Materials and Methods: A group of 60 participants diagnosed with KOA was randomized into 3 groups of 20 patients each, and treated 6 times over 3 weeks (capsaicin daily) after which the participants returned at 1 week, for a 7th visit follow-up (FU). The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary measures included the Short-Form McGill Pain Questionnaire (SFMPQ), NRS-101 pain scale (NPRS), and goniometry (ROM). Data were collected at baseline, at 6 weeks and at 7th week follow-up. The Kruskal-Wallis tests compared among groups; Friedman’s T-test compared within-group change.
Results: Kruskal-Wallis analysis of inter-group differences among the 3 different treatments at the 7th-week FU was not statistically significant (p= 0.05). Friedman’s intra-group T-test demonstrated statistically significant changes (baseline to 7th-visit FU), however, for all 3 treatments (p=0.05) plus clinically meaningful change in Group 3, mobilization combined with capsaicin for WOMAC, NPRS, and the SFMPQ (p=0.000, p=0.000, p=0.004 respectively), as well as a significantly increased ROM (p=0.000). On the other hand, because Kruskal-Wallis was statistically equivalent at FU, and capsaicin in previous trials has been demonstrated superior to placebo, this suggests Groups 2 and 3 may also be superior to placebo. In fact, the magnitude of change in Friedman’s intra-group T-tests from the 1st to the 7th visit FU (p=0.05) for manipulative therapy, but particularly for Group 3 that combined manipulative therapy with capsaicin, demonstrated significant and clinically meaningful changes in WOMAC of 42.3%, a 22.0 point decrease with NPRS, a decrease of 5.5 points with the SFMPQ, and a significant increase of 5º ROM. These changes appear to compare favorably with exercise and manual therapy trials.
Conclusion: Definitive conclusions await fully powered studies. In this randomized clinical trial, however, significant, clinically meaningful change is supportive of earlier parallel research suggesting that manipulative therapy, particularly combined manipulative therapy with capsaicin, may be helpful in short-term treatment of knee osteoarthritis.
This abstract is reproduced with permission of the publisher. Full text is available by subscription.