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

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ClinicalTrials.gov Identifier: NCT03959319
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
Foundation for Physical Therapy, Inc.
Information provided by (Responsible Party):
Washington University School of Medicine

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 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

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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

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959319


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

Locations
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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.

Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03959319     History of Changes
Other Study ID Numbers: 201901005
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
clinical trial
rehabilitation
joint mobilization
movement training
Additional relevant MeSH terms:
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Femoracetabular Impingement
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases