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Completed
NCT06820242
Open Pilot Trial of a Mind-Body Intervention for Patients With Chronic Hip Pain
Conditions: Hip Pain, Hip Pain Chronic, Mind-Body Therapies
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 6
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
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.
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
Source: ClinicalTrials.gov (NCT06820242). StuddyBuddy aggregates publicly available trial information.