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

Not Applicable

Recruiting

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

• Registration Number: NCT06820242
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed 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 in person 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.

Study Timeline

• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-11
• Status Verified: 2025-04
• Study Start: 2025-04-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-06
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale	Post-Test (6 Weeks)	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.
Therapist adherence	Collected during intervention, an average of 6 weeks	Rate of interventionist's delivering the programs by following the established session topics and practices
Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire	Baseline (0 Weeks)	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.
Feasibility of Assessments at Follow-Up	Follow-Up (30 Weeks)	Rate of participant's completion of self-report measures, with no measures missing.
Feasibility of recruitment	Baseline (0 Weeks)	The percent of eligible patients approached that agree to participate.
Rate at which program was accepted, measured by number of completed program sessions	Post-Test (6 Weeks)	The proportion of participants who attend ≥4 of 6 sessions.
Feasibility of Assessments at Baseline	Baseline (0 Weeks)	Rate of participant's completion of self-report measures, with no measures missing.
Feasibility of Assessments at Post-Test	Post-Test (6 Weeks)	Rate of participant's completion of self-report measures, with no measures missing.
Adverse Events	Collected during intervention, an average of 6 weeks	Any self-reported or observed negative events related to participation
Proportion of participants who report symptom improvements as measured by the Global Rating of Change Scale	Post-Test (6 Weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Pain Visual Analogue Scale (Pain-VAS)	Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)	A single-item scale measuring self-reported pain intensity. Scores on the Pain-VAS range from 0 (no pain) to 100 (worst pain imaginable) and higher scores equate to worse outcomes.
International Hip Outcome Tool (iHOT-12)	Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)	A 12-item questionnaire to assess deficiencies with respect to outcome assessment for young, active patients with hip disorders. Total scores range from 0 to 100 and higher scores represent better quality of life
PROMIS Pain Interference - Short Form 6b	Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)	A 6-item measure assessing self-reported consequences of pain on relevant aspects of a person's life and including the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Scores range from 6 to 30 where higher scores equate to worse outcomes.
Multidimensional Assessment of Interoceptive Awareness (MAIA)	Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)	A 32-item state-trait questionnaire to measure multiple dimensions of interception. Scores on item range from 0 to 5 and higher scores translate to better outcomes.
International Physical Activity Questionnaire (IPAQ)	Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)	A 27-item self-reported measure assessing physical activity. Overall score on the IPAQ is calculated using responses to all questions. More physical activity translates to better outcomes.
Pain Catastrophizing Scale (PCS)	Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)	A 13-item questionnaire assessing one's tendency to focus on pain-related thoughts and feel helpless and hopeless due to pain on a scale of 0 to 4. Total scores range from 0 to 25 and higher scores indicate higher pain catastrophizing (worse outcomes).
Tampa Kinesiophobia Scale (TSK)	Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)	An 11-item questionnaire that assesses fear avoidance and fear of activity. Summary score of total responses with Minimum = 11 and Maximum = 44. Higher scores indicate higher kinesiophobia.
Pain Self-Efficacy Questionnaire (PSEQ)	Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)	A 10-item measure assessing the confidence people with ongoing pain have in performing activities while in pain. Each item is scored on a 7-point Likert scale where 0 (not at all confident) and 6 (completely confident). Total scores range from 0 to 60 and higher scores translate to better outcomes.
Whole Person Health Index (WPHI)	Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)	A 9-item measure assessing self-reported overall well-being. Each item is rated on a 1-5-point scale (total scores ranging from 9 to 45), with higher scores indicating worse overall well-being.
Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer	Baseline (0 Weeks), Post-Test (6 Weeks)	Measures the change in steps during the 7 days following the baseline assessment and 7 days preceding the post-test. Larger increase in activity translate to better outcomes.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States