Arthritis, Chronic Pain, Fibromyalgia
Conditions
Brief summary
This study evaluates the effectiveness of wearable biofeedback devices in improving pain, mobility, and rehabilitation outcomes in elderly patients with arthritis and fibromyalgia in Karachi, Pakistan. In a randomized controlled trial involving 120 participants, one group will use biofeedback-integrated devices with guided exercises and virtual consultations, while the control group receives standard physiotherapy. The results will inform the potential of digital health solutions to improve accessibility and outcomes in remote rehabilitation for chronic pain management.
Detailed description
Arthritis and fibromyalgia are common chronic musculoskeletal conditions among the elderly population, contributing to significant pain, reduced mobility, and diminished quality of life. In urban centers like Karachi, Pakistan, access to consistent and effective physiotherapy is often hindered by mobility limitations and inadequate healthcare infrastructure. This randomized controlled trial (RCT) investigates the efficacy of wearable biofeedback devices as an innovative approach to address these challenges. A total of 120 elderly participants diagnosed with arthritis and/or fibromyalgia will be enrolled and randomized into two groups (60 participants per group). The intervention group will receive wearable biofeedback devices that monitor physiological parameters such as heart rate variability (HRV) and provide real-time feedback during guided home-based exercises, complemented by virtual physiotherapy consultations. The control group will follow standard physiotherapy exercise routines without biofeedback or virtual support. Primary outcome measures include pain intensity (measured using a standardized pain scale), functional mobility (assessed via timed mobility tests), and joint range of motion. Secondary outcomes will assess heart rate variability, patient adherence to exercise protocols, and changes in psychological well-being. This study seeks to determine whether wearable biofeedback can enhance rehabilitation outcomes, promote exercise adherence, and offer a viable, accessible alternative to conventional physiotherapy. If successful, the intervention could transform chronic pain management and rehabilitation strategies for aging populations, especially in resource-constrained urban environments.
Interventions
OTHERWearable Biofeedback + Virtual Physiotherapy
Participants will use wearable devices designed to monitor physiological parameters and provide real-time feedback during exercises. The intervention includes remote guidance from physiotherapists via virtual consultations.
Participants will be given printed or video instructions for standard physiotherapy exercises commonly used for arthritis and fibromyalgia management, without any digital monitoring or remote guidance.
Sponsors
Advanced Education & Research Center
University of Karachi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Due to the nature of the intervention (wearable devices and virtual consultations), blinding of participants and care providers is not feasible. This is an open-label study.
Intervention model description
Participants will be randomized into two parallel groups: Intervention Group - receives wearable biofeedback devices with guided exercises and virtual physiotherapy. Control Group - receives standard physiotherapy exercises without biofeedback.
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Elderly adults aged 60-80 years diagnosed with arthritis or fibromyalgia. Experiencing moderate to severe pain and mobility limitations. No recent surgical interventions or contraindications for physiotherapy. Access to smartphones and internet connectivity for remote monitoring.
Exclusion criteria
Patients with severe cognitive impairments affecting adherence to rehabilitation. Presence of comorbidities that contraindicate physiotherapy (e.g., severe cardiac conditions). Lack of access to digital devices required for remote monitoring.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Mobility (Timed Up and Go Test) | Baseline, Week 6, Week 12 | Functional mobility will be assessed using the Timed Up and Go (TUG) Test. Participants will be timed as they rise from a chair, walk 3 meters, turn, return, and sit down again. |
| Range of Motion (Goniometry) | Baseline, Week 6, Week 12 | Joint range of motion will be measured using a goniometer to assess changes in movement capacity of affected joints (e.g., knees, shoulders). |
| Pain Intensity (VAS Score) | Baseline, Week 6, Week 12 | Pain intensity will be measured using the Visual Analog Scale (VAS), a 10-cm horizontal line where participants mark their perceived pain level from 0 (no pain) to 10 (worst imaginable pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| System Usability and Patient Satisfaction | Week 12 | The SUS consists of 10 items, each rated on a 5-point Likert scale (from Strongly Agree to Strongly Disagree). The total score ranges from 0 to 100. A higher score indicates better usability and user satisfaction. |
| Heart Rate Variability (HRV) | Baseline, Week 6, Week 12 | HRV will be evaluated using time-domain (e.g., RMSSD) and frequency-domain (e.g., LF/HF ratio) metrics recorded by wearable devices. |
| Change in Quality of Life (SF-36 Health Survey Score) | Baseline, Week 12 | The SF-36 consists of 8 scaled scores (0-100). Higher scores indicate better health status. |
| Patient Adherence | Throughout the 12-week intervention | Adherence to prescribed exercises will be monitored through device usage logs, measuring frequency and duration of engagement with the intervention. |
| Change in Depression Severity (Beck Depression Inventory Score) | Baseline, Week 12 | The BDI score ranges from 0 to 63. Higher scores indicate more severe depressive symptoms. |
Countries
Pakistan
Contacts
Primary ContactShamoon Noushad, Ph.D.
Outcome results
None listed