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Nonarthritic Hip Disease Evaluation And Treatment

Informed Decisions and Patient Outcomes: An Interdisciplinary Approach to Chronic Hip Pain

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03519087
Acronym
NEAT
Enrollment
112
Registered
2018-05-08
Start date
2018-02-27
Completion date
2019-05-31
Last updated
2020-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Decision Making, Nonarthritic Hip Disease

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.

Interventions

OTHERInterdisciplinary 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.

OTHERPosture 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.

OTHERTreatment-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.

Sponsors

Foundation for Physical Therapy, Inc.
CollaboratorINDUSTRY
Washington University School of Medicine
CollaboratorOTHER
Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Decisional ConflictPre-evaluation, 10min Post-evaluationParticipants 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).
Treatment PlanPost-evaluation, same-day (approximately 5-10min after evaluation)Participants will indicate their planned treatment(s)

Secondary

MeasureTime frameDescription
Participant Protocol Opinions20min post-evaluation, 4 weeks post-evaluationParticipants will be interviewed to collect information on how they feel about the 1) evaluation protocol(s) and 2) treatment/wait period protocols.
Patient-reported Hip Function10min post-evaluation, 4-week laboratory visitParticipants 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).
Movement MechanicsBaseline laboratory visit, 4-week laboratory visit3-dimensional movement mechanics will be collected during functional tasks including walking and rising from a chair
Decisional Conflict10min post-evaluation, 4-week laboratory visitParticipants 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).
Themes From Provider InterviewsPre-enrollment (2-7days before patient participant recruitment began), Post-enrollment (1-7 days after patient participant recruitment ended)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.

Other

MeasureTime frameDescription
Decisional RegretDay of enrollment, after all evaluations are completeParticipants will report decision regret related to their treatment plans
Changes in Hip Strength4 weeksStrength of hip abductors, adductors, flexors, extenders, internal and external rotators will be collected during maximal voluntary isometric contractions

Countries

United States

Participant flow

Pre-assignment details

No participants were excluded from the study before assignment to groups (interdisciplinary vs. standard)

Participants by arm

ArmCount
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. 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.
39
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.
39
Total78

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004
Clinic EvaluationPhysician Decision1518000
Clinic EvaluationProtocol Violation10000
Laboratory TestingLost to Follow-up00236
Laboratory TestingProtocol Violation00010
Re-randomization for TreatmentNot appropriate23000
Re-randomization for TreatmentWithdrawal by Subject2529000

Baseline characteristics

CharacteristicInterdisciplinary EvaluationStandard EvaluationTotal
Age, Continuous36 years
STANDARD_DEVIATION 10
41 years
STANDARD_DEVIATION 11
38 years
STANDARD_DEVIATION 11
Decisional Conflict35.0 units on a scale
STANDARD_DEVIATION 19.6
40.1 units on a scale
STANDARD_DEVIATION 18.6
37.6 units on a scale
STANDARD_DEVIATION 19.2
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
6 Participants3 Participants9 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants5 Participants7 Participants
Race (NIH/OMB)
White
28 Participants30 Participants58 Participants
Region of Enrollment
United States
39 participants39 participants78 participants
Sex: Female, Male
Female
28 Participants24 Participants52 Participants
Sex: Female, Male
Male
11 Participants15 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 390 / 39
other
Total, other adverse events
0 / 390 / 39
serious
Total, serious adverse events
0 / 390 / 39

Outcome results

Primary

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).

Time frame: Pre-evaluation, 10min Post-evaluation

Population: Participants from Period 1 (Clinic evaluation) were analyzed for this primary outcome measure based on interdisciplinary or standard evaluation. This outcome measure was not a planned outcome for Period 3 (Laboratory testing) and thus, values are not reported for posture and movement training, 3-week wait period, or observational groups.

ArmMeasureGroupValue (MEAN)Dispersion
Interdisciplinary EvaluationDecisional ConflictPre-evaluation decisional conflict35.0 units on a scaleStandard Deviation 19.6
Interdisciplinary EvaluationDecisional ConflictPost-evaluation decisional conflict10.2 units on a scaleStandard Deviation 11.2
Standard EvaluationDecisional ConflictPost-evaluation decisional conflict16.5 units on a scaleStandard Deviation 13.6
Standard EvaluationDecisional ConflictPre-evaluation decisional conflict40.1 units on a scaleStandard Deviation 18.6
Primary

Treatment Plan

Participants will indicate their planned treatment(s)

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

Population: Participants from Period 1 (Clinic evaluation) were analyzed for this primary outcome measure based on interdisciplinary or standard evaluation. This outcome measure was not a planned outcome for Period 3 (Laboratory testing) and thus, values are not reported for posture and movement training, 3-week wait period, or observational groups.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Interdisciplinary EvaluationTreatment PlanPhysical Therapy included in treatment plan26 Participants
Interdisciplinary EvaluationTreatment PlanSurgery included in treatment plan19 Participants
Interdisciplinary EvaluationTreatment PlanInjection included in treatment plan13 Participants
Standard EvaluationTreatment PlanPhysical Therapy included in treatment plan19 Participants
Standard EvaluationTreatment PlanSurgery included in treatment plan19 Participants
Standard EvaluationTreatment PlanInjection included in treatment plan21 Participants
Secondary

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). Baseline scores for participants in Period 3 (Laboratory testing) were obtained from participants' post-evaluation surveys from Period 1 (clinic evaluation).

