Clinical trial NCT06820242: Open Pilot Trial of a Mind-Body Intervention for Patients With Chronic Hip Pain
Official title: Development and Feasibility of a Mind-Body Intervention to Improve Physical Activity for Patients With Chronic Hip Pain: Open Pilot (HIPS Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Pain
Hip Pain Chronic
Mind-Body Therapies
Keywords: chronic hip pain
mind-body
mindfulness
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2025-02-11
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: NIH Stage Model for Behavioral Intervention Development
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire
timeFrame: Baseline (0 Weeks)
measure: Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale
timeFrame: Post-Test (6 Weeks)
measure: Feasibility of recruitment
timeFrame: Baseline (0 Weeks)
measure: Rate at which program was accepted, measured by number of completed program sessions
timeFrame: Post-Test (6 Weeks)
measure: Feasibility of Assessments at Baseline
timeFrame: Baseline (0 Weeks)
measure: Feasibility of Assessments at Post-Test
timeFrame: Post-Test (6 Weeks)
measure: Feasibility of Assessments at Follow-Up
timeFrame: Follow-Up (30 Weeks)
measure: Adverse Events
timeFrame: Collected during intervention, an average of 6 weeks
measure: Therapist adherence
timeFrame: Collected during intervention, an average of 6 weeks
measure: Proportion of participants who report symptom improvements as measured by the Global Rating of Change Scale
timeFrame: Post-Test (6 Weeks)
Secondary outcomes:
measure: Pain Visual Analogue Scale (Pain-VAS)
timeFrame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
measure: International Hip Outcome Tool (iHOT-12)
timeFrame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
measure: PROMIS Pain Interference - Short Form 6b
timeFrame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
measure: Tampa Kinesiophobia Scale (TSK)
timeFrame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
measure: Whole Person Health Index (WPHI)
timeFrame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
measure: Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer
timeFrame: Baseline (0 Weeks), Post-Test (6 Weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: