HIPS Feasibility Randomized Controlled Trial

NCT07586397 | Not Yet Recruiting DMC

• 2 other identifiers: 2026P001097K23AT011922
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Hip Pain Chronic; Hip Pain; Physical Medicine and Rehabilitation

Keywords

Intervention feasibility; Randomized controlled trial; Behavioral intervention development

Outcome Measures

Primary Outcomes (10)

• 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.

  Post-Test (6 Weeks)

• 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.

  Baseline (0 Weeks)

• Feasibility of recruitment

  The percent of eligible patients approached that agree to participate.

  Baseline (0 Weeks)

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

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

  Post-Test (6 Weeks)

• Feasibility of Assessments at Baseline

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

  Baseline (0 Weeks)

• Feasibility of Assessments at Post-Test

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

  Post-Test (6 Weeks)

• Feasibility of Assessments at Follow-Up

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

  Follow-Up (30 Weeks)

• Intervention fidelity

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

  Collected during intervention, an average of 6 weeks

• 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.

  Post-Test (6 Weeks)

• Adverse Events

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

  Collected during intervention, an average of 6 weeks

Secondary Outcomes (13)

• Pain Visual Analogue Scale (Pain-VAS)

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

• International Hip Outcome Tool (iHOT-12)

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

• PROMIS Pain Interference - Short Form 6b

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

• Brief Multidimensional Assessment of Interoceptive Awareness 2.0 (MAIA)

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

• Pain Catastrophizing Scale (PCS)

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

Study Arms (2)

HIPS-1

EXPERIMENTAL

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.

Behavioral: HIPS-1

HIPS-2

ACTIVE COMPARATOR

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.

Behavioral: HIPS-2

Interventions

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-1

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.

HIPS-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

• Kate Jochimsen, PhD, ATC

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate Jochimsen, PhD, ATC

CONTACT

920-948-7812; kjochimsen@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to whether their assigned intervention is the experimental or the active comparator. The Principal Investigator (PI) will be blinded to the allocation of each randomized participant.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)