Clinical trial NCT03519087: Nonarthritic Hip Disease Evaluation And Treatment
Official title: Informed Decisions and Patient Outcomes: An Interdisciplinary Approach to Chronic Hip Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Clinical Decision Making
Nonarthritic Hip Disease
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Foundation for Physical Therapy, Inc.
name: Washington University School of Medicine
First posted: 2018-05-08
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to understand how interdisciplinary care influences decisions, expectations, and outcomes for patients with non-arthritic hip disease (NAHD). Patients presenting to the Ohio State University Wexner Medical Center (OSUWMC) Hip Preservation Clinic will be approached for participation. All participants will proceed with their scheduled, standard-care physician evaluation. Participants without NAHD will be excluded. Participants will then be randomized to receive a same-day physical therapist (PT) evaluation. This PT evaluation is not a standard-care practice in the clinic, this was added for research. All participants will complete expectation surveys before and after their evaluation(s). The clinicians will discuss their recommended plan with the patient and the patient will record a final treatment decision and outcome expectations. Participants will then be randomized to either receive posture and movement training (PMT) for 3 weeks or undergo a 3-week wait period. All participants will be required to withhold any treatment during this 3-week period (except PMT in the PMT group). The 3-week wait period for the no-PMT group is aligned with current clinical processes for time from physician evaluation to start of treatment. All participants may proceed with any further interventions (including PMT) after the 3-week period, but none will be provided/required as part of research. Patient-reported outcomes and clinical tests will be recorded before and after the 3-week period, and 3 and 6 months later. Adding a PT evaluation to the physician visit provides no additional risk because the PT evaluation includes similar clinical tests to the physician and movement analysis during tasks participants complete during daily life. Clinical tests before/after the 3-week intervention period may produce muscle soreness that should resolve within 2 days. Understanding how interdisciplinary care influences expectations and outcomes can inform clinicians regarding the effectiveness of interdisciplinary collaboration.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment Plan
timeFrame: Post-evaluation, same-day (approximately 5-10min after evaluation)
measure: Decisional Conflict
timeFrame: Pre-evaluation, 10min Post-evaluation
Secondary outcomes:
measure: Themes From Provider Interviews
timeFrame: Pre-enrollment (2-7days before patient participant recruitment began), Post-enrollment (1-7 days after patient participant recruitment ended)
measure: Participant Protocol Opinions
timeFrame: 20min post-evaluation, 4 weeks post-evaluation
measure: Decisional Conflict
timeFrame: 10min post-evaluation, 4-week laboratory visit
measure: Patient-reported Hip Function
timeFrame: 10min post-evaluation, 4-week laboratory visit
measure: Movement Mechanics
timeFrame: Baseline laboratory visit, 4-week laboratory visit
Other outcomes:
measure: Decisional Regret
timeFrame: Day of enrollment, after all evaluations are complete
measure: Decisional Regret
timeFrame: 4 weeks
measure: Changes in Hip Strength
timeFrame: 4 weeks
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute
state: Ohio
Study officials:
affiliation: Ohio State University
name: Stephanie Di Stasi, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: