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NCT Number: NCT07586397

HIPS Feasibility Randomized Controlled Trial

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.

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Key information

Conditions

Hip Pain Chronic Hip Pain Physical Medicine and Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

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

Treatment and study plan

HIPS-1

Behavioral

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-2

Behavioral

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Feasibility of recruitment

    Time frame: Baseline (0 Weeks)

    The percent of eligible patients approached that agree to participate.

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

    Time frame: Post-Test (6 Weeks)

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

  5. Feasibility of Assessments at Baseline

    Time frame: Baseline (0 Weeks)

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

  6. Feasibility of Assessments at Post-Test

    Time frame: Post-Test (6 Weeks)

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

  7. Feasibility of Assessments at Follow-Up

    Time frame: Follow-Up (30 Weeks)

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

  8. Intervention fidelity

    Time frame: Collected during intervention, an average of 6 weeks

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

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

    Time frame: 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.

  10. Adverse Events

    Time frame: Collected during intervention, an average of 6 weeks

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

Secondary outcomes

  1. Pain Visual Analogue Scale (Pain-VAS)

    Time frame: 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.

  2. International Hip Outcome Tool (iHOT-12)

    Time frame: 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.

  3. PROMIS Pain Interference - Short Form 6b

    Time frame: 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.

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

    Time frame: 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.

  5. Pain Catastrophizing Scale (PCS)

    Time frame: 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).

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

    Time frame: 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.

  7. Tampa Kinesiophobia Scale (TSK-11)

    Time frame: 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.

  8. Pain Self-Efficacy Questionnaire (PSEQ)

    Time frame: 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.

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

    Time frame: 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.

  10. Chronic Pain Acceptance Questionnaire (CPAQ-8)

    Time frame: 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.

  11. Pain Resilience Scale (PRS)

    Time frame: 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).

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

    Time frame: 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.

  13. Brief Pain Catastrophizing Scale (PCS-3)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Kate Jochimsen, PhD, ATC

CONTACT

[email protected]

920-948-7812

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Acronym: HIPS-RCT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 14, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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