Trial results for a study investigating a home-based electrical stimulation program for Osteoarthritis were posted on ClinicalTrials.gov on 2025-07-03. The study, which was terminated, reported that the NMES and FES intervention group showed a mean increase of 198.90 Newtons in quadriceps strength.
Background
Osteoarthritis (OA), particularly knee osteoarthritis (KOA), is a common degenerative joint disease characterized by pain, stiffness, and loss of function. It often leads to disuse atrophy, a weakening and reduction in muscle mass, particularly in the quadriceps, which further exacerbates functional limitations and pain. Current management strategies typically include pain relief, physical therapy, and in some cases, surgical interventions. Non-pharmacological approaches that can improve muscle strength and function are crucial for managing KOA, as they can help combat atrophy and improve overall quality of life for affected individuals. Electrical stimulation, such as neuromuscular electrical stimulation (NMES) and functional electrical stimulation (FES), offers a potential home-based method to strengthen muscles and improve functional capacity.
Trial design
This study, identified as having "NA" phase, was terminated and enrolled 6 participants with Osteoarthritis and Osteoarthritis, Knee. The research aimed to investigate if a 12-week program of stimulation-assisted activities could combat disuse atrophy for individuals diagnosed with knee osteoarthritis. The trial utilized a home-based medical device to administer electrical stimulation. Outcomes measured included quadriceps strength, perceived functional capacity, pain, and walking performance. The study compared a Control group, an NMES (Neuromuscular Electrical Stimulation) group, and an NMES and FES (Functional Electrical Stimulation) group.
Key results
The trial results included several key measurements related to changes from baseline in quadriceps strength and perceived pain scores across the different intervention groups:
- Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline: In the Control group, the mean change was 76.62 Newtons (Full Range).
- Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline: In the NMES group, the mean change was 70.23 Newtons (Full Range).
- Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline: In the NMES and FES group, the mean change was 148.47 Newtons (Full Range).
- Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline: In the Control group, the mean change was 76.38 Newtons (Full Range).
- Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline: In the NMES group, the mean change was 79.90 Newtons (Full Range).
- Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline: In the NMES and FES group, the mean change was 198.90 Newtons (Full Range).
- Change in Perceived Pain Scores From Baseline: In the Control group, the mean change was 0.5 score on a scale (Full Range).
- Change in Perceived Pain Scores From Baseline: In the NMES group, the mean change was -1 score on a scale (Full Range).
- Change in Perceived Pain Scores From Baseline: In the NMES and FES group, the mean change was 1 score on a scale (Full Range).
- Change in Perceived Pain Scores From Baseline: In the Control group, the mean change was -2 score on a scale (Full Range).
- Change in Perceived Pain Scores From Baseline: In the NMES group, the mean change was 0 score on a scale (Full Range).
- Change in Perceived Pain Scores From Baseline: In the NMES and FES group, the mean change was 5 score on a scale (Full Range).
What this means
The posted results from this terminated study, despite its small enrollment of 6 participants, provide initial data on the effects of home-based electrical stimulation for knee osteoarthritis. The NMES and FES group demonstrated the largest mean increase in quadriceps strength, with one measurement showing a change of 198.90 Newtons, suggesting a potential benefit for combating disuse atrophy. Changes in perceived pain scores varied across groups and measurements, with some groups showing slight reductions and others slight increases. Given the termination of the study and the very limited sample size, these findings should be interpreted with caution and cannot support definitive conclusions about the efficacy or safety of the interventions. Further research with larger, completed trials would be necessary to validate these preliminary observations and understand the full clinical implications of electrical stimulation for knee osteoarthritis.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05765435, titled "A 12-Week Home-Based Electrical Stimulation Program for Strength in Adults With Knee Osteoarthritis", were posted on 2025-07-03 on clinicaltrials.gov.