- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03519087
Nonarthritic Hip Disease Evaluation And Treatment (NEAT)
Informed Decisions and Patient Outcomes: An Interdisciplinary Approach to Chronic Hip Pain
Study Overview
Status
Conditions
Detailed Description
The clinical evaluation by the physician is standard-of-care and performed as part of potential participants' scheduled appointment. Participants in this study will complete a HIPAA authorization to allow data from their clinical evaluation by the physician to be utilized for this study, including any imaging the physician used in their clinical evaluation and the evaluation note entered into the participant's electronic health record. The physician notes are standardized, allowing streamlined data analysis from the electronic health record.
Research activities to occur the same day as the informed consent process include randomization to receive or not receive a clinical evaluation by a physical therapist along with surveys for treatment decisions, expected outcomes, and patient-reported function. A small sub-group of patients will also complete interviews to identify how they felt about their evaluation that day. The HIPAA authorization will also allow the data from the physical therapy evaluation and any subsequent posture and movement training at OSUWMC to be utilized for this study.
Regardless of randomization to receive or not receive a same-day physical therapy evaluation in the physician clinic, all participants will be randomized to receive posture and movement training (PMT) or undergo a 3-week wait period. Participants who are randomized to receive PMT as part of this research study will schedule based on their availability, twice weekly for 3 weeks with an OSUWMC Sports Medicine physical therapist who also hold IRB-approved status as research personnel. Participants will be made aware during the informed consent process that any PMT they receive as part of this study will be their responsibility to pay for using either self-pay or insurance-based methods.
Participants who refuse randomization to receive PMT will be offered to participate in the observational group. These participants proceed with the same baseline and follow-up testing, but continue with their treatment-of-choice rather than an assigned treatment during the 3-week intervention period.
All participants will complete baseline and follow-up biomechanical and clinical follow-up testing in the Motion Analysis and Performance Laboratory. Biomechanical testing involves using 3-dimensional motion capture techniques to analyze movement during 3 functional tasks including walking, sit-to-stand, and a forward tap-down. Clinical testing involves obtaining anthropometric measures, hip strength, patient-reported function, and planned treatment decisions with respective expected outcomes. A small sub-group of patients will also complete interviews at these testing sessions to identify how they feel about the intervention (wait or posture & movement training).
Posture and movement training involves the physical therapist prescribing therapeutic exercises and activities to improve posture and movement (Harris-Hayes 2016), focusing heavily on extrinsic cueing (Benjaminse 2015). Therapeutic exercises and activities will be individualized based on the participant's presentation and will progress according to pain and quality of movement from double-leg to single-leg activities and from functional to more dynamic tasks.
Participants who are randomized to undergo a 3-week wait period will be required to withhold any treatment during the 3-week wait period. These participants will complete the same testing as the participants in the PMT group (see next paragraph). These participants will not receive any intervention during the 3-week wait period; however, after their first follow-up testing session (within 1 week of completing the 3-week wait period), these participants may proceed with any intervention of their choice. The participants in the PMT group may also proceed with any intervention after their first follow-up testing session. These follow-up interventions will not be provided or required as part of the research study, but participants will be asked to report if they completed any follow-up interventions between their first follow-up testing session and their 3month and 6month follow-up testing sessions.
Follow-up testing will occur within 1-week of completing the 3-week intervention period. At this point, participants in both the PMT and no-PMT groups may proceed with any intervention (i.e. surgery, injection, physical therapy). All participants will perform additional follow-up testing at 3- and 6-months post-intervention.
Qualitative interviews will be conducted to evaluate how physicians and physical therapists involved in the study feel about the evaluation and treatment protocols.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Ohio
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Columbus, Ohio, United States, 43202
- The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Over 18 years old NAHD diagnosis
Exclusion Criteria:
- Osteoporosis or rheumatoid arthritis
- Systemic health condition
- Legal representative required for treatment decisions
- Bilateral symptoms
- Current spine, hip, knee, or ankle surgery or major injury*
- Pregnancy
- Total hip arthroplasty candidate (Tönnis grade > 2)
Periacetabular osteotomy candidate (lateral center edge angle<20, anterior center edge angle<18, acetabular index >10)
- Participants with history of spine, hip, knee, or ankle surgery or major injury will be evaluated by the physician to determine appropriateness for evaluation (and treatment) by a physical therapist
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interdisciplinary Evaluation
Participants will receive an Interdisciplinary Evaluation for Nonarthritic Hip Disease from a hip arthroscopist, followed by an examination from a physical therapist, and then will participate in a shared decision-making process with both providers to determine a plan of care.
|
The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination.
