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HIPS Feasibility Randomized Controlled Trial (HIPS-RCT)

2026. augusztus 6. frissítette: 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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

50

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Egyéb
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Hármas

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.
Viselkedési: 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.
Aktív összehasonlító: 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.
Viselkedési: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
A toborzás megvalósíthatósága
Időkeret: Alapállapot (0 hét)
Azon jogosult betegek százalékos aránya, akik beleegyeztek a részvételbe.
Alapállapot (0 hét)
A kiindulási értékelések megvalósíthatósága
Időkeret: Alapállapot (0 hét)
A résztvevők által elvégzett önbevallási intézkedések aránya, és egyetlen intézkedés sem hiányzik.
Alapállapot (0 hét)
A program elfogadásának mértéke, amelyet a kitöltött programszámok száma alapján mérnek
Időkeret: Post-teszt (6 hét)
A 6 ülésből ≥4 résztvevők aránya.
Post-teszt (6 hét)
Az értékelések megvalósíthatósága a teszt utáni vizsgálatnál
Időkeret: Post-teszt (6 hét)
A résztvevő önjelentési intézkedéseinek befejezésének üteme, anélkül, hogy hiányoznának.
Post-teszt (6 hét)
Az értékelések megvalósíthatósága a nyomon követéskor
Időkeret: Nyomon követés (30 hét)
A résztvevő önjelentési intézkedéseinek befejezésének üteme, anélkül, hogy hiányoznának.
Nyomon követés (30 hét)
Intervention fidelity
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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)

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Pain Visual Analogue Scale (Pain-VAS)
Időkeret: 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)
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Massachusetts General Hospital

Együttműködők

National Center for Complementary and Integrative Health (NCCIH)

Nyomozók

  • Kutatásvezető: Kate Jochimsen, PhD, ATC, Massachusetts General Hospital

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2026. július 20.

Elsődleges befejezés (Becsült)

2027. december 1.

A tanulmány befejezése (Becsült)

2028. június 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. május 8.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. május 8.

Első közzététel (Tényleges)

2026. május 14.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. augusztus 10.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 6.

Utolsó ellenőrzés

2026. augusztus 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

Egyéb vizsgálati azonosító számok

  • 2026P001097
  • K23AT011922 (Az Egyesült Államok NIH támogatása/szerződése)

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

IPD terv leírása

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

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