Hip PainHIPS PilotNCT06820242
Open Pilot Trial of a Mind-Body Intervention for Patients With Chronic Hip Pain
A study testing HIPS in people with Hip Pain and Hip Pain Chronic, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this study is to conduct a feasibility open pilot study (N=5) of HIPS with virtual exit interviews among adult patients with chronic hip joint-related pain (HRP). We will use this mixed methods information to assess the feasibility, credibility, and acceptability of the HIPS intervention and optimize the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Pain, Hip Pain Chronic, Mind-Body Therapies
- What is being tested?
- HIPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2025to 5 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 (HRP)
- 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 Visual Analogue Scale (Pain VAS)
- Exhibits poor psychosocial health by meeting ≥1 of the criteria listed below:
- Score ≥ 20 on the Pain Catastrophizing Scale (PCS)
Show all 12Show fewer
- Score ≤ 40 on the Pain Self-Efficacy Questionnaire (PSEQ)
- Score ≥ 17 on the Tampa Scale for Kinesiophobia (TSK-11)
- Exhibits sedentariness by meeting ≥1 of the criteria listed below:
- Physically active < 150mins/week according to the International Physical Activity Questionnaire (IPAQ)
- Hip pain interferes with ability to be physically active
- Dissatisfaction with 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.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Development and Feasibility of a Mind-Body Intervention to Improve Physical Activity for Patients With Chronic Hip Pain: Open Pilot (HIPS Study)
The goal of this study is to conduct a feasibility open pilot study (N=5) of HIPS with virtual exit interviews among adult patients with chronic hip joint-related pain (HRP). We will use this mixed methods information to assess the feasibility, credibility, and acceptability of the HIPS intervention and optimize the program and study methodology in preparation for a pilot feasibility randomized control trial (RCT).
Deliverables: [1] Adapt and refine open pilot protocol, patient recruitment, provider training, and other study materials. [2] Assess the feasibility, acceptability, and credibility of HIPS in preparation for a future feasibility RCT.
Read the detailed description
Aim: Conduct a feasibility open pilot study (N=5) of HIPS with virtual exit interviews among adult patients with chronic HRP. The ultimate goal of this research is to assess the feasibility, credibility, and acceptability of the HIPS intervention and optimize the program and study methodology in preparation for a pilot feasibility randomized control trial (RCT).
HIPS Intervention: HIPS is a 6-session (one 30-minute session per week) mind-body intervention delivered virtually via live-video by a trained physical therapist (PT). In addition to participating in the HIPS intervention, all participants will attend their prescribed physical therapy with a physical therapist of their choosing. To minimize variability in physical rehabilitation, we will send the physical therapist the Clinical Practice Guidelines, which outline a standard-of-care rehabilitation protocol. Across the six 30-minute sessions, the HIPS intervention aims to teach relaxation and coping skills (e.g., SMART goal-setting, coping thoughts, deep breathing, and progressive muscle relaxation) and provides pain education. After each session, the participant is instructed to set and meet a physical activity SMART goal for the coming week. Within the program manual will be a log where the participant may track their completion of home practice. Each week, participants will receive a survey to formally report their daily home practice data over the last 7 days.
Following program completion, there will be a one-time 30-minute virtual exit interview to elicit subject perceptions of HIPS and any recommendations to improve intervention quality. This information will be used to further adapt and optimize HIPS prior to future efficacy testing.
Assessments: Baseline (0 weeks), post-test (6 weeks), and 6-month follow-up (30 weeks) survey assessments.
- Conditions
- Hip Pain, Hip Pain Chronic, Mind-Body Therapies
- Being tested
- HIPS
- Keywords
- chronic hip pain, mind-body, mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPSBehavioural
HIPS is a 6-session (one 30-minute session per week) mind-body intervention delivered virtually via live video by a trained physical therapist (PT). Across these six 30-minute sessions, the HIPS intervention aims to teach relaxation and coping skills (e.g., SMART goal-setting, coping thoughts, deep breathing, and progressive muscle relaxation) and provides pain education.
| Study group | Role | What they receive |
|---|---|---|
| HIPS | Experimental | A 6-session mind-body intervention that teaches patients with chronic hip joint-related pain (HRP) coping skills (e.g., SMART goal-setting, coping thoughts, deep breathing, and progressive muscle relaxation) and pain education. Receives: Behavioral: HIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire
Assessed using the Credibility and Expectancy Questionnaire which asks the participant to indicate how much they believe, right now, that the intervention they will receive will help manage their COP 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)
Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale
Measured using the Client Satisfaction Scale which assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.
