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Hip Pain ChronicHIPS-RCTNCT07586397

HIPS Feasibility Randomized Controlled Trial

A study testing HIPS-1 and HIPS-2 in people with Hip Pain Chronic and Hip Pain, run by Massachusetts General Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HIPS-1 and HIPS-2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
20 Jul 2026to 1 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • Previous surgery on the symptomatic (painful) hip
  • Current pain referred from the lower back

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kate Jochimsen, PhD, ATC contact

920-948-7812

kjochimsen@mgh.harvard.edu

United States1 site, 1 recruiting
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Kate Jochimsen, PhD, ATC, 920-948-7812, kjochimsen@mgh.harvard.edu

    Abigail Kapoor, 617-724-8431, askapoor@mgh.harvard.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Being tested
HIPS-1, HIPS-2
Keywords
Intervention feasibility, Randomized controlled trial, Behavioral intervention development

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIPS-1Behavioural

    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.

  • HIPS-2Behavioural

    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.

Study groups in NCT07586397
Study groupRoleWhat they receive
HIPS-1ExperimentalHIPS-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.
Receives: Behavioral: HIPS-1
HIPS-2Active comparatorThe 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.
Receives: Behavioral: HIPS-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale (CSQ)

    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.

    Measured: Post-Test (6 Weeks)

  2. Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)

    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.

    Measured: Baseline (0 Weeks)

  3. Feasibility of recruitment

    The percent of eligible patients approached that agree to participate.

    Measured: Baseline (0 Weeks)

  4. Rate at which program was accepted, measured by number of completed program sessions

    The proportion of participants who attend ≥4 of 6 sessions.

    Measured: Post-Test (6 Weeks)

  5. Feasibility of Assessments at Baseline

    Rate of participant's completion of self-report measures, with no measures missing.

    Measured: Baseline (0 Weeks)

  6. Feasibility of Assessments at Post-Test

    Rate of participant's completion of self-report measures, with no measures missing.

    Measured: Post-Test (6 Weeks)

  7. Feasibility of Assessments at Follow-Up

    Rate of participant's completion of self-report measures, with no measures missing.

    Measured: Follow-Up (30 Weeks)

  8. Intervention fidelity

    Rate of interventionists delivering the programs by following the established session topics and practices.

    Measured: Collected during intervention, an average of 6 weeks

  9. Proportion of participants who report symptom improvements as measured by the Global Rating of Change (GRoC) Scale

    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.

    Measured: Post-Test (6 Weeks)

  10. Adverse Events

    Any self-reported or observed negative events related to participation.

    Measured: Collected during intervention, an average of 6 weeks

Secondary outcomes (13)
  1. Pain Visual Analogue Scale (Pain-VAS)

    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.

    Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

  2. International Hip Outcome Tool (iHOT-12)

    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.

    Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

  3. PROMIS Pain Interference - Short Form 6b

    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.

    Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

  4. Brief Multidimensional Assessment of Interoceptive Awareness 2.0 (MAIA)

    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.

    Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

  5. Pain Catastrophizing Scale (PCS)

    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).

    Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

  6. International Physical Activity Questionnaire - Short Form (IPAQ-SF)

    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.

    Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

  7. Tampa Kinesiophobia Scale (TSK-11)

    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.

    Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

  8. Pain Self-Efficacy Questionnaire (PSEQ)

    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.

    Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

  9. Defense and Veterans Pain Rating Scale (DVPRS) - Pain Interference

    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.

    Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

  10. Chronic Pain Acceptance Questionnaire (CPAQ-8)

    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.

    Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

  11. Pain Resilience Scale (PRS)

    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).

    Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

  12. World Health Organization - Five Well-Being Index (WHO-5)

    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.

    Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)

  13. Brief Pain Catastrophizing Scale (PCS-3)

    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).

    Measured: Collected weekly thoughout intervention, an average of 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study start20 Jul 2026
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a remote feasibility RCT with pre-, post-, and follow-up assessments to establish the feasibility, acceptability, and credibility of the HIPS-1 and HIPS-2 programs.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07586397
Sponsor's protocol ID
2026P001097
Other IDs
K23AT011922
Acronym
HIPS-RCT
Status last verified
Aug 2026
First submitted
8 May 2026
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No identifiable IDP will be shared with any other researchers. De-identified data may be shared.

Questions about this trial

What is this clinical trial studying?

A study testing HIPS-1 and HIPS-2 in people with Hip Pain Chronic and Hip Pain, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kate Jochimsen, PhD, ATC (920-948-7812, kjochimsen@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale (CSQ) (time frame: Post-Test (6 Weeks)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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