Open Pilot Trial of a Mind-Body Intervention for Patients With Chronic Hip Pain (HIPS Pilot)

Mass General Brigham

Status: Enrolling

Conditions: Hip Pain; Hip Pain Chronic; Mind-Body Therapies

Treatments: Behavioral: HIPS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06820242

2025P000305

5K23AT011922-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this study is to conduct a feasibility open pilot study (N=5) of HIPS with virtual exit interviews among adult patients with chronic hip joint-related pain (HRP). We will use this mixed methods information to assess the feasibility, credibility, and acceptability of the HIPS intervention and optimize the program and study methodology in preparation for a pilot feasibility randomized control trial (RCT).

Deliverables: [1] Adapt and refine open pilot protocol, patient recruitment, provider training, and other study materials. [2] Assess the feasibility, acceptability, and credibility of HIPS in preparation for a future feasibility RCT.

Full description

Aim: Conduct a feasibility open pilot study (N=5) of HIPS with virtual exit interviews among adult patients with chronic HRP. The ultimate goal of this research is to assess the feasibility, credibility, and acceptability of the HIPS intervention and optimize the program and study methodology in preparation for a pilot feasibility randomized control trial (RCT).

HIPS Intervention: HIPS is a 6-session (one 30-minute session per week) mind-body intervention delivered virtually via live-video by a trained physical therapist (PT). In addition to participating in the HIPS intervention, all participants will attend their prescribed physical therapy with a physical therapist of their choosing. To minimize variability in physical rehabilitation, we will send the physical therapist the Clinical Practice Guidelines, which outline a standard-of-care rehabilitation protocol. Across the six 30-minute sessions, the HIPS intervention aims to teach relaxation and coping skills (e.g., SMART goal-setting, coping thoughts, deep breathing, and progressive muscle relaxation) and provides pain education. After each session, the participant is instructed to set and meet a physical activity SMART goal for the coming week. Within the program manual will be a log where the participant may track their completion of home practice. Each week, participants will receive a survey to formally report their daily home practice data over the last 7 days.

Following program completion, there will be a one-time 30-minute virtual exit interview to elicit subject perceptions of HIPS and any recommendations to improve intervention quality. This information will be used to further adapt and optimize HIPS prior to future efficacy testing.

Assessments: Baseline (0 weeks), post-test (6 weeks), and 6-month follow-up (30 weeks) survey assessments.

Enrollment: 5 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Presenting with chronic (lasting ≥3 months) hip joint-related pain (HRP)

2. Age ≥18yr

   a. If ≥45yr, the physician will confirm no osteoarthritis via X-ray (Kellgren Lawrence [KL] grade 0-1)

3. Score ≥3 for current hip pain on the Pain Visual Analogue Scale (Pain VAS)

4. Exhibits poor psychosocial health by meeting ≥1 of the criteria listed below:

   1. Score ≥ 20 on the Pain Catastrophizing Scale (PCS)
   2. Score ≤ 40 on the Pain Self-Efficacy Questionnaire (PSEQ)
   3. Score ≥ 17 on the Tampa Scale for Kinesiophobia (TSK-11)

5. Exhibits sedentariness by meeting ≥1 of the criteria listed below:

   1. Physically active < 150mins/week according to the International Physical Activity Questionnaire (IPAQ)
   2. Hip pain interferes with ability to be physically active
   3. Dissatisfaction with current physical activity level

Exclusion criteria

1. Previous surgery on the symptomatic (painful) hip
2. Current pain referred from the lower back

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

HIPS

Experimental group

Description:

A 6-session mind-body intervention that teaches patients with chronic hip joint-related pain (HRP) coping skills (e.g., SMART goal-setting, coping thoughts, deep breathing, and progressive muscle relaxation) and pain education.

Treatment:

Behavioral: HIPS