此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

HIPS Feasibility Randomized Controlled Trial (HIPS-RCT)

2026年8月6日 更新者：Kate Jochimsen、Massachusetts General Hospital

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

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Massachusetts
      • Boston、Massachusetts、美国、02114

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Presenting with chronic (lasting ≥3 months) hip joint-related pain
  2. Fluent in English
  3. Age ≥18yr [If ≥45yr, the physician will confirm no osteoarthritis via X-ray (Kellgren Lawrence [KL] grade 0-1)]
  4. Score ≥3 for current hip pain on the Pain-VAS

  5. Psychological risk factor for the maintenance of pain by meeting ≥1 of the criteria listed below:

    1. Score ≥ 20 on the PCS
    2. Score ≤ 40 on the PSEQ
    3. Score ≥ 17 on the TSK-11

  6. Exhibits sedentariness or dissatisfaction with physical activity by meeting ≥1 of the criteria listed below:

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

Exclusion Criteria:

  1. Previous surgery on the symptomatic (painful) hip
  2. Current pain referred from the lower back

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
行为的：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.
有源比较器：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.
行为的：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
招聘的可行性
大体时间：基线（0 周）
符合条件的患者同意参与的百分比。
基线（0 周）
基线评估的可行性
大体时间：基线（0 周）
参与者完成自我报告措施（不遗漏任何措施）的比率。
基线（0 周）
接受哪个计划的比率，按完成的计划会议数量来衡量
大体时间：测试后（6周）
参加6次会议中≥4的参与者的比例。
测试后（6周）
测试后评估的可行性
大体时间：测试后（6周）
参与者完成自我报告措施的速度，没有措施丢失。
测试后（6周）
随访时评估的可行性
大体时间：随访（30周）
参与者完成自我报告措施的速度，没有措施丢失。
随访（30周）
Intervention fidelity
大体时间：Collected during intervention, an average of 6 weeks
Rate of interventionists delivering the programs by following the established session topics and practices.
Collected during intervention, an average of 6 weeks
Adverse Events
大体时间：Collected during intervention, an average of 6 weeks
Any self-reported or observed negative events related to participation.
Collected during intervention, an average of 6 weeks
Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale (CSQ)
大体时间：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.
Post-Test (6 Weeks)
Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)
大体时间：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.
Baseline (0 Weeks)
Proportion of participants who report symptom improvements as measured by the Global Rating of Change (GRoC) Scale
大体时间：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.
Post-Test (6 Weeks)

次要结果测量

结果测量
措施说明
大体时间
Pain Visual Analogue Scale (Pain-VAS)
大体时间：Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
The Pain-VAS is a single-item scale measuring self-reported pain intensity (worst and average). Scores on the Pain-VAS range from 0 (no pain) to 100 (worst pain imaginable), and higher scores equate to worse outcomes.
Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
International Hip Outcome Tool (iHOT-12)
大体时间：Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
The iHOT-12 is 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 outcomes.
Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
PROMIS Pain Interference - Short Form 6b
大体时间：Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
This is 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 indicate worse outcomes.
Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Brief Multidimensional Assessment of Interoceptive Awareness 2.0 (MAIA)
大体时间：Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
The MAIA-2.0 is a 24-item state-trait questionnaire to measure multiple dimensions of interoception. Each item is scored on a 0 to 5 scale. Higher scores translate to better outcomes.
Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Pain Catastrophizing Scale (PCS)
大体时间：Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
The PCS is 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).
Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
大体时间：Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
The IPAQ-SF is a 7-item self-reported measure assessing physical activity. Overall scores on this measure are calculated using responses to all questions. More physical activity translates to better outcomes.
Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Tampa Kinesiophobia Scale (TSK-11)
大体时间：Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
The TSK-11 is an 11-item questionnaire assessing fear avoidance and fear of activity. Summary scores range from 11 (minimum) to 44 (maximum). Higher scores indicate higher kinesiophobia and worse outcomes.
Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Pain Self-Efficacy Questionnaire (PSEQ)
大体时间：Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
The PSEQ is a 10-item measure assessing the confidence those 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.
Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Defense and Veterans Pain Rating Scale (DVPRS) - Pain Interference
大体时间：Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
The DVPRS for Pain Interference is a 5-item measure assessing pain interference on a 10-point Likert scale where 10 = "complete interference" and 0 = "no interference". Higher scores indicate worse outcomes.
Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Chronic Pain Acceptance Questionnaire (CPAQ-8)
大体时间：Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
The CPAQ-8 is an 8-item measure assessing acceptance of pain on two sub-scales (Activity Engagement and Pain Willingness). Higher scores indicate higher levels of acceptance and better outcomes.
Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Pain Resilience Scale (PRS)
大体时间：Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
The PRS is a 14-item measure assessing pain resilience on two main dimensions (cognitive/affective positivity and behavioral perseverance). Respondents rate each item on a 0 ("Not at all") to 4 ("All the time") scale. Higher total scores indicate better outcomes (greater resilience).
Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
World Health Organization - Five Well-Being Index (WHO-5)
大体时间：Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
The WHO-5 Well-Being Index is a 5-item measure assessing general mental well-being on a 6-point scale. Raw score ranges from 0 to 25. To calculate the final score, the raw score is multiplied by 4, producing a percentage score from 0 to 100, where greater scores reflect better well-being.
Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Brief Pain Catastrophizing Scale (PCS-3)
大体时间：Collected weekly thoughout intervention, an average of 6 weeks
The PCS-3 is a 3-item version of the PCS assessing one's tendency to focus on pain-related thoughts and feel helpless and hopeless due to pain on a 0 to 4 scale. Total scores range from 0 to 12, and higher scores indicate higher pain catastrophizing (worse outcomes).
Collected weekly thoughout intervention, an average of 6 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Massachusetts General Hospital

合作者

National Center for Complementary and Integrative Health (NCCIH)

调查人员

  • 首席研究员：Kate Jochimsen, PhD, ATC、Massachusetts General Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月20日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年5月8日

首先提交符合 QC 标准的

2026年5月8日

首次发布 (实际的)

2026年5月14日

研究记录更新

最后更新发布 (实际的)

2026年8月10日

上次提交的符合 QC 标准的更新

2026年8月6日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 2026P001097
  • K23AT011922 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

No identifiable IDP will be shared with any other researchers. De-identified data may be shared.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