HIPS Feasibility Randomized Controlled Trial

Официальное название

HIPS Feasibility RCT Testing a Mind-Body Intervention to Improve Recovery for Individuals With Chronic Hip Pain

Обзор

The goal of this clinical trial is to conduct a randomized controlled trial (RCT) to test the feasibility of two dose- and time-matched pain management programs, delivered via live video, for adults with chronic (lasting at least 3 months) and non-arthritic hip-related pain (HRP). Following pre-determined benchmarks, findings from this trial will be used to assess the feasibility, credibility, and acceptability of both programs (HIPS-1, HIPS-2). In preparation for a future clinical trial powered to test efficacy, we will optimize the protocol for patient recruitment, study protocol, and fidelity materials.

Подробное описание

Aim: Conduct an RCT testing the feasibility of two dose- and time-matched pain management programs, delivered via live video, for adults with chronic (lasting at least 3 months) and non-arthritic HRP. The ultimate goal of this research is to assess the feasibility, credibility, and acceptability of both interventions (HIPS-1, HIPS-2) and optimize the program and study methodology in preparation for a future RCT powered to assess efficacy.

HIPS-1 and HIPS-2 Interventions: Both programs consist of 6 sessions delivered via live video (i.e., Zoom) and are tailored to the needs of patients with non-arthritic HRP seeking physical therapy/rehabilitation. Both programs aim to improve the management of the subjects' HRP by providing helpful information. Sessions, regardless of program assignment, are held weekly. In between sessions, subjects complete a brief check-in survey.

Participants will complete the baseline assessment (i.e., digital self-report survey battery). Following the baseline assessment, participants will be randomized to one of the two conditions (HIPS-1, HIPS-2) and complete their 6 program sessions within approximately 6-weeks. Participants will complete additional survey assessments directly following their final program sessions, and once more, 6 months later.

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

Вмешательства

• Поведенческое HIPS-1
  HIPS-1 is a 6-session (one 30-minute session per week) mind-body intervention delivered via live-video (i.e., MGB Zoom) by a trained physical therapist (PT). In addition to participating in the HIPS-1 intervention, all participants will attend their prescribed physical therapy with a PT of their choosing. To minimize variability in physical rehabilitation, we will send the PT the Clinical Practice Guidelines, which outline a standard-of-care rehabilitation protocol. Across these six 30-minute se
• Поведенческое HIPS-2
  The HIPS-2 program will be administered via live video (i.e., MGB Zoom) and is time and attention-matched to HIPS-1. As such, HIPS-2 is delivered by a trained PT and consists of 6-sessions (one 30-minute session per week). HIPS-2 contains healthy lifestyle education consistent with public health recommendations, including physical activity, sleep, and nutrition. HIPS-2 has no overlap with HIPS-1. In addition to participating in HIPS-2, all those randomized to this condition will attend their pre

Первичные конечные точки

• Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale (CSQ) [Срок оценки: Post-Test (6 Weeks)]
• Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ) [Срок оценки: Baseline (0 Weeks)]
• Feasibility of recruitment [Срок оценки: Baseline (0 Weeks)]
• Rate at which program was accepted, measured by number of completed program sessions [Срок оценки: Post-Test (6 Weeks)]
• Feasibility of Assessments at Baseline [Срок оценки: Baseline (0 Weeks)]
• Feasibility of Assessments at Post-Test [Срок оценки: Post-Test (6 Weeks)]
• Feasibility of Assessments at Follow-Up [Срок оценки: Follow-Up (30 Weeks)]
• Intervention fidelity [Срок оценки: Collected during intervention, an average of 6 weeks]
• Proportion of participants who report symptom improvements as measured by the Global Rating of Change (GRoC) Scale [Срок оценки: Post-Test (6 Weeks)]
• Adverse Events [Срок оценки: Collected during intervention, an average of 6 weeks]

Вторичные конечные точки (12)

• Pain Visual Analogue Scale (Pain-VAS) [Срок оценки: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)]
• International Hip Outcome Tool (iHOT-12) [Срок оценки: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)]
• PROMIS Pain Interference - Short Form 6b [Срок оценки: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)]
• Brief Multidimensional Assessment of Interoceptive Awareness 2.0 (MAIA) [Срок оценки: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)]
• Pain Catastrophizing Scale (PCS) [Срок оценки: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)]
• International Physical Activity Questionnaire - Short Form (IPAQ-SF) [Срок оценки: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)]
• Tampa Kinesiophobia Scale (TSK-11) [Срок оценки: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)]
• Pain Self-Efficacy Questionnaire (PSEQ) [Срок оценки: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)]
• Defense and Veterans Pain Rating Scale (DVPRS) - Pain Interference [Срок оценки: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)]
• Chronic Pain Acceptance Questionnaire (CPAQ-8) [Срок оценки: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)]
• Pain Resilience Scale (PRS) [Срок оценки: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)]
• World Health Organization - Five Well-Being Index (WHO-5) [Срок оценки: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)]

Критерии участия

Критерии включения

• Presenting with chronic (lasting ≥3 months) hip joint-related pain
• Fluent in English
• Age ≥18yr \[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-VAS
• Psychological risk factor for the maintenance of pain by meeting ≥1 of the criteria listed below:

• Score ≥ 20 on the PCS
• Score ≤ 40 on the PSEQ
• Score ≥ 17 on the TSK-11
• Exhibits sedentariness or dissatisfaction with physical activity by meeting ≥1 of the criteria listed below:

• Physically active < 150mins/week according to the IPAQ-SF
• Hip pain interferes with the ability to be physically active
• Dissatisfaction with the current physical activity level

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07586397 · 2026P001097 · K23AT011922

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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