The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking.
After providers discuss their findings, they will discuss the plan of care with the participant.
|
No Intervention: Standard Evaluation
Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant.
|
|
Experimental: Posture and Movement Training
Participants will receive six training sessions with a physical therapist over a 3-week period.
|
Physical therapists will lead participants through an intervention protocol to normalize seated and standing posture and function movement.
Verbal, visual, and tactile cues, along with strengthening exercises will be provided to train posture and movement.
Other Names:
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No Intervention: 3-week Wait Period
Participants will undergo a 3-week wait period.
They will be instructed to not receive any treatment (e.g.
chiropractic services, physical therapy, medication, surgery, injections) for their hip symptoms during this time.
|
|
Other: Observational Arm
Participants who refuse randomization to receive posture and movement training may continue participation in an observational group.
These participants complete the same baseline and follow-up testing but proceed with their treatment-of-choice during the 3-week intervention period.
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Participants may proceed with any treatment-of-choice, which may or may not have been recommended by their health care provider(s).
Treatments will be recorded, but not controlled.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Plan
Time Frame: Post-evaluation, same-day (approximately 5-10min after evaluation)
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Participants will indicate their planned treatment(s)
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Post-evaluation, same-day (approximately 5-10min after evaluation)
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Decisional Conflict
Time Frame: Pre-evaluation, 10min Post-evaluation
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Participants will report decisional conflict related to their treatment plan.
Decisional conflict was measured using the Decisional Conflict Scale ranging from 0 (no conflict, better outcome) to 100 (high conflict, worse outcome).
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Pre-evaluation, 10min Post-evaluation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Themes From Provider Interviews
Time Frame: Pre-enrollment (2-7days before patient participant recruitment began), Post-enrollment (1-7 days after patient participant recruitment ended)
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Qualitative interviews will be conducted with study providers both before patient participant enrollment and after study completion to collect information on how they feel about the evaluation protocols.
Qualitative analysis of this data will count responses based on themes.
Data for this report will be provided as the total number of responses (across all providers) that fell within each theme at both time points.
Each provider could provide multiple responses.
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Pre-enrollment (2-7days before patient participant recruitment began), Post-enrollment (1-7 days after patient participant recruitment ended)
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Participant Protocol Opinions
Time Frame: 20min post-evaluation, 4 weeks post-evaluation
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Participants will be interviewed to collect information on how they feel about the 1) evaluation protocol(s) and 2) treatment/wait period protocols.
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20min post-evaluation, 4 weeks post-evaluation
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Decisional Conflict
Time Frame: 10min post-evaluation, 4-week laboratory visit
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Participants will report decisional conflict related to their treatment plan.
Decisional conflict was measured using the Decisional Conflict Scale ranging from 0 (no conflict, better outcome) to 100 (high conflict, worse outcome).
Baseline scores for participants in Period 3 (Laboratory testing) were obtained from participants' post-evaluation surveys from Period 1 (clinic evaluation).
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10min post-evaluation, 4-week laboratory visit
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Patient-reported Hip Function
Time Frame: 10min post-evaluation, 4-week laboratory visit
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Participants will complete validated, reliable surveys for hip function (the Hip Outcome Score Activities of Daily Living [HOSADL] was used and is scored from 0-100 with 0 representing the worst function and 100 representing the best function).
Baseline scores for participants in Period 3 (Laboratory testing) were obtained from participants' post-evaluation surveys from Period 1 (clinic evaluation).
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10min post-evaluation, 4-week laboratory visit
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Movement Mechanics
Time Frame: Baseline laboratory visit, 4-week laboratory visit
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3-dimensional movement mechanics will be collected during functional tasks including walking and rising from a chair
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Baseline laboratory visit, 4-week laboratory visit
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decisional Regret
Time Frame: Day of enrollment, after all evaluations are complete
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Participants will report decision regret related to their treatment plans
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Day of enrollment, after all evaluations are complete
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Decisional Regret
Time Frame: 4 weeks
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Participants will report decision regret related to their treatment plans
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4 weeks
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Changes in Hip Strength
Time Frame: 4 weeks
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Strength of hip abductors, adductors, flexors, extenders, internal and external rotators will be collected during maximal voluntary isometric contractions
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephanie Di Stasi, PhD, PT, Ohio State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2017H0340
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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