowed for immediate guidance and feedback. Participants were grouped by similar functional levels, with each session accommodating five participants to facilitate personalized interaction while maintaining a standardized approach across sessions. The researcher monitored participants’ exertion levels using the Modified Borg Scale during each session, adjusting intensity as needed to align with participants' capabilities and goals [11, 34, 35].

The flow diagram of the study is presented in Figure 1.

Fig. 1

Participant flow

Data analysis

SPSS 20.0 (Statistical Package for the Social Sciences) was used for statistical analysis. The normal distribution of the data was tested using the One-Sample Kolmogorov–Smirnov test and histogram evaluations. Descriptive analyses were presented as means and standard deviations, medians and quartile ranges, or frequencies, depending on data type and distribution.

Repeated measures ANOVA was employed to assess the effects of time and group factors on the outcomes and their interactions. Cohen's d was used to measure effect size in the repeated measures ANOVA analysis, with values interpreted as small (0.2), medium (0.5), or large (0.8), based on the standard deviations of the mean differences between groups [36]. The post-hoc analysis conducted for parameters with significant differences showed that changes over time varied between the asynchronous and synchronous groups across specific measures.

It has been reported that the minimally clinically important difference (MCID) to detect a meaningful change in pain on a Visual Analog Scale (VAS) for fibromyalgia patients is 1.37 cm on a 10 cm line [37]. Accordingly, an MCID analysis was conducted to evaluate whether the observed changes in VAS scores met this threshold, allowing for a clearer assessment of clinically significant pain reduction.

Results

A total of 66 participants were randomly assigned to either asynchronous (17 women and 16 men) or synchronous (21 women and 12 men) telerehabilitation group. Table 1 shows the characteristics of the participants.

Table 1 Demographic and clinical characteristics of participants by groups

Pain-related outcomes

The analysis revealed no significant interaction between group and time for total VAS scores (P = 0.144) or regional VAS scores for shoulder (P = 0.437), arm (P = 0.378), waist (P = 0.153), hip (P = 0.228), and knee (P = 0.813). However, a significant interaction was found for VAS Neck (P = 0.010, ES = 0.19) and VAS Back (P = 0.039, ES = 0.19), indicating differences between the asynchronous and synchronous groups over time. A significant main effect of time was observed for all pain outcomes (P < 0.001), demonstrating overall improvements in pain levels across both groups (Table 2).

Table 2 Pain related outcomes at each time point and results of repeated measures ANOVA

Post-hoc analyses for VAS Neck and VAS Back revealed significant differences favoring the synchronous group at both the 4th and 8th weeks (P < 0.05), indicating a greater reduction in neck and back pain within the synchronous group. Effect sizes (ES = 0.19) for these outcomes suggest small but clinically meaningful differences in pain reduction.

Minimal Clinically Important Difference (MCID) analysis

MCID was defined as a threshold of 1.37 cm on the 10 cm VAS scale. Changes in pain scores from baseline to 8 weeks were evaluated for clinical significance:

VAS neck

The baseline intensity was moderate in both groups (5.90 ± 2.41 in the asynchronous group and 6.39 ± 1.90 in the synchronous group). Over 8 weeks, the asynchronous group demonstrated a 3 cm reduction (5.90 to 2.90), improving from moderate to mild pain intensity. Similarly, the synchronous group showed a 3.1 cm reduction (6.39 to 3.38), which remained within the moderate intensity range. These changes were statistically significant (P = 0.010) and clinically meaningful based on the MCID threshold for FMS patients. Within the first 4 weeks, 48.48% of participants in the asynchronous group and 66.67% in the synchronous group achieved clinically significant improvements.

VAS back

Both groups demonstrated clinically meaningful reductions in back pain from baseline to 8 weeks, with a 3.22 cm reduction (5.97 to 2.75) in the asynchronous group and a 3.28 cm reduction (6.48 to 3.20) in the synchronous group. These reductions were statistically significant (P = 0.039) and exceeded the MCID threshold. Over the period, 57.58% of participants in the asynchronous group and 69.70% in the synchronous group achieved MCID.

VAS shoulder

Baseline scores were 4.54 ± 2.51 in the asynchronous group and 5.06 ± 2.20 in the synchronous group. Over 8 weeks, the asynchronous group demonstrated a 2.72 cm reduction (4.54 to 1.82), and the synchronous group showed a 2.19 cm reduction (5.06 to 2.87). Both changes were clinically meaningful but not statistically different between groups (P = 0.437). These results suggest that both interventions were effective in reducing shoulder pain. By 4 weeks, 39.39% in the asynchronous group and 48.48% in the synchronous group achieved MCID, with slightly lower percentages (27.27% and 21.21%, respectively) from 4 to 8 weeks.

VAS arm

Baseline scores for arm pain were 3.15 ± 2.26 in the asynchronous group and 3.81 ± 2.76 in the synchronous group. Over 8 weeks, the asynchronous group demonstrated a 2.20 cm reduction (3.15 to 0.95), while the synchronous group showed a 1.83 cm reduction (3.81 to 1.98). Although these changes exceeded the MCID threshold, they were not statistically different between groups (P = 0.378), highlighting comparable effectiveness of both interventions in managing arm pain. From baseline to 4 weeks, 27.27% in the asynchronous group and 36.36% in the synchronous group achieved MCID, with fewer participants meeting this criterion from 4 to 8 weeks (18.18% and 15.15%, respectively).

VAS waist

Baseline scores for waist pain were 5.48 ± 2.78 in the asynchronous group and 5.84 ± 1.97 in the synchronous group. Over 8 weeks, the asynchronous group demonstrated a 3.29 cm reduction (5.48 to 2.19), while the synchronous group showed a 3.14 cm reduction (5.84 to 2.70). Both reductions were clinically meaningful but not statistically different between groups (P = 0.153). From baseline to 4 weeks, 48.48% of participants in the asynchronous group and 51.52% in the synchronous group achieved MCID, with fewer participants meeting this criterion from 4 to 8 weeks (30.30% and 27.27%, respectively).

VAS hip

Baseline scores for hip pain were 4.33 ± 2.41 in the asynchronous group and 4.36 ± 3.15 in the synchronous group. Over 8 weeks, the asynchronous group demonstrated a 2.55 cm reduction (4.33 to 1.78), and the synchronous group showed a 2.19 cm reduction (4.36 to 2.17). Both reductions exceeded the MCID threshold but were not statistically different between groups (P = 0.228). By 4 weeks, 24.24% of participants in the asynchronous group and 33.33% in the synchronous group achieved MCID, with similar percentages observed from 4 to 8 weeks (24.24% and 21.21%, respectively).

VAS knee

Baseline scores for knee pain were 4.36 ± 2.19 in the asynchronous group and 4.51 ± 2.39 in the synchronous group. Over 8 weeks, the asynchronous group demonstrated a 1.73 cm reduction (4.36 to 2.63), while the synchronous group showed a 2.00 cm reduction (4.51 to 2.51). Although these reductions exceeded the MCID threshold, they were not statistically different between groups (P = 0.813). Both interventions effectively managed knee pain with comparable outcomes. Baseline scores for knee pain were 4.36 ± 2.19 in the asynchronous group and 4.51 ± 2.39 in the synchronous group. From baseline to 4 weeks, 30.30% of participants in the asynchronous group and 24.24% in the synchronous group achieved MCID, with slightly lower percentages observed from 4 to 8 weeks (27.27% and 21.21%, respectively).

Functional capacity outcomes

No significant interaction between group and time was observed for any functional capacity outcomes (P > 0.05), except for LI-RATT Left Rotation (P = 0.008, ES = 0.36). Post-hoc analysis revealed that the synchronous group demonstrated significantly greater improvement in left rotation scores by the 8th week (P < 0.05). A significant main effect of time was found for all functional capacity outcomes (P < 0.001), except for LI-RATT Right Rotation (P = 0.633). The moderate effect size (ES = 0.36) for left rotation suggests meaningful improvements in functional capacity (Table 3).

Table 3 Functional capacity outcomes at each time point and results of repeated measures ANOVA

Patient-reported outcomes

The analysis showed a statistically significant effect of time on all patient-reported outcomes, including FIQr (P < 0.001), HADS Depression (P < 0.001), HADS Anxiety (P < 0.001), and PCS helplessness (P < 0.001), magnification (P < 0.001), rumination (P < 0.001), and total scores (P < 0.001). These results indicate overall improvements in fibromyalgia-related symptoms, anxiety, depression, and pain across both groups over the intervention period.

A significant group-by-time interaction was observed for HADS Anxiety (P = 0.029, ES = 0.31), reflecting moderate practical significance. The synchronous group demonstrated greater reductions in anxiety levels compared to the asynchronous group by the 8th week. Post-hoc analysis confirmed this finding (P < 0.05), emphasizing the potential advantage of synchronous telerehabilitation for anxiety management.

For other outcomes, including FIQr, HADS Depression, and PCS scores, no significant group-by-time interactions were found (P > 0.05). These results suggest that both asynchronous and synchronous telerehabilitation methods were equally effective in improving these measures (Table 4).

Table 4 Patient-reported outcomes of fibromyalgia survey at different time points and repeated measures ANOVA Results

Quality of life outcomes

A significant effect of time was observed for both Short Form-12 mental (P < 0.001) and physical (P < 0.001) scores, reflecting improvements in health-related quality of life across both groups. Although no significant interaction between group and time was identified for these outcomes (P > 0.05), small effect sizes (ES = 0.24 for physical scores and ES = 0.09 for mental scores) suggest modest but meaningful improvements (Tables 5 and 6).

Table 5 Outcomes related quality of life at different time points and repeated measures ANOVA Results

Table 6 Minimal Clinically Important Difference (MCID) in the overall Visual Analog Scale (VAS) score between the groups

Discussion

This randomized study aimed to compare exercise therapy delivered through an asynchronous video-based tool with synchronous telerehabilitation models on pain, quality of life, functional capacity, muscle strength, joint position sense, anxiety, and depression in individuals diagnosed with FMS. The main findings of the study were that properly planned and followed asynchronous telerehabilitation is as effective as synchronous telerehabilitation in terms of improvement in pain, quality of life, peripheral muscle strength, functional capacity, and decrease in depression risk in patients with FMS. The synchronous telerehabilitation was superior in decreasing the pain in the neck and back, anxiety and, the pain catastrophizing improved the left rotation cervical joint position sense.

Pain

Pain is a common complaint in FMS and is associated with kinesiophobia and affects the quality of life of individuals [38]. Physiotherapy interventions positively affect the quality of life by reducing pain with increased activity. A recent study showed that the telerehabilitation proposal of mind–body had good results in improving painful symptoms and quality of life in patients with FMS [39]. Similarly, a previous study with internet-based basic body awareness therapy concluded with feasible and promising clinical benefits in FMS [40]. Musculoskeletal problems studies have mostly considered synchronized interventions (including therapists accompanying patients in real-time, via videoconference or telephone) in a hybrid format (i.e., in combination with telerehabilitation with in-person rehabilitation care) and asynchronous interventions (where sessions are held, displayed in digital format) independently by the patient) were performed rarely. There has been increased interest in asynchronous telerehabilitation due to some limitations, particularly regarding the scalability of synchrony telerehabilitation and timing constraints [5]. However, studies comparing their effectiveness in relieving pain are rare. This study included the effect of both telerehabilitation interventions on pain. According to the results of our study, both telerehabilitation interventions effectively reduced pain over time, with synchronous therapy showing greater improvement than asynchronous therapy in the neck and neck arm regions. A clinically meaningful change in pain, as measured by the Visual Analog Scale (VAS), was defined as a reduction of at least 1.37 cm on a 10 cm scale. [37]. From baseline to the 4-week assessment, a larger proportion of participants in the Synchronous group achieved the Minimal Clinically Important Difference (MCID) compared to the Asynchronous group across all assessed regions. The current study's pain findings suggest that while both telerehabilitation intervention types effectively reduced pain initially, the Synchronous intervention showed greater early impact, and the maintenance of pain reduction plateaued in the latter phase for both groups. This result may be due to the increase in daily activity performance in the synchronous telerehabilitation group compared to the asynchronous group. Synchronous telerehabilitation can be applied as adjuvant therapy in FMS patients with severe neck and arm pain. The pain reduction observed in the latter phase for both groups might be attributable to the stabilization of daily activity performance in the asynchronous group compared to the synchronous group, where real-time guidance likely promoted better engagement.

Functional capacity

FMS patients have decreased upper and lower limb physical performance, which affects their independence in carrying out daily tasks. This condition is associated with fatigue, decreased functional capacity, and caused pain catastrophizing [41, 42]. Studies reported that aerobic, endurance or low-intensity physical exercise improved the functional capacity in FMS [42, 43]. A previous study concluded that an immediate aerobic exercise-based telerehabilitation program increased the functional capacity in women with FMS [44]. The present study compared delivery telerehabilitation methods that consist of the same program encompassing aerobic, strength training, balance, and flexibility exercises performed with sixty-six FMS patients three times per week for eight weeks. Also, Male and female FMS patients were included in our study. Similarly, an increase in functional capacity was observed in our study. This increase (from 533.18 ± 119.85 m to 576.23 ± 106.73 m in the asynchronous group; from 460.10 ± 64.81 m to 500.00 ± 70.01 in the synchronous group) was significant with time and similar between the groups. The mechanisms underlying acute and chronic aerobic adaptations are likely attributable to enhanced cardiac efficiency, improved oxygen delivery, and the optimization of metabolic pathways [45]. In our study, these adaptations may have been facilitated by the cardiovascular system's ability to more effectively meet the energy and oxygen demands of the musculoskeletal system during physical activity. The observed increase in functional capacity in both groups may be attributed to these physiological improvements. Whether asynchronous or synchronous, female or both gender, short term or long term exercise training improved the functional capacity of FMS patients. It is recommended that future studies investigate the effect of low, high, or intermittent-intensity with differ type of telerehabilitation practices in FMS patients.

Arm muscle strength

The psychological alterations in FMS patients, as with pain, fatigue, and changes in physical capacity, as we mentioned before, affect peripheral muscle strength [46,47,48]. Previous studies showed that strengthening exercises using a swiss ball [49] resistance exercise [50] and muscle energy technique [51] improved muscle strength. Similarly, in the present study, trunk muscle strength was improved within the groups with time by delivery of telerehabilitation methods that consisted of the same program encompassing aerobic, strength training, balance, and flexibility exercises, and this improvement was similar between the groups. This improvement likely reflects the physiological adaptations resulting from regular physical activity and enhanced functional capacity, which are consistent with prior findings.

Joint Position Sense (JPS, LI-RATT)

Preserving head position in space, managing posture, and preserving balance depend on cervical sensorimotor regulation. According to results from a prior study, people with FMS had poor cervical JPS in terms of flexion, extension, and rotation in both the left and right directions. Proprioceptive impairments in FMS patients can be explained by persistent pain, especially in neck and fatigue mechanisms [52]. Another previous study recommended interdisciplinary rehabilitation programs for proprioceptive acuity and stability margins in FMS patients [53]. Both telerehabilitation programs showed improvement in time on the participants' Laser Cursor Assisted Angle Repetition Test extension, flexion, and left rotation scores in the current study. Group and time interaction was medium effective (ES = 0.36) only in LI-RATT left rotation score according to our study results. Mourcou et al. stated that phone-based telerehabilitation could provide patient-specific and personalized exercises to improve proprioceptive functions optimally [54]. We found that asynchronous therapy had a similar effect on servical joint point sense. The current study is the first study that showed the improvements in position sense with two different telerehabilitation programs in FMS. Whether with video or via teleconference, telerehabilitation exercises could improve the joint point sense through sensorimotor conditioning.

FMS symptoms

According to Wu YQ et al.’s study, telerehabilitation can decrease the symptoms of sadness, anxiety, pain intensity, and pain catastrophizing in FMS patients [55]. Similarly, our results showed that both synchronous (from 49,84 [14, 54] to 29,93 (12,84) and asynchronous (from 40,30 (12,06) to28,52 (8,54) telerehabilitation improved the FIQr score which assessed the FMS symptoms. Researchers concluded that telerehabilitation is a useful therapeutic strategy for people with FMS. Adopting a structured aerobic exercise regimen can effectively alleviate symptoms of chronic diseases while improving cardiovascular, musculoskeletal, and metabolic functions. For FMS patients who cannot attend traditional face-to-face services or who live in remote areas, "telerehabilitation can provide accessible and continuous rehabilitation medical services. It may also help patients manage their condition at any time and location in a timely and appropriate manner.

Anxiety and depression

Between 13 and 64% of FMS patients have anxiety problems, while between 20 and 80% have depression [56]. Although there were few studies in both comparison of telerehabilitation approaches. Our results showed that either synchronous or asynchronous telerehabilitation has a significant effect on time but no interaction between group and time in depression in FMS patients. Large-scale randomized controlled trials showing that computerized versions of cognitive behavioral therapy (CBT) delivered via the Internet could lessen symptoms of anxiety with comparable efficacy to face-to-face treatments first revealed the potential of digital technologies in the treatment of anxiety [57]. Another study assessing COVID-19-related anxiety and fear in patients with FMS recommended closely monitoring these individuals for psychological stressors and their effects, particularly through telemedicine applications [58]. Although the current study is unrelated to COVID-19, it similarly demonstrated that two telerehabilitation interventions effectively reduced anxiety scores while closely monitoring participants, consistent with the previous study’s approach. Furthermore, the time × group interaction showed a moderate effect size (ES = 0.31), indicating the extent of the anxiety reduction following the interventions. The greater anxiety reduction observed in the synchronous group could be attributed to the immediate feedback and real-time interaction with physiotherapists, which might foster a greater sense of support and motivation. Another study [59] evaluated the effectiveness of two video-based multicomponent programs, FIBROWALK and the Multicomponent Physiotherapy Program, for patients with FMS compared to treatment-as-usual. FIBROWALK, described as a multicomponent program that incorporates neuroscience education, therapeutic exercise, cognitive-behavioral therapy, and mindfulness training, demonstrated significantly more significant improvements in secondary outcomes, including pain intensity, anxiety (in the complete-case dataset), depressive symptoms, and physical function, compared to Multicomponent Physiotherapy Program. The multicomponent physiotherapy program, in contrast, focuses on pain neuroscience education, therapeutic physical exercise therapy, and self-management patient education. The earlier study [59] compared asynchronous video-based therapies to treatment-as-usual, whereas the current study examines both asynchronous and synchronous therapies in FMS patients. In this study, synchronous and asynchronous telerehabilitation were both effective in reducing depression and anxiety levels among FMS patients. Overall, telemedicine applications—whether asynchronous or synchronous—have proven to be more effective than traditional approaches in alleviating depression and anxiety.

Pain catastrophizing

Pain catastrophizing is an important cognitive factor associated with inadequate functioning in individuals with chronic pain. In recent years, there has been a growing consensus on the importance of improving physical functioning rather than simply reducing pain intensity in people with chronic pain. Consistent with this idea, efforts are being made to shift the focus of pain management from reducing pain to improving the quality of life [60]. Pharmacological treatment, usually used in FMS management and as effective as non-pharmacological treatment, has more side effects and is less accepted by FMS patients.

A non-pharmacological approach, telerehabilitation, has just represented an important rehabilitation resource in many chronic painful pathologies such as spine pain, neurological diseases, and facial palsy [61]. A recent study by Hernando-Garijo et al. reported a telerehabilitation protocol of 15 weeks, with 2 sessions per week, based on aerobic exercise guided by video, that proved effective in reducing pain and psychological distress [44]. Another study showed that 8 weeks of a low-intensity combined physical exercise program, including endurance training and coordination, improved the psychological variables, pain perception, quality of life, and physical conditioning in women with FMS [42]. Contrary to the previous two studies, which included traditional physiotherapy methods and a video-based rehabilitation program, the present study compared two popular telerehabilitation programs based on pain perception. Asynchronous (from 21,71 (9,07) to 12,85 (7,05)) or via synchronous therapy (30,17 (9,22) to (17,32 (7,02)) reduced the pain catastrophizing in FMS patients in our study. Synchronous therapy was found to be more effective only in magnification scores, one of the sub-dimensions of the pain catastrophizing scale, after telerehabilitation. These results may be due to improvements in FMS symptoms, enhanced physical function, and relief from depression and anxiety. Future studies may compare the cost-effectiveness of these synchronous or asynchronous programs in patients whose pain becomes catastrophic.

Health related quality of life

The decrease in the physical and mental distress of the patients after telerehabilitation is associated with an improvement in HrQoL [61]. There was no study evaluating the effectiveness of video-based exercise programs or internet-based simultaneous exercise programs on HrQoL in FMS patients. Mentally and psychologically, the HrQoL showed similar improvements in FMS patients, whether video-based or via synchronous teleconference. Although the synchronous group had higher HrQoL scores, the scores were statistically similar in time and between the groups. Another recently published study showed that synchronous therapy was more effective in improving the scores of physical function and emotional role difficulty sub-parameters in covid 19 patients in the long term [62]. Although the current study was shorter than the previous study, both eight-week telerehabilitation programs showed similar effects in terms of HrQoL in FMS patients. Future studies may investigate the long-term effects of HrQoL with two telerehabilitation programs.

Yuan et al. found that patients with FMS who used the ProFibro app for six weeks had no more impact on symptoms, self-care agency, or HrQoL than a conventional paper book with comparable content [63]. Both groups exhibited improvements in the intensity of symptoms from the baseline, indicating that the self-care program using a paper book or a mobile app may be helpful for people with FMS. Asynchronous and synchronous telerehabilitation also improved HrQoL and reduced symptoms, similar to the previous study. Telerehabilitation interventions may have contributed to the enhanced quality of life in patients with FMS by improving their perception of pain. The cost and time effect of the exercises can be investigated.

In a previous study on beliefs and expectations about telerehabilitation conducted by videoconferencing in women with FMS recruited during the COVID-19 outbreak, the interviews were recorded via software. Women with FMS are expected to benefit from telerehabilitation due to flexible working hours, no need for travel, and increased socialization. They thought they had difficulties during telerehabilitation due to the physical absence of the therapist, the complexity of the exercises, internet connection problems, adaptation to the home routine, and the availability of the programs [64]. Contrary to the previous study, we could not record any interviews via software and study performed with both gender. Information on whether synchronous or asynchronous telerehabilitation protocols meet the expectations of FMS patients is limited.

A recent published review and meta-analysis of 14 RCTs with 1242 FMS patients indicated that telerehabilitation improved the FIQ score, pain intensity, depression level, pain catastrophizing, and HrQoL of patients with FMS compared to control interventions. Only 1 RCT reported a mild adverse event of telerehabilitation; the other 13 RCTs did not mention this, according to the same meta-analyses [55]. In our study, no adverse events related to telerehabilitation were observed, and symptoms were improved in FMS patients. Considering the economic and social benefits, telerehabilitation can be applied to patients with FMS. There are also many potential advantages to telerehabilitation, such as increasing the productivity of healthcare professionals and providing people with various health resources about fibromyalgia and personalized rehabilitation advice. Telerehabilitation can overcome geographical barriers and provide medical care services to people living in rural and remote communities and to patients with FMS who may not be able to attend traditional in-person rehabilitation services. This advantage is particularly important during the COVID-19 pandemic. Although no previous studies have reported the cost-effectiveness of telerehabilitation in FMS, it has been found that telerehabilitation can reduce the monetary and time costs of rehabilitation services [65, 66]. The effectiveness of synchronous and asynchronous telerehabilitation on symptoms was evaluated in the present study. However, future studies may be conducted on the time cost and monetary effect of these methods in FMS.

Exercise through telerehabilitation can be an alternative to enhance physical function and HrQoL in people with impairments, according to the systematic study by Dias et al. [67] Furthermore, Hansen et al. discovered that telerehabilitation helped severe COPD patients recover their lower limb strength and aerobic ability like in-person rehabilitation [68].

Strength and limitations

To our knowledge, this is the first study to search for the equality or superiority of two specific telerehabilitation approaches in patients with FMS. The personalized program, multidimensional program content, and regular motivational interviews and follow-up were the other strengths of the study. In the short term, positive gains were achieved with both telerehabilitation interventions, demonstrating that synchronous and asynchronous telerehabilitation were as effective as the face-to-face inpatient programs previously mentioned in FMS. No adverse events were recorded while performing the two telerehabilitation methods. The study's limitations included short-term planning, unreliable internet connections, challenges in access and evaluation, the implementation of programs by the same physiotherapist, and the absence of a control group.The study experienced a dropout rate of approximately 25.8%, which is notably higher than the initially anticipated 10%. This discrepancy likely stems from various challenges participants faced, including adherence difficulties, technical barriers related to the telerehabilitation intervention, and personal circumstances that led some participants to discontinue the exercises. Specifically, by the first follow-up, a number of participants had either lost contact for non-medical reasons or actively declined to continue, with additional attrition observed at the second follow-up.

This elevated dropout rate introduces the potential for attrition bias, which may affect the generalizability of our findings. Although we used an Intention-to-Treat (ITT) analysis to mitigate bias and maintain the benefits of randomization, the dropout rate could still limit the robustness of the results.

Conclusion

Our results are encouraging: First, telerehabilitation improves the condition of FM patients with a significant reduction in pain, fear of movement, and disability. Secondly, the decrease in the physical and mental distress of the patients during the study highlights the improvement in the HrQoL of the patients due to telerehabilitation. Third, the results of telerehabilitation, whether synchronous or asynchronous, were similar in terms of pain, HrQoL, functional capacity, depression, anxiety, and joint position sense. Using asynchronous approaches can reduce the burden on healthcare professionals and be cost-effective. Future studies may address the impact of different telerehabilitation protocols on the burden of care. We can attribute the good results of both groups to the personalized program, multidimensional program content, and regular motivational interviews and follow-up. This situation may contribute positively to the patient's self-management of the treatment process at the end of the program.