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

NCT06820242 | Active Not Recruiting

• 2 other identifiers: 2025P0003055K23AT011922-04
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Pain; Hip Pain Chronic; Mind-Body Therapies

Keywords

chronic hip pain; mind-body; mindfulness

Outcome Measures

Primary Outcomes (10)

• Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire

  Assessed using the Credibility and Expectancy Questionnaire which asks the participant to indicate how much they believe, right now, that the intervention they will receive will help manage their COP and related worry. Possible scores range from 3 to 27 for both the credibility and the expectancy subscales. Higher scores represent higher credibility and expectancy.

  Baseline (0 Weeks)

• Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale

  Measured using the Client Satisfaction Scale which assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.

  Post-Test (6 Weeks)

• Feasibility of recruitment

  The percent of eligible patients approached that agree to participate.

  Baseline (0 Weeks)

• Rate at which program was accepted, measured by number of completed program sessions

  The proportion of participants who attend ≥4 of 6 sessions.

  Post-Test (6 Weeks)

• Feasibility of Assessments at Baseline

  Rate of participant's completion of self-report measures, with no measures missing.

  Baseline (0 Weeks)

• Feasibility of Assessments at Post-Test

  Rate of participant's completion of self-report measures, with no measures missing.

  Post-Test (6 Weeks)

• Feasibility of Assessments at Follow-Up

  Rate of participant's completion of self-report measures, with no measures missing.

  Follow-Up (30 Weeks)

• Adverse Events

  Any self-reported or observed negative events related to participation

  Collected during intervention, an average of 6 weeks

• Therapist adherence

  Rate of interventionist's delivering the programs by following the established session topics and practices

  Collected during intervention, an average of 6 weeks

• Proportion of participants who report symptom improvements as measured by the Global Rating of Change Scale

  The proportion of participants who report overall improvement on the Global Rating of Change Scale. This measure includes a single question asking the patient to rate their change with respect to their hip condition over the last 6 weeks. Higher scores indicate better outcomes.

  Post-Test (6 Weeks)

Secondary Outcomes (10)

• Pain Visual Analogue Scale (Pain-VAS)

  Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

• International Hip Outcome Tool (iHOT-12)

  Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

• PROMIS Pain Interference - Short Form 6b

  Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

• Multidimensional Assessment of Interoceptive Awareness (MAIA)

  Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

• International Physical Activity Questionnaire (IPAQ)

  Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

Study Arms (1)

HIPS

EXPERIMENTAL

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.

Behavioral: HIPS

Interventions

HIPS BEHAVIORAL

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). Across these 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.

HIPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting with chronic (lasting ≥3 months) hip joint-related pain (HRP)
• Age ≥18yr
• a. If ≥45yr, the physician will confirm no osteoarthritis via X-ray (Kellgren Lawrence \[KL\] grade 0-1)
• Score ≥3 for current hip pain on the Pain Visual Analogue Scale (Pain VAS)
• Exhibits poor psychosocial health by meeting ≥1 of the criteria listed below:
• Score ≥ 20 on the Pain Catastrophizing Scale (PCS)
• Score ≤ 40 on the Pain Self-Efficacy Questionnaire (PSEQ)
• Score ≥ 17 on the Tampa Scale for Kinesiophobia (TSK-11)
• Exhibits sedentariness by meeting ≥1 of the criteria listed below:
• Physically active \< 150mins/week according to the International Physical Activity Questionnaire (IPAQ)
• Hip pain interferes with ability to be physically active
• Dissatisfaction with current physical activity level

You may not qualify if:

• Previous surgery on the symptomatic (painful) hip
• Current pain referred from the lower back

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: NIH Stage Model for Behavioral Intervention Development

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: April 4, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)