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出境医 / 临床实验 / Comparison of Movement Pattern Training and Manual Therapy for Prearthritic Hip Disorders

Comparison of Movement Pattern Training and Manual Therapy for Prearthritic Hip Disorders

Study Description
Brief Summary:

Specific Aims Significance: Intra-articular, prearthritic hip disorders (PAHD) result in substantial dysfunction in young adults and are proposed precursors to hip osteoarthritis (OA). Our long term goal is to develop effective treatment strategies for people with PAHD that will improve function, decrease pain and prevent or delay the onset of OA. The purpose of this study is to compare movement pattern training (MoveTrain) and manual therapy (ManTher) in their effect on post-treatment, patient-reported outcomes and targeted impairments thought to contribute to PAHD.

Innovation: A clear need exists to rigorously assess treatment strategies for PAHD, therefore we propose to assess the effect of two rehabilitation strategies that target two distinct mechanisms. MoveTrain is designed to reduce stresses on the hip joint by optimizing the biomechanics of functional tasks through task-specific instruction. Previously, we demonstrated that MoveTrain resulted in improvement in patient-reported outcomes, however comparison to other approaches is needed. ManTher is believed to impart a neurophysiological response within the peripheral and central nervous system that reduces pain and improves mobility. While ManTher has been shown to be effective in reducing pain in patients with hip OA, little has been reported in PAHD. This study will address APTA's Research Agenda item II. "to determine effectiveness and efficacy of interventions provided by physical therapists across relevant domains of health" and item II.16, "to identify contextual factors (e.g. personal and environmental) that affect prognosis".

This pilot study will collect sufficient data to power a future study that will determine the efficacy of MoveTrain compared to ManTher for people with PAHD. Participants with PAHD will be randomized into one of two treatment groups, MoveTrain or ManTher. The Hip disability and Osteoarthritis Outcome Score (HOOS)68 will be the primary outcome measure. A measure of hip adduction motion during functional tasks and quantitative sensory assessment (pain pressure threshold and temporal summation) will be the secondary measures used to assess the effect of respective treatment on the impairments thought to contribute to PAHD, thus addressing the mechanisms of pain. Upon completion of this study, we will be positioned to implement a large RCT (randomized clinical trial) to definitively assess the efficacy of MoveTrain and ManTher to improve PAHD.

Specific Aims: To obtain preliminary estimates of effect sizes for planning the future definitive randomized clinical trial,

Aim 1 (Function): we will compare post-treatment improvements in hip-specific, patient-reported outcomes among the two treatment groups. After treatment completion:

H1.1: both groups will show improvements in outcomes, but the MoveTrain group will demonstrate greater improvement in function (HOOS Activities of Daily Living) and symptoms (HOOS Symptoms) compared to the ManTher group.

Aim 2 (Mechanism): we will compare pre- and post-treatment measures in lower extremity movement patterns during functional tasks (MoveTrain) and quantitative sensory testing (ManTher). After treatment completion:

H2.1: the MoveTrain group will demonstrate a greater reduction in peak hip adduction angle during functional tasks compared to ManTher.

H2.2: the ManTher group will demonstrate a greater increase in pain pressure threshold (improvement) and greater decrease in temporal summation (improvement) compared to MoveTrain.

Aim 3 (Prognosis): we will determine the association among personal factors at baseline (demographic and psychosocial) and treatment prognosis (improvement in HOOS).

H3.1: High BMI, depressive symptoms (PROMIS depression score) and more severe symptoms linked to central sensitization (Central Sensitization Index) will be associated with less improvement in HOOS after treatment.

Impact: The lack of evidence related to rehabilitation for those with PAHD leads to heterogeneous rehabilitation programs that are difficult to study and compare. Our line of research will improve our understanding of each proposed treatment and its effect on patient function and each treatment's targeted impairment. This improved understanding will lead to the development of treatment strategies that will ultimately result in comparative effectiveness studies of surgical and non-surgical treatment.