Measured: Post-Test (6 Weeks)
Feasibility of recruitment
The percent of eligible patients approached that agree to participate.
Measured: 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.
Measured: Post-Test (6 Weeks)
Feasibility of Assessments at Baseline
Rate of participant's completion of self-report measures, with no measures missing.
Measured: Baseline (0 Weeks)
Feasibility of Assessments at Post-Test
Rate of participant's completion of self-report measures, with no measures missing.
Measured: Post-Test (6 Weeks)
Feasibility of Assessments at Follow-Up
Rate of participant's completion of self-report measures, with no measures missing.
Measured: Follow-Up (30 Weeks)
Adverse Events
Any self-reported or observed negative events related to participation
Measured: Collected during intervention, an average of 6 weeks
Therapist adherence
Rate of interventionist's delivering the programs by following the established session topics and practices
Measured: Collected during intervention, an average of 6 weeks
Proportion of participants who report symptom improvements as measured by the Global Rating of Change Scale
The proportion of participants who report overall improvement on the Global Rating of Change 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)
Secondary outcomes (10)
Pain Visual Analogue Scale (Pain-VAS)
A single-item scale measuring self-reported pain intensity. 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)
International Hip Outcome Tool (iHOT-12)
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 quality of life
Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
PROMIS Pain Interference - Short Form 6b
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 equate to worse outcomes.
Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Multidimensional Assessment of Interoceptive Awareness (MAIA)
A 32-item state-trait questionnaire to measure multiple dimensions of interception. Scores on item range from 0 to 5 and higher scores translate to better outcomes.
Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
International Physical Activity Questionnaire (IPAQ)
A 27-item self-reported measure assessing physical activity. Overall score on the IPAQ is 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)
Pain Catastrophizing Scale (PCS)
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)
Tampa Kinesiophobia Scale (TSK)
An 11-item questionnaire that assesses fear avoidance and fear of activity. Summary score of total responses with Minimum = 11 and Maximum = 44. Higher scores indicate higher kinesiophobia.
Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Pain Self-Efficacy Questionnaire (PSEQ)
A 10-item measure assessing the confidence people 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)
Whole Person Health Index (WPHI)
A 9-item measure assessing self-reported overall well-being. Each item is rated on a 1-5-point scale (total scores ranging from 9 to 45), with higher scores indicating worse overall well-being.
Measured: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer
Measures the change in steps during the 7 days following the baseline assessment and 7 days preceding the post-test. Larger increase in activity translate to better outcomes.
Measured: Baseline (0 Weeks), Post-Test (6 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start4 Apr 2025
- Primary completion15 Apr 2026
- Study completion5 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- NIH Stage Model for Behavioral Intervention Development
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Kate Jochimsen, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820242
- Sponsor's protocol ID
- 2025P000305
- Other IDs
- 5K23AT011922-04
- Acronym
- HIPS Pilot
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility of a Mind-Body Intervention to Improve Physical Activity for Patients With Chronic Hip Pain: Open Pilot (HIPS Study)
- ClinicalTrials.gov ID
- NCT06820242
- Acronym / sponsor ID
- HIPS Pilot / 2025P000305
- Conditions
- Hip Pain, Hip Pain Chronic, Mind-Body Therapies
- Keywords
- chronic hip pain, mind-body, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 5 Oct 2026 (actual)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to conduct a feasibility open pilot study (N=5) of HIPS with virtual exit interviews among adult patients with chronic hip joint-related pain (HRP). We will use this mixed methods information to assess the feasibility, credibility, and acceptability of the HIPS intervention and optimize the program and study methodology in preparation for a pilot feasibility randomized control trial (RCT).
Deliverables: [1] Adapt and refine open pilot protocol, patient recruitment, provider training, and other study materials. [2] Assess the feasibility, acceptability, and credibility of HIPS in preparation for a future feasibility RCT.
Detailed description
Aim: Conduct a feasibility open pilot study (N=5) of HIPS with virtual exit interviews among adult patients with chronic HRP. The ultimate goal of this research is to assess the feasibility, credibility, and acceptability of the HIPS intervention and optimize the program and study methodology in preparation for a pilot feasibility randomized control trial (RCT).
HIPS Intervention: HIPS is a 6-session (one 30-minute session per week) mind-body intervention delivered virtually via live-video by a trained physical therapist (PT). In addition to participating in the HIPS intervention, all participants will attend their prescribed physical therapy with a physical therapist of their choosing. To minimize variability in physical rehabilitation, we will send the physical therapist the Clinical Practice Guidelines, which outline a standard-of-care rehabilitation protocol. Across the six 30-minute sessions, the HIPS intervention aims to teach relaxation and coping skills (e.g., SMART goal-setting, coping thoughts, deep breathing, and progressive muscle relaxation) and provides pain education. After each session, the participant is instructed to set and meet a physical activity SMART goal for the coming week. Within the program manual will be a log where the participant may track their completion of home practice. Each week, participants will receive a survey to formally report their daily home practice data over the last 7 days.
Following program completion, there will be a one-time 30-minute virtual exit interview to elicit subject perceptions of HIPS and any recommendations to improve intervention quality. This information will be used to further adapt and optimize HIPS prior to future efficacy testing.
Assessments: Baseline (0 weeks), post-test (6 weeks), and 6-month follow-up (30 weeks) survey assessments.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- NIH Stage Model for Behavioral Intervention Development
| Arm | Type | Receives |
|---|---|---|
| HIPS | Experimental | Behavioral: HIPSA 6-session mind-body intervention that teaches patients with chronic hip joint-related pain (HRP) coping skills (e.g., SMART goal-setting, coping thoughts, deep breathing, and progressive muscle relaxation) and pain education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Presenting with chronic (lasting ≥3 months) hip joint-related pain (HRP)
- Age ≥18yr
- Score ≥3 for current hip pain on the Pain Visual Analogue Scale (Pain VAS)
- Exhibits poor psychosocial health by meeting ≥1 of the criteria listed below:
- Exhibits sedentariness by meeting ≥1 of the criteria listed below:
Key exclusion criteria (2 listed)
- Previous surgery on the symptomatic (painful) hip
- Current pain referred from the lower back
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIPSHIPS is a 6-session (one 30-minute session per week) mind-body intervention delivered virtually via live video by a trained physical therapist (PT). Across these six 30-minute sessions, the HIPS intervention aims to teach relaxation and coping skills (e.g., SMART goal-setting, coping thoughts, deep breathing, and progressive muscle relaxation) and provides pain education. | Behavioural | HIPS |
Primary outcome
Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire
Time frame: Baseline (0 Weeks)
Assessed using the Credibility and Expectancy Questionnaire which asks the participant to indicate how much they believe, right now, that the intervention they will receive will help manage their COP 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.
Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale
Time frame: Post-Test (6 Weeks)
Measured using the Client Satisfaction Scale which assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.
Feasibility of recruitment
Time frame: Baseline (0 Weeks)
The percent of eligible patients approached that agree to participate.
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.
Feasibility of Assessments at Baseline
Time frame: Baseline (0 Weeks)
Rate of participant's completion of self-report measures, with no measures missing.
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.
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.
Adverse Events
Time frame: Collected during intervention, an average of 6 weeks
Any self-reported or observed negative events related to participation
Therapist adherence
Time frame: Collected during intervention, an average of 6 weeks
Rate of interventionist's delivering the programs by following the established session topics and practices
Proportion of participants who report symptom improvements as measured by the Global Rating of Change Scale
Time frame: Post-Test (6 Weeks)
The proportion of participants who report overall improvement on the Global Rating of Change 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 secondary outcomes
Pain Visual Analogue Scale (Pain-VAS)
Time frame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
International Hip Outcome Tool (iHOT-12)
Time frame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
PROMIS Pain Interference - Short Form 6b
Time frame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time frame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Pain Catastrophizing Scale (PCS)
Time frame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Tampa Kinesiophobia Scale (TSK)
Time frame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Whole Person Health Index (WPHI)
Time frame: Baseline (0 Weeks), Post-Test (6 Weeks), Follow-Up (30 Weeks)
Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer
Time frame: Baseline (0 Weeks), Post-Test (6 Weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIPS in people with Hip Pain and Hip Pain Chronic, 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: finished, as of the sponsor's last update on 7 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (time frame: Baseline (0 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 7 Oct 2026.