HIPS Feasibility RCT Testing a Mind-Body Intervention to Improve Recovery for Individuals With Chronic Hip Pain
Massachusetts General Hospital
Summary
The goal of this clinical trial is to conduct a randomized controlled trial (RCT) to test the feasibility of two dose- and time-matched pain management programs, delivered via live video, for adults with chronic (lasting at least 3 months) and non-arthritic hip-related pain (HRP). Following pre-determined benchmarks, findings from this trial will be used to assess the feasibility, credibility, and acceptability of both programs (HIPS-1, HIPS-2). In preparation for a future clinical trial powered to test efficacy, we will optimize the protocol for patient recruitment, study protocol, and fidelity materials.
Description
Aim: Conduct an RCT testing the feasibility of two dose- and time-matched pain management programs, delivered via live video, for adults with chronic (lasting at least 3 months) and non-arthritic HRP. The ultimate goal of this research is to assess the feasibility, credibility, and acceptability of both interventions (HIPS-1, HIPS-2) and optimize the program and study methodology in preparation for a future RCT powered to assess efficacy. HIPS-1 and HIPS-2 Interventions: Both programs consist of 6 sessions delivered via live video (i.e., Zoom) and are tailored to the needs of patients with no…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Presenting with chronic (lasting ≥3 months) hip joint-related pain 2. Fluent in English 3. Age ≥18yr \[If ≥45yr, the physician will confirm no osteoarthritis via X-ray (Kellgren Lawrence \[KL\] grade 0-1)\] 4. Score ≥3 for current hip pain on the Pain-VAS 5. Psychological risk factor for the maintenance of pain by meeting ≥1 of the criteria listed below: 1. Score ≥ 20 on the PCS 2. Score ≤ 40 on the PSEQ 3. Score ≥ 17 on the TSK-11 6. Exhibits sedentariness or dissatisfaction with physical activity by meeting ≥1 of the criteria listed below: 1. Physically…
Interventions
- BehavioralHIPS-1
HIPS-1 is a 6-session (one 30-minute session per week) mind-body intervention delivered via live-video (i.e., MGB Zoom) by a trained physical therapist (PT). In addition to participating in the HIPS-1 intervention, all participants will attend their prescribed physical therapy with a PT of their choosing. To minimize variability in physical rehabilitation, we will send the PT the Clinical Practice Guidelines, which outline a standard-of-care rehabilitation protocol. Across these six 30-minute sessions, the HIPS-1 intervention aims to teach relaxation and coping skills and provide pain education. After each session, participants will set a physical activity SMART goal for the coming week and complete a weekly check-in survey (i.e., submit weekly home practice, brief pain assessment). All HIPS-1 sessions will be audio-recorded for subsequent interventionist fidelity checks. These recordings will be stored exclusively on MGB-encrypted devices.
- BehavioralHIPS-2
The HIPS-2 program will be administered via live video (i.e., MGB Zoom) and is time and attention-matched to HIPS-1. As such, HIPS-2 is delivered by a trained PT and consists of 6-sessions (one 30-minute session per week). HIPS-2 contains healthy lifestyle education consistent with public health recommendations, including physical activity, sleep, and nutrition. HIPS-2 has no overlap with HIPS-1. In addition to participating in HIPS-2, all those randomized to this condition will attend their prescribed physical therapy with a PT of their choosing and complete a weekly check-in survey (i.e., brief pain assessment). To minimize variability in physical rehabilitation, we will send the PT the Clinical Practice Guidelines, which outline a standard-of-care rehabilitation protocol. All HIPS-2 sessions will be audio-recorded for subsequent interventionist fidelity checks. These recordings will be stored exclusively on MGB-encrypted devices.
Location
- Massachusetts General HospitalBoston, Massachusetts