Condition or disease Intervention/treatment Phase
Hip-related Groin Pain Femoroacetabular Impingement Dysplasia Mild Prearthritic Hip Disorder Other: Movement Pattern Training Other: Manual Therapy Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will complete self-report questionnaires and participate in a clinical examination that will include movement pattern, range of motion and quantitative sensory assessment. Participants will be randomized into one of two treatment groups, movement pattern training (MoveTrain) or manual therapy (ManTher). Both groups will participate in 10 supervised sessions within a 12 week time frame. MoveTrain will include task-specific training to optimize biomechanics during daily tasks and patient-specific tasks including work and fitness. ManTher will include select manual techniques including joint and soft tissue mobilization. Both groups will receive a home exercise program. At 13 weeks after enrollment, participants will return for testing to assess post-treatment improvements in primary and secondary outcomes. We also obtain 6 and 12 month questionnaires to assess patient outcomes.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The principle investigator and research staff who will be completing outcome assessments and measurements will be blinded to treatment group. Given the nature of the treatment, it is not possible to blind the care provider or the participant from the treatment group.
Primary Purpose: Treatment
Official Title: Comparison of Movement Pattern Training and Manual Therapy for Prearthritic Hip Disorders: a Pilot Randomized Clinical Trial
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Movement Pattern Training
Focus will be on task-specific training to improve lower extremity movement patterns during basic daily tasks, such as sit to stand and stairs, and reported patient-specific tasks. Patient education will include instruction in abnormal movement patterns and methods to optimize movement patterns during each task. Tasks will be prioritized based on patient-report of activity limitations during the baseline examination. For example, during the first visit, the treating physical therapist will begin with the daily and patient-specific tasks that the patient reported as being most bothersome. Exercises will include repeated practice of functional tasks using optimized movement patterns. Based on the participant's performance, the difficulty of the task-specific activities will be progressed by varying the repetitions performed, increasing the load or changing the support surface. The home program will consist of repeated practice of tasks performed during the supervised sessions.
 Other: Movement Pattern Training
Treatment will include 10 supervised sessions over 12 weeks and instruction in a home exercise program After randomization, participants will be scheduled with a physical therapist trained in standard procedures. Treatment will include assessment of patient goals, patient education and instruction in a home program. Patient education will focus on patient-specific tasks, identified by the participant to be symptom-producing.
Active Comparator: Manual Therapy (Joint Mobilization)
Focus will be on reducing pain and improving pain-free range of motion using manual techniques provided by the physical therapist and exercise performed in the home program. Patient education will include instruction to the benefits of manual therapy and the proposed effects on pain and joint mobility. Joint mobilizations to be used with each patient will be prioritized based on the restrictions, defined as stiffness or pain that is limiting joint range of motion, noted on the patient's baseline examination. For example, during the first visit, the treating physical therapist will begin with the two most restricted motions noted in the baseline exam and perform a standard assessment to determine treatment parameters. The home program will include joint range of motion and stretching exercises to complement techniques performed during the supervised sessions.
 Other: Manual Therapy
Treatment will include 10 supervised sessions over 12 weeks and instruction in a home exercise program After randomization, participants will be scheduled with a physical therapist trained in standard procedures. Treatment will include assessment of patient goals, patient education and instruction in a home program. Patient education will focus on patient-specific tasks, identified by the participant to be symptom-producing.
Other Name: Joint Mobilization
Outcome Measures
Primary Outcome Measures :
  1. Hip disability and Osteoarthritis Outcome Score Activities of Daily Living Subscale [ Time Frame: 13 weeks ]
    The Hip disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.

  2. Hip disability and Osteoarthritis Outcome Score Symptom Subscale [ Time Frame: 13 weeks ]
    The Hip disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.


Secondary Outcome Measures :
  1. Hip adduction angle [ Time Frame: 13 weeks ]
    Variable to assess movement pattern changes.

  2. Pain pressure threshold [ Time Frame: 13 weeks ]
    quantitative sensory testing to assess the patient's sensitivity to stimuli


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-40 years

    • Must be scheduled before their 40th birthday
  • Have frequent hip joint symptoms, defined as pain, aching or stiffness within the hip joint for at least 3 months during the past 12 months
  • Hip joint pain confirmed upon physical exam
  • Report pain >= 3/10
  • Reports functional limitation as demonstrated by modified Harris Hip Score <90
  • Has protective sensation in the feet

Exclusion Criteria:

  • Previous hip surgery, fracture, pelvic/hip infection or cancer
  • Pain due to high impact trauma
  • Inflammatory disease, e.g. rheumatoid arthritis, gout
  • Acute pain in another joint that limits functional activities
  • Perthes disease or slipped capital femoral epiphysis
  • Hip pain referred from another source, e.g. lumbar spine
  • Neurological involvement affecting balance or coordination
  • Use of assistive gait device for more than 50% of time walking
  • Pain, numbness or tingling in the lower extremity
  • Pregnancy or given birth in previous 12 weeks
  • Unwilling to refrain from taking NSAIDs 1-2 days prior to testing session
  • Unable to attend regular physical therapy sessions
  • Unable to complete 12 month follow up session - Avascular Necrosis
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Martha Hessler, BS 314-286-1478 mjhessler@wustl.edu
Contact: Marcie Harris-Hayes, DPT, MSCI 314-286-1435 harrisma@wustl.edu

Locations
Layout table for location information
United States, Missouri
Program in Physical Therapy, Washington University Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Martha Hessler, BS    314-286-1478    mjhessler@wustl.edu   
Contact: Marcie Harris-Hayes, DPT, MSCI    314-286-1435    harrisma@wustl.edu   
Principal Investigator: Marcie Harris-Hayes, DPT, MSCI         
Sponsors and Collaborators
Washington University School of Medicine
Foundation for Physical Therapy, Inc.
Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 19, 2021
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • Hip disability and Osteoarthritis Outcome Score Activities of Daily Living Subscale [ Time Frame: 13 weeks ]
    The Hip disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.
  • Hip disability and Osteoarthritis Outcome Score Symptom Subscale [ Time Frame: 13 weeks ]
    The Hip disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Hip disability and Osteoarthritis Outcome Score Activities of Daily Living Subscale [ Time Frame: 13 weeks ]
    Hip-specific Patient-Reported Outcome measure
  • Hip disability and Osteoarthritis Outcome Score Symptom Subscale [ Time Frame: 13 weeks ]
    Hip-specific Patient-Reported Outcome measure
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Hip adduction angle [ Time Frame: 13 weeks ]
    Variable to assess movement pattern changes.
  • Pain pressure threshold [ Time Frame: 13 weeks ]
    quantitative sensory testing to assess the patient's sensitivity to stimuli
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Movement Pattern Training and Manual Therapy for Prearthritic Hip Disorders
Official Title  ICMJE Comparison of Movement Pattern Training and Manual Therapy for Prearthritic Hip Disorders: a Pilot Randomized Clinical Trial
Brief Summary

Specific Aims Significance: Intra-articular, prearthritic hip disorders (PAHD) result in substantial dysfunction in young adults and are proposed precursors to hip osteoarthritis (OA). Our long term goal is to develop effective treatment strategies for people with PAHD that will improve function, decrease pain and prevent or delay the onset of OA. The purpose of this study is to compare movement pattern training (MoveTrain) and manual therapy (ManTher) in their effect on post-treatment, patient-reported outcomes and targeted impairments thought to contribute to PAHD.

Innovation: A clear need exists to rigorously assess treatment strategies for PAHD, therefore we propose to assess the effect of two rehabilitation strategies that target two distinct mechanisms. MoveTrain is designed to reduce stresses on the hip joint by optimizing the biomechanics of functional tasks through task-specific instruction. Previously, we demonstrated that MoveTrain resulted in improvement in patient-reported outcomes, however comparison to other approaches is needed. ManTher is believed to impart a neurophysiological response within the peripheral and central nervous system that reduces pain and improves mobility. While ManTher has been shown to be effective in reducing pain in patients with hip OA, little has been reported in PAHD. This study will address APTA's Research Agenda item II. "to determine effectiveness and efficacy of interventions provided by physical therapists across relevant domains of health" and item II.16, "to identify contextual factors (e.g. personal and environmental) that affect prognosis".

This pilot study will collect sufficient data to power a future study that will determine the efficacy of MoveTrain compared to ManTher for people with PAHD. Participants with PAHD will be randomized into one of two treatment groups, MoveTrain or ManTher. The Hip disability and Osteoarthritis Outcome Score (HOOS)68 will be the primary outcome measure. A measure of hip adduction motion during functional tasks and quantitative sensory assessment (pain pressure threshold and temporal summation) will be the secondary measures used to assess the effect of respective treatment on the impairments thought to contribute to PAHD, thus addressing the mechanisms of pain. Upon completion of this study, we will be positioned to implement a large RCT (randomized clinical trial) to definitively assess the efficacy of MoveTrain and ManTher to improve PAHD.

Specific Aims: To obtain preliminary estimates of effect sizes for planning the future definitive randomized clinical trial,

Aim 1 (Function): we will compare post-treatment improvements in hip-specific, patient-reported outcomes among the two treatment groups. After treatment completion:

H1.1: both groups will show improvements in outcomes, but the MoveTrain group will demonstrate greater improvement in function (HOOS Activities of Daily Living) and symptoms (HOOS Symptoms) compared to the ManTher group.

Aim 2 (Mechanism): we will compare pre- and post-treatment measures in lower extremity movement patterns during functional tasks (MoveTrain) and quantitative sensory testing (ManTher). After treatment completion:

H2.1: the MoveTrain group will demonstrate a greater reduction in peak hip adduction angle during functional tasks compared to ManTher.

H2.2: the ManTher group will demonstrate a greater increase in pain pressure threshold (improvement) and greater decrease in temporal summation (improvement) compared to MoveTrain.

Aim 3 (Prognosis): we will determine the association among personal factors at baseline (demographic and psychosocial) and treatment prognosis (improvement in HOOS).

H3.1: High BMI, depressive symptoms (PROMIS depression score) and more severe symptoms linked to central sensitization (Central Sensitization Index) will be associated with less improvement in HOOS after treatment.

Impact: The lack of evidence related to rehabilitation for those with PAHD leads to heterogeneous rehabilitation programs that are difficult to study and compare. Our line of research will improve our understanding of each proposed treatment and its effect on patient function and each treatment's targeted impairment. This improved understanding will lead to the development of treatment strategies that will ultimately result in comparative effectiveness studies of surgical and non-surgical treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will complete self-report questionnaires and participate in a clinical examination that will include movement pattern, range of motion and quantitative sensory assessment. Participants will be randomized into one of two treatment groups, movement pattern training (MoveTrain) or manual therapy (ManTher). Both groups will participate in 10 supervised sessions within a 12 week time frame. MoveTrain will include task-specific training to optimize biomechanics during daily tasks and patient-specific tasks including work and fitness. ManTher will include select manual techniques including joint and soft tissue mobilization. Both groups will receive a home exercise program. At 13 weeks after enrollment, participants will return for testing to assess post-treatment improvements in primary and secondary outcomes. We also obtain 6 and 12 month questionnaires to assess patient outcomes.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
The principle investigator and research staff who will be completing outcome assessments and measurements will be blinded to treatment group. Given the nature of the treatment, it is not possible to blind the care provider or the participant from the treatment group.
Primary Purpose: Treatment
Condition  ICMJE
  • Hip-related Groin Pain
  • Femoroacetabular Impingement
  • Dysplasia Mild
  • Prearthritic Hip Disorder
Intervention  ICMJE
  • Other: Movement Pattern Training
    Treatment will include 10 supervised sessions over 12 weeks and instruction in a home exercise program After randomization, participants will be scheduled with a physical therapist trained in standard procedures. Treatment will include assessment of patient goals, patient education and instruction in a home program. Patient education will focus on patient-specific tasks, identified by the participant to be symptom-producing.
  • Other: Manual Therapy
    Treatment will include 10 supervised sessions over 12 weeks and instruction in a home exercise program After randomization, participants will be scheduled with a physical therapist trained in standard procedures. Treatment will include assessment of patient goals, patient education and instruction in a home program. Patient education will focus on patient-specific tasks, identified by the participant to be symptom-producing.
    Other Name: Joint Mobilization
Study Arms  ICMJE
  • Experimental: Movement Pattern Training
    Focus will be on task-specific training to improve lower extremity movement patterns during basic daily tasks, such as sit to stand and stairs, and reported patient-specific tasks. Patient education will include instruction in abnormal movement patterns and methods to optimize movement patterns during each task. Tasks will be prioritized based on patient-report of activity limitations during the baseline examination. For example, during the first visit, the treating physical therapist will begin with the daily and patient-specific tasks that the patient reported as being most bothersome. Exercises will include repeated practice of functional tasks using optimized movement patterns. Based on the participant's performance, the difficulty of the task-specific activities will be progressed by varying the repetitions performed, increasing the load or changing the support surface. The home program will consist of repeated practice of tasks performed during the supervised sessions.
    Intervention: Other: Movement Pattern Training
  • Active Comparator: Manual Therapy (Joint Mobilization)
    Focus will be on reducing pain and improving pain-free range of motion using manual techniques provided by the physical therapist and exercise performed in the home program. Patient education will include instruction to the benefits of manual therapy and the proposed effects on pain and joint mobility. Joint mobilizations to be used with each patient will be prioritized based on the restrictions, defined as stiffness or pain that is limiting joint range of motion, noted on the patient's baseline examination. For example, during the first visit, the treating physical therapist will begin with the two most restricted motions noted in the baseline exam and perform a standard assessment to determine treatment parameters. The home program will include joint range of motion and stretching exercises to complement techniques performed during the supervised sessions.
    Intervention: Other: Manual Therapy
Publications *
  • Abbott JH, Robertson MC, Chapple C, Pinto D, Wright AA, Leon de la Barra S, Baxter GD, Theis JC, Campbell AJ; MOA Trial team. Manual therapy, exercise therapy, or both, in addition to usual care, for osteoarthritis of the hip or knee: a randomized controlled trial. 1: clinical effectiveness. Osteoarthritis Cartilage. 2013 Apr;21(4):525-34. doi: 10.1016/j.joca.2012.12.014. Epub 2013 Jan 8.
  • Borrelli B. The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials. J Public Health Dent. 2011 Winter;71 Suppl 1:S52-63.
  • Chimenti RL, Frey-Law LA, Sluka KA. A Mechanism-Based Approach to Physical Therapist Management of Pain. Phys Ther. 2018 May 1;98(5):302-314. doi: 10.1093/ptj/pzy030. Review.
  • Harris-Hayes M, Czuppon S, Van Dillen LR, Steger-May K, Sahrmann S, Schootman M, Salsich GB, Clohisy JC, Mueller MJ. Movement-Pattern Training to Improve Function in People With Chronic Hip Joint Pain: A Feasibility Randomized Clinical Trial. J Orthop Sports Phys Ther. 2016 Jun;46(6):452-61. doi: 10.2519/jospt.2016.6279. Epub 2016 Apr 26.
  • Harris-Hayes M, Holtzman GW, Earley JA, Van Dillen LR. Development and preliminary reliability testing of an assessment of patient independence in performing a treatment program: standardized scenarios. J Rehabil Med. 2010 Mar;42(3):221-7. doi: 10.2340/16501977-0505.
  • Harris-Hayes M, Mueller MJ, Sahrmann SA, Bloom NJ, Steger-May K, Clohisy JC, Salsich GB. Persons with chronic hip joint pain exhibit reduced hip muscle strength. J Orthop Sports Phys Ther. 2014 Nov;44(11):890-8. doi: 10.2519/jospt.2014.5268. Epub 2014 Oct 9.
  • Harris-Hayes M, Steger-May K, Koh C, Royer NK, Graci V, Salsich GB. Classification of lower extremity movement patterns based on visual assessment: reliability and correlation with 2-dimensional video analysis. J Athl Train. 2014 May-Jun;49(3):304-10. doi: 10.4085/1062-6050-49.2.21.
  • Harris-Hayes M, Steger-May K, van Dillen LR, Schootman M, Salsich GB, Czuppon S, Clohisy JC, Commean PK, Hillen TJ, Sahrmann SA, Mueller MJ. Reduced Hip Adduction Is Associated With Improved Function After Movement-Pattern Training in Young People With Chronic Hip Joint Pain. J Orthop Sports Phys Ther. 2018 Apr;48(4):316-324. doi: 10.2519/jospt.2018.7810. Epub 2018 Mar 16.
  • Hwang CT, Van Dillen LR, Haroutounian S. Do Changes in Sensory Processing Precede Low Back Pain Development in Healthy Individuals? Clin J Pain. 2018 Jun;34(6):525-531. doi: 10.1097/AJP.0000000000000563.
  • Moss P, Sluka K, Wright A. The initial effects of knee joint mobilization on osteoarthritic hyperalgesia. Man Ther. 2007 May;12(2):109-18. Epub 2006 Jun 13.
  • French HP, Cusack T, Brennan A, Caffrey A, Conroy R, Cuddy V, FitzGerald OM, Fitzpatrick M, Gilsenan C, Kane D, O'Connell PG, White B, McCarthy GM. Exercise and manual physiotherapy arthritis research trial (EMPART) for osteoarthritis of the hip: a multicenter randomized controlled trial. Arch Phys Med Rehabil. 2013 Feb;94(2):302-14. doi: 10.1016/j.apmr.2012.09.030. Epub 2012 Oct 16. Erratum in: Arch Phys Med Rehabil. 2013 Mar;94(3):600. Fitzpatrick, Martina [added].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-40 years

    • Must be scheduled before their 40th birthday
  • Have frequent hip joint symptoms, defined as pain, aching or stiffness within the hip joint for at least 3 months during the past 12 months
  • Hip joint pain confirmed upon physical exam
  • Report pain >= 3/10
  • Reports functional limitation as demonstrated by modified Harris Hip Score <90
  • Has protective sensation in the feet

Exclusion Criteria:

  • Previous hip surgery, fracture, pelvic/hip infection or cancer
  • Pain due to high impact trauma
  • Inflammatory disease, e.g. rheumatoid arthritis, gout
  • Acute pain in another joint that limits functional activities
  • Perthes disease or slipped capital femoral epiphysis
  • Hip pain referred from another source, e.g. lumbar spine
  • Neurological involvement affecting balance or coordination
  • Use of assistive gait device for more than 50% of time walking
  • Pain, numbness or tingling in the lower extremity
  • Pregnancy or given birth in previous 12 weeks
  • Unwilling to refrain from taking NSAIDs 1-2 days prior to testing session
  • Unable to attend regular physical therapy sessions
  • Unable to complete 12 month follow up session - Avascular Necrosis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Martha Hessler, BS 314-286-1478 mjhessler@wustl.edu
Contact: Marcie Harris-Hayes, DPT, MSCI 314-286-1435 harrisma@wustl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959319
Other Study ID Numbers  ICMJE 201901005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Foundation for Physical Therapy, Inc.
Investigators  ICMJE Not Provided
PRS Account Washington University School of Medicine
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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