Determining the feasibility of a trial to evaluate the effectiveness of phototherapy versus placebo at reducing pain during physical activity for people with knee osteoarthritis: a pilot randomized controlled trial

Kyle Vader, Abey Bekele Abebe, Mulugeta Bayisa Chala, Kevin Varette, Jordan Miller, Kyle Vader, Abey Bekele Abebe, Mulugeta Bayisa Chala, Kevin Varette, Jordan Miller

Abstract

Background: Although practice guidelines recommend physical activity and exercise for the management of knee osteoarthritis, pain is a common barrier to participation. Phototherapy has been shown to reduce pain intensity for people with knee osteoarthritis, but it is unclear if it reduces pain during physical activity or contributes to improved rehabilitation outcomes.

Objective: The aim of this study is to assess the feasibility of performing a fully powered randomized controlled trial (RCT) comparing an active phototherapy intervention versus placebo on pain during physical activity for people with knee osteoarthritis.

Methods: A pilot RCT was conducted to test the feasibility of a trial comparing 8-sessions (4 weeks) of active phototherapy versus placebo. People were able to participate if they (1) were an English speaking adult (> 18 years of age), (2) had received a diagnosis of knee osteoarthritis from a physician, and (3) self-reported experiencing pain and disability related to their knee osteoarthritis for > 3 months. Primary outcomes were the feasibility of participant recruitment, retention, assessment procedures, and maintaining high treatment fidelity. Secondary outcomes piloted for a full trial included pain during physical activity (primary outcome of full trial); self-reported pain severity, physical function, stiffness, adherence to prescribed exercise, global rating of change, patient satisfaction, and adverse events; 6-min walk test; and pressure pain threshold.

Results: Twenty participants (4 men; 16 women) with knee osteoarthritis and a mean age of 63.95 (SD: 9.27) years were recruited over a 3-week period (6.7 participants per week). Fifteen out of 20 (75%) of participants completed the primary outcome assessment at 4 weeks and 19/20 (95%) of participants were retained and completed the final 16-week assessment. Overall, 89% of all assessment items were completed by participants across all time-points. Fifteen out of 20 participants (75%) completed all 8 treatment sessions. Treatment fidelity was 100% for all completed treatment sessions. No adverse events were reported by participants in either group.

Conclusions: Results suggest that the trial methodology and intervention are feasible for implementation in a fully powered randomized controlled trial to determine the effectiveness of phototherapy at reducing pain during physical activity for people with knee osteoarthritis.

Trial registration: ClinicalTrials.gov , NCT04234685 , January 21, 2020-Retrospectively registered.

Keywords: Knee osteoarthritis; Pain; Phototherapy; Sensitivity to physical activity; disability.

Conflict of interest statement

The authors declare they have no competing interests. The funding for this research came in part from invitalize, who would benefit from positive results in this study. However, invitalize remained at arms length from the investigators throughout data collection, analysis, writing, and publication.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram extension to randomized pilot and feasibility studies

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