NCT07586397NARecruiting

HIPS Feasibility Randomized Controlled Trial

Massachusetts General Hospital

Start Date

7/20/2026

Completion Date

6/1/2028

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.

Detailed 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 non-arthritic HRP seeking physical therapy/rehabilitation. Both programs aim to improve the management of the subjects' HRP by providing helpful information. Sessions, regardless of program assignment, are held weekly. In between sessions, subjects complete a brief check-in survey. Participants will complete the baseline assessment (i.e., digital self-report survey battery). Following the baseline assessment, participants will be randomized to one of the two conditions (HIPS-1, HIPS-2) and complete their 6 program sessions within approximately 6-weeks. Participants will complete additional survey assessments directly following their final program sessions, and once more, 6 months later. Assessments: Baseline (0 weeks), post-test (6 weeks), and 6-month follow-up (30 weeks) survey assessments.

Eligibility Criteria

Age Range: 18 years to No maximum

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 active \< 150mins/week according to the IPAQ-SF 2. Hip pain interferes with the ability to be physically active 3. Dissatisfaction with the current physical activity level Exclusion Criteria: 1. Previous surgery on the symptomatic (painful) hip 2. Current pain referred from the lower back

Interventions

BEHAVIORAL

HIPS-1

BEHAVIORAL

HIPS-2

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Conditions

Hip Pain ChronicHip PainPhysical Medicine and Rehabilitation

Locations

Massachusetts General Hospital

Boston, Massachusetts 02114

United States