Recruiting

HIPS-1 & HIPS-2

Sponsor:

Massachusetts General Hospital

Code:

NCT07586397

Conditions

Hip Pain Chronic

Hip Pain

Physical Medicine and Rehabilitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HIPS-1

HIPS-2

Study Details

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

Study ID

NCT07586397

Start date

Jul 20, 2026

Status verified date

Aug, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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.

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.

Primary outcome measure

  • Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale (CSQ) [ Time Frame: Post-Test (6 Weeks) ]
  • Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ) [ Time Frame: Baseline (0 Weeks) ]
  • Feasibility of recruitment [ Time Frame: Baseline (0 Weeks) ]
  • Rate at which program was accepted, measured by number of completed program sessions [ Time Frame: Post-Test (6 Weeks) ]
  • Feasibility of Assessments at Baseline [ Time Frame: Baseline (0 Weeks) ]
  • Feasibility of Assessments at Post-Test [ Time Frame: Post-Test (6 Weeks) ]
  • Feasibility of Assessments at Follow-Up [ Time Frame: Follow-Up (30 Weeks) ]
  • Intervention fidelity [ Time Frame: 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 [ Time Frame: Post-Test (6 Weeks) ]
  • Adverse Events [ Time Frame: Collected during intervention, an average of 6 weeks ]

Central Contacts and Locations

Central contacts

Kate Jochimsen, PhD, ATC

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Kate Jochimsen, PhD, ATC

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

Abigail Kapoor

617-724-8431askapoor@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Intervention feasibility
  • Randomized controlled trial
  • Behavioral intervention development

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-08-10.