Effects of adding a diet intervention to exercise on hip osteoarthritis pain: protocol for the ECHO randomized controlled trial

Abstract

Background Hip osteoarthritis (OA) is a leading cause of musculoskeletal pain. Exercise is a core recommended treatment. Despite some clinical guidelines also recommending weight loss for hip OA, there is no evidence from randomised controlled trials (RCT) to substantiate these recommendations. This superiority, 2-group, parallel RCT will compare a combined diet and exercise program to an exercise only program, over 6 months. Methods One hundred people with symptomatic and radiographic hip OA will be recruited from the community. Following baseline assessment, participants will be randomly allocated to either, i) diet and exercise or; ii) exercise only. Participants in the diet and exercise group will have six consultations with a dietitian and five consultations with a physiotherapist via videoconferencing over 6 months. The exercise only group will have five consultations with a physiotherapist via videoconferencing over 6 months. The exercise program for both groups will include prescription of strengthening exercise and a physical activity plan, advice about OA management and additional educational resources. The diet intervention includes prescription of a ketogenic very low-calorie diet with meal replacements and educational resources to support weight loss and healthy eating. Primary outcome is self-reported hip pain via an 11-point numeric rating scale (0 = ‘no pain’ and 10 = ‘worst pain possible’) at 6 months. Secondary outcomes include self-reported body weight (at 0, 6 and 12 months) and body mass index (at 0, 6 and 12 months), visceral fat (measured using dual energy x-ray absorptiometry at 0 and 6 months), pain, physical function, quality of life (all measured using subscales of the Hip Osteoarthritis Outcome Scale at 0, 6 and 12 months), and change in pain and physical activity (measured using 7-point global rating of change Likert scale at 6 and 12 months). Additional measures include adherence, adverse events and cost-effectiveness. Discussion This study will determine whether a diet intervention in addition to exercise provides greater hip pain-relief, compared to exercise alone. Findings will assist clinicians in providing evidence-based advice regarding the effect of a dietary intervention on hip OA pain. Trial registration ClinicalTrials.gov . Identifier: NCT04825483. Registered 31st March 2021.

EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis: 2023 update

“…The authors are also aware of a number of ongoing studies addressing a range of innovative digital programmes in OA care. Such approaches will likely receive further attention in future updates of these recommendations 78–81…”

“…Such approaches will likely receive further attention in future updates of these recommendations. 78–81 …”

“…Such approaches will likely receive further attention in future updates of these recommendations. [78][79][80][81] With regard to outcomes, most of the included studies reported effects primarily on pain and physical function. To follow the recommendations on prioritised outcomes in OA research, 82 more studies investigating the effects of interventions on QoL and patients' global assessment of the target joint may have provided additional relevant information.…”

Physical therapy as a promising treatment for osteoarthritis: A narrative review

“…As an adjunct treatment, physical therapy may work better in combination with other treatments to optimize the effectiveness for OA patients, such as combined with a diet intervention (Hall et al, 2022), pain-reliving drugs (Soriano-Maldonado et al, 2016;Riis et al, 2017) and other treatments.…”