Accepted for/Published in: JMIR Formative Research
Date Submitted: Mar 4, 2024
Date Accepted: Jul 16, 2024
Home Transcutaneous Electrical Stimulation Rehabilitation Program for Patients with Ankylosing Spondylitis: a Cross-Over Trial
ABSTRACT
Background:
Maintaining physical function and preserving spinal flexibility have been challenging in managing ankylosing spondylitis (AS). Most rehabilitation programs cannot be performed at home, including manual therapy, massage, hydrotherapy, and acupuncture. The effect of transcutaneous electrical nerve stimulation (TENS) was validated in treating AS, but no home TENS system has explored its efficacy to date.
Objective:
This study aimed to evaluate the efficacy of a home transcutaneous electrical stimulation system on patients with AS.
Methods:
The modified WeHeal® TS-200 TENS and galvanic response system was used to provide home-based TENS treatment on AS. Patients were divided into a two-month course and a one-month course group. After the first treatment course, patients went through a washout period for the same duration of their treatment course. Participants could decide whether to accept the second course of treatment. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Schober’s test, finger-to-floor flexion test, enthesis score, cytokines, chemokines, inflammatory factors, and immunoglobulins were measured to evaluate its efficacy.
Results:
Nine patients (five in a two-month course group and four in a one-month course group) completed the first treatment course, and five patients (four in a two-month course group and one in a one-month course group) completed the sequential treatment course. The weighted results showed that patients reported an improving BASFI score (mean difference, -0.9±1.7; p-value, 0.03) after treatment. Looking into trajectories, declined BASFI and BASDAI scores were noticed during treatments; this score increased during the washout period. There were improving trends in Schober’s test (mean difference, 1.9±4.9) and finger-to-floor flexion test (mean difference, -0.6±9.5), but the results were not statistically significant. The response of cytokines, chemokines, inflammatory factors, and immunoglobulins before and after treatment did not show a consistent trend, and all results were not statistically significant.
Conclusions:
Home TENS device demonstrated a potential role in AS management. It may improve accessibility and adherence for patients with AS and provide remote monitoring for clinicians. Further research can compare the effectiveness of electrotherapy at home or in a medical setting and focus on integrating the home TENS system and exercise program to enhance patients’ physical functions and spinal flexibility. Clinical Trial: Taiwan Clinical trial number: l096607481 Approval date: 5 October 2020
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