Time frame: 10min post-evaluation, 4-week laboratory visit

Population: Participants from Period 3 (Laboratory testing) were analyzed for this secondary outcome measure based on treatment group (Posture \& movement training, wait period, or observational). This outcome measure was not a planned follow-up outcome for Period 1 (Clinic evaluation) and thus, values are not reported for interdisciplinary and standard groups.

ArmMeasureGroupValue (MEAN)Dispersion
Interdisciplinary EvaluationDecisional Conflict4-week decisional conflict14.0 units on a scaleStandard Deviation 16.2
Interdisciplinary EvaluationDecisional ConflictPost-evaluation decisional conflict13.2 units on a scaleStandard Deviation 10.3
Standard EvaluationDecisional ConflictPost-evaluation decisional conflict14.8 units on a scaleStandard Deviation 20.9
Standard EvaluationDecisional Conflict4-week decisional conflict13.2 units on a scaleStandard Deviation 9.9
Posture and Movement TrainingDecisional ConflictPost-evaluation decisional conflict0 units on a scaleStandard Deviation 0
Posture and Movement TrainingDecisional Conflict4-week decisional conflict0.0 units on a scaleStandard Deviation 0
Secondary

Movement Mechanics

3-dimensional movement mechanics will be collected during functional tasks including walking and rising from a chair

Time frame: Baseline laboratory visit, 4-week laboratory visit

Population: Movement mechanics were not a planned variable for Period 1 (Clinic evaluation), but were a planned secondary variable for Period 3 (Laboratory testing). Collected data for the 7 participants who completed 4-week testing required extensive processing and resources that were not available due to loss of funding and personnel.

Secondary

Participant Protocol Opinions

Participants will be interviewed to collect information on how they feel about the 1) evaluation protocol(s) and 2) treatment/wait period protocols.

Time frame: 20min post-evaluation, 4 weeks post-evaluation

Population: Data were not collected.

Secondary

Patient-reported Hip Function

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).

Time frame: 10min post-evaluation, 4-week laboratory visit

Population: Participants from Period 3 (Laboratory testing) were analyzed for this secondary outcome measure based on treatment group (Posture \& movement training, wait period, or observational). This outcome measure was not a planned follow-up outcome for Period 1 (Clinic evaluation) and thus, values are not reported for interdisciplinary and standard groups.

ArmMeasureGroupValue (MEAN)Dispersion
Interdisciplinary EvaluationPatient-reported Hip FunctionPost-evaluation HOSADL52.9 units on a scaleStandard Deviation 21.7
Interdisciplinary EvaluationPatient-reported Hip Function4-week HOSADL68.2 units on a scaleStandard Deviation 20
Standard EvaluationPatient-reported Hip FunctionPost-evaluation HOSADL72.6 units on a scaleStandard Deviation 29.8
Standard EvaluationPatient-reported Hip Function4-week HOSADL77.2 units on a scaleStandard Deviation 25.9
Posture and Movement TrainingPatient-reported Hip FunctionPost-evaluation HOSADL89.0 units on a scaleStandard Deviation 0
Posture and Movement TrainingPatient-reported Hip Function4-week HOSADL92.6 units on a scaleStandard Deviation 0
Secondary

Themes From Provider Interviews

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.

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

Population: The orthopaedic surgeons (n=2) and one physical therapist (n=1) from the study were interviewed and number of responses during the interviews were totaled based on theme. Each provider could have multiple responses. These providers are not associated with a specific arm or group of patient participants.

ArmMeasureGroupValue (NUMBER)
Interdisciplinary EvaluationThemes From Provider InterviewsImplementation11 number of responses for each theme
Interdisciplinary EvaluationThemes From Provider InterviewsInterdisciplinary Evaluation10 number of responses for each theme
Interdisciplinary EvaluationThemes From Provider InterviewsEnvironment2 number of responses for each theme
Interdisciplinary EvaluationThemes From Provider InterviewsTime6 number of responses for each theme
Interdisciplinary EvaluationThemes From Provider InterviewsPatient Response12 number of responses for each theme
Interdisciplinary EvaluationThemes From Provider InterviewsClinical Reasoning7 number of responses for each theme
Standard EvaluationThemes From Provider InterviewsPatient Response11 number of responses for each theme
Standard EvaluationThemes From Provider InterviewsImplementation13 number of responses for each theme
Standard EvaluationThemes From Provider InterviewsTime8 number of responses for each theme
Standard EvaluationThemes From Provider InterviewsInterdisciplinary Evaluation13 number of responses for each theme
Standard EvaluationThemes From Provider InterviewsClinical Reasoning9 number of responses for each theme
Standard EvaluationThemes From Provider InterviewsEnvironment5 number of responses for each theme
Other Pre-specified

Changes in Hip Strength

Strength of hip abductors, adductors, flexors, extenders, internal and external rotators will be collected during maximal voluntary isometric contractions

Time frame: 4 weeks

Other Pre-specified

Decisional Regret

Participants will report decision regret related to their treatment plans

Time frame: Day of enrollment, after all evaluations are complete

Other Pre-specified

Decisional Regret

Participants will report decision regret related to their treatment plans

Time frame: 4 weeks

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026