HIPS Feasibility RCT Testing a Mind-Body Intervention to Improve Recovery for Individuals With Chronic Hip Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale (CSQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants are blinded to whether their assigned intervention is the experimental or the active comparator. The Principal Investigator (PI) will be blinded to the allocation of each randomized participant.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Previous surgery on the symptomatic (painful) hip
- •Current pain referred from the lower back
研究组 & 干预措施
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 prescribed physical therapy with a PT of their choosing and complete a weekly check-in survey (i.e., brief pain assessment). To minimize variability in physical rehabilitation, we will send the PT the Clinical Practice Guidelines, which outline a standard-of-care rehabilitation protocol. All HIPS-2 sessions will be audio-recorded for subsequent interventionist fidelity checks. These recordings will be stored exclusively on MGB-encrypted devices.
干预措施: HIPS-2 (Behavioral)
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 sessions, the HIPS-1 intervention aims to teach relaxation and coping skills and provide pain education. After each session, participants will set a physical activity SMART goal for the coming week and complete a weekly check-in survey (i.e., submit weekly home practice, brief pain assessment). All HIPS-1 sessions will be audio-recorded for subsequent interventionist fidelity checks. These recordings will be stored exclusively on MGB-encrypted devices.
干预措施: HIPS-1 (Behavioral)
结局指标
主要结局
Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale (CSQ)
时间窗: Post-Test (6 Weeks)
Measured using the CSQ, which assesses participants' satisfaction with participation in the study. The score range is 0-12, with higher scores indicating greater satisfaction.
Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)
时间窗: Baseline (0 Weeks)
Assessed using the CEQ, which asks the participant to indicate how much they believe, right now, that the intervention they will receive will help manage their HRP 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 recruitment
时间窗: 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
时间窗: Post-Test (6 Weeks)
The proportion of participants who attend ≥4 of 6 sessions.
Feasibility of Assessments at Baseline
时间窗: Baseline (0 Weeks)
Rate of participant's completion of self-report measures, with no measures missing.
Feasibility of Assessments at Post-Test
时间窗: Post-Test (6 Weeks)
Rate of participant's completion of self-report measures, with no measures missing.
Feasibility of Assessments at Follow-Up
时间窗: Follow-Up (30 Weeks)
Rate of participant's completion of self-report measures, with no measures missing.
Intervention fidelity
时间窗: Collected during intervention, an average of 6 weeks
Rate of interventionists delivering the programs by following the established session topics and practices.
Proportion of participants who report symptom improvements as measured by the Global Rating of Change (GRoC) Scale
时间窗: Post-Test (6 Weeks)
The proportion of participants who report overall improvement on the GRoC 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.
Adverse Events
时间窗: Collected during intervention, an average of 6 weeks
Any self-reported or observed negative events related to participation.
次要结局
- 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))
- Brief Multidimensional Assessment of Interoceptive Awareness 2.0 (MAIA)(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- Pain Catastrophizing Scale (PCS)(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- International Physical Activity Questionnaire - Short Form (IPAQ-SF)(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- Tampa Kinesiophobia Scale (TSK-11)(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- Pain Self-Efficacy Questionnaire (PSEQ)(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- Defense and Veterans Pain Rating Scale (DVPRS) - Pain Interference(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- Chronic Pain Acceptance Questionnaire (CPAQ-8)(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- Pain Resilience Scale (PRS)(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- World Health Organization - Five Well-Being Index (WHO-5)(Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks))
- Brief Pain Catastrophizing Scale (PCS-3)(Collected weekly thoughout intervention, an average of 6 weeks)
研究者
Kate Jochimsen
Principal Investigator
Massachusetts General Hospital