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HIPS Feasibility Randomized Controlled Trial (HIPS-RCT)

2026年5月13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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

50

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：他の
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：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.
アクティブコンパレータ：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.
行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
採用の可能性
時間枠：ベースライン (0 週間)
参加に同意した適格患者の割合。
ベースライン (0 週間)
ベースラインでの評価の実現可能性
時間枠：ベースライン (0 週間)
参加者の自己申告による対策の完了率（対策漏れなし）。
ベースライン (0 週間)
完了したプログラムセッションの数で測定されたプログラムが受け入れられたレート
時間枠：テスト後（6週間）
6セッションのうち4セッションに参加する参加者の割合。
テスト後（6週間）
テスト後の評価の実現可能性
時間枠：テスト後（6週間）
参加者の自己報告措置の完了率はありませんが、測定はありません。
テスト後（6週間）
フォローアップ時の評価の実現可能性
時間枠：フォローアップ（30週間）
参加者の自己報告措置の完了率はありませんが、測定はありません。
フォローアップ（30週間）
Intervention fidelity
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Pain Visual Analogue Scale (Pain-VAS)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Massachusetts General Hospital

協力者

National Center for Complementary and Integrative Health (NCCIH)

捜査官

  • 主任研究者：Kate Jochimsen, PhD, ATC、Massachusetts General Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2027年12月1日

研究の完了 (推定)

2028年6月1日

試験登録日

最初に提出

2026年5月8日

QC基準を満たした最初の提出物

2026年5月8日

最初の投稿 (実際)

2026年5月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月15日

QC基準を満たした最後の更新が送信されました

2026年5月13日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • 2026P001097
  • K23AT011922 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

慢性股関節痛の臨床試験

HIPS-1の臨床試験

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