HIPS Feasibility Randomized Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous surgery on the symptomatic (painful) hip
Current pain referred from the lower back
Trial design
Design model
Parallel
Treatments tested in this trial
HIPS-1
BehavioralHIPS-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
BehavioralThe 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: HIPS-1Experimental treatment 1 intervention
Group B: HIPS-2Active comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
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.
Time frame
Baseline (0 Weeks)3
Feasibility of recruitment
The percent of eligible patients approached that agree to participate.
Time frame
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.
Time frame
Post-Test (6 Weeks)Secondary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
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.
Time frame
Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov