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HIPS Feasibility Randomized Controlled Trial

HIPS Feasibility Randomized Controlled Trial

Recruiting
18 years and older
All
Phase N/A

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Overview

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 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

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

Study details
    Hip Pain Chronic
    Hip Pain
    Physical Medicine and Rehabilitation

NCT07586397

Massachusetts General Hospital

11 July 2026

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