Nonarthritic Hip Disease Evaluation And Treatment

NCT ID: NCT03519087

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2019-05-31

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.

Conditions

Clinical Decision Making; Nonarthritic Hip Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Interdisciplinary Evaluation for Nonarthritic Hip Disease

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Posture and Movement Training

Participants will receive six training sessions with a physical therapist over a 3-week period.

Group Type: EXPERIMENTAL

Posture and Movement Training

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: OTHER

Treatment-of-choice

Intervention Type: OTHER

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.

Interventions

Interdisciplinary Evaluation for Nonarthritic Hip Disease

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.

Intervention Type: OTHER

Posture and Movement Training

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.

Intervention Type: OTHER

Treatment-of-choice

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.

Intervention Type: OTHER

Other Intervention Names

Movement Pattern Training; Standard care

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Physical Therapy, Inc.

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Di Stasi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie Di Stasi, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2017H0340

Identifier Type: -

Identifier Source: org_study_id