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HIPS Feasibility Randomized Controlled Trial (HIPS-RCT)

13. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Aktiv komparator: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mulighet for rekruttering
Tidsramme: Grunnlinje (0 uker)
Prosentandelen av kvalifiserte pasienter henvendte seg som godtar å delta.
Grunnlinje (0 uker)
Gjennomførbarhet av vurderinger ved baseline
Tidsramme: Grunnlinje (0 uker)
Frekvens for deltakerens gjennomføring av egenrapporteringstiltak, uten at noen mål mangler.
Grunnlinje (0 uker)
Rate som programmet ble akseptert, målt etter antall fullførte programøkter
Tidsramme: Post-test (6 uker)
Andelen deltakere som deltar ≥4 av 6 økter.
Post-test (6 uker)
Mulighet for vurderinger ved post-test
Tidsramme: Post-test (6 uker)
Deltakernes fullføring av selvrapporteringstiltak, uten tiltak som mangler.
Post-test (6 uker)
Mulighet for vurderinger ved oppfølging
Tidsramme: Oppfølging (30 uker)
Deltakernes fullføring av selvrapporteringstiltak, uten tiltak som mangler.
Oppfølging (30 uker)
Intervention fidelity
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain Visual Analogue Scale (Pain-VAS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Massachusetts General Hospital

Samarbeidspartnere

National Center for Complementary and Integrative Health (NCCIH)

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. juni 2028

Datoer for studieregistrering

Først innsendt

8. mai 2026

Først innsendt som oppfylte QC-kriteriene

8. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 2026P001097
  • K23AT011922 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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