Nonarthritic Hip Disease Evaluation And Treatment

NCT03519087 | Terminated Results

• 1 other identifier: 2017H0340
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Decision Making; Nonarthritic Hip Disease

Outcome Measures

Primary Outcomes (2)

• Treatment Plan

  Participants will indicate their planned treatment(s)

  Post-evaluation, same-day (approximately 5-10min after evaluation)

• Decisional Conflict

  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).

  Pre-evaluation, 10min Post-evaluation

Secondary Outcomes (5)

• Themes From Provider Interviews

  Pre-enrollment (2-7days before patient participant recruitment began), Post-enrollment (1-7 days after patient participant recruitment ended)

• Participant Protocol Opinions

  20min post-evaluation, 4 weeks post-evaluation

• Decisional Conflict

  10min post-evaluation, 4-week laboratory visit

• Patient-reported Hip Function

  10min post-evaluation, 4-week laboratory visit

• Movement Mechanics

  Baseline laboratory visit, 4-week laboratory visit

Other Outcomes (3)

• Decisional Regret

  Day of enrollment, after all evaluations are complete

• Decisional Regret

  4 weeks

• Changes in Hip Strength

  4 weeks

Study Arms (5)

Interdisciplinary Evaluation

EXPERIMENTAL

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.

Other: Interdisciplinary Evaluation for Nonarthritic Hip Disease

Standard Evaluation

NO INTERVENTION

Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant.

Posture and Movement Training

EXPERIMENTAL

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

Other: Posture and Movement Training

3-week Wait Period

NO INTERVENTION

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.

Observational Arm

OTHER

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.

Other: Treatment-of-choice

Interventions

Interdisciplinary Evaluation for Nonarthritic Hip Disease 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.

Interdisciplinary Evaluation

Posture and Movement Training 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.

Also known as: Movement Pattern Training

Posture and Movement Training

Treatment-of-choice 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.

Also known as: Standard care

Observational Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old NAHD diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• Foundation for Physical Therapy, Inc.: collaborator
• Washington University School of Medicine: collaborator

Study Sites (1)

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

Columbus, Ohio, 43202, United States

Location

MeSH Terms

Interventions

Posture; Standard of Care

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Seventy-eight (78) participants were included from the 15-month recruitment period (81% of the target n=96). Randomization for interdisciplinary vs. standard evaluation had to occur before physician evaluation, modified from the original protocol.

Results Point of Contact

• Title: Dr. Stephanie Di Stasi
• Organization: The Ohio State University

stephanie.distasi@osumc.edu

614-685-9779

Study Officials

• Stephanie Di Stasi, PhD, PT

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: May 8, 2018
• Study Start: February 27, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: May 6, 2020
• Results First Posted: May 6, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)