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NCT02913222 Clinical Trial

Movement Pattern Training in People With Intra-articular, Prearthritic Hip Disorders

Chronic Hip Joint Pain Clinical Trial

Official title:
Movement Pattern Training in People With Intra-articular, Prearthritic Hip Disorders

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02913222
Other study ID # R21HD086644-01A1-201609106
Secondary ID R21HD086644-01A1
Status Completed
Phase N/A
First received
Last updated
Start date February 4, 2017
Est. completion date December 31, 2019

Study information
Verified date March 2023
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Intra-articular, prearthritic hip disorders (PAHD) result in substantial dysfunction in young adults and are proposed precursors to hip osteoarthritis (OA). Effective treatment of PAHD is needed to improve function in the young adult and prevent or delay the onset of hip OA, however evidence related to treatment of PAHD is limited. This research will provide the foundation for a future clinical trial to assess the efficacy of movement pattern training, an innovative rehabilitation approach for the treatment of PAHD.

Description:

Significance: Intra-articular, prearthritic hip disorders (PAHD) result in substantial dysfunction in young adults and are proposed precursors to hip osteoarthritis. The number of surgical procedures to treat PAHD has grown exponentially in the past decade, despite the lack of high level evidence to guide treatment decisions. The potential exists for surgery to become standard treatment before rigorous investigation of treatment options has been completed. This trend may be partially due to a lack of evidence related to rehabilitation. Although some authors believe rehabilitation can improve function in people with PAHD, others state that rehabilitation is contra-indicated and recommend surgery as the best option. There are no published clinical trials to support or refute either opinion, therefore little is known about the comparative effectiveness of rehabilitation. Innovation: The investigators' long term goal is to develop effective treatment strategies for people with PAHD that will improve function and prevent or delay the onset of OA. Movement pattern training is an innovative rehabilitation approach designed to reduce stresses on the hip joint by optimizing the biomechanics of functional tasks through task-specific instruction. Preliminary work suggests that abnormal movement patterns may be associated with PAHD and that movement pattern training may be an effective treatment approach, however comparison to standard rehabilitation has not been completed. Purpose: This study was designed to assess the feasibility of conducting a multicenter randomized clinical trial (RCT) to determine the efficacy of movement pattern training compared to standard rehabilitation for people with PAHD. Participants enrolled at Washington University and University of Pittsburgh will be randomized into one of two treatment groups, movement pattern training or standard rehabilitation. In addition to assessing feasibility of the trial, preliminary estimates of effect sizes for treatment outcomes will be obtain in preparation for the future definitive trial. Post-treatment improvements in patient-reported function as measured by the Hip disability and Osteoarthritis Outcome Score and hip adduction motion during functional tasks, a proposed mechanistic factor associated with PAHD will be assessed. Upon completion of this study, the investigators will be positioned to implement a multicenter RCT to definitively assess the efficacy of movement pattern training. Impact: Ultimately, if movement pattern training is determined to be effective, it will provide a relatively inexpensive alternative to surgical intervention. Further, the theoretical concepts of movement pattern training could be used to possibly serve a role in injury prevention, as well as optimize post-surgical outcomes in those who do require surgery.

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date December 31, 2019
Est. primary completion date December 12, 2018
Accepts healthy volunteers No
Gender All
Age group 15 Years to 40 Years
Eligibility Inclusion Criteria: - be 15-40 years old - report deep hip joint or anterior groin pain, confirmed upon physical exam - report pain > 3/10 and present > 3 months - demonstrate functional limitation with modified Harris Hip Score <90. Exclusion Criteria: - previous hip surgery, fracture, pelvic/hip infection - pain due to high impact trauma - inflammatory disease, e.g. rheumatoid arthritis, gout - neurological involvement affecting balance - age <15 or >40 - Slipped Capital Femoral Epiphysis (SCFE) or Legg-Calve-Perthes Disease (LCP) - pain, numbness or tingling that radiates into the thigh - known pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Rehabilitation
Comparison of two rehabilitation approaches

Locations
Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania
United States Program in Physical Therapy, Washington University Saint Louis Missouri

Sponsors (3)
Lead Sponsor Collaborator
Washington University School of Medicine Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (5)

Foster SN, Harris MD, Hastings MK, Mueller MJ, Salsich GB, Harris-Hayes M. Static Ankle Dorsiflexion and Hip and Pelvis Kinematics During Forward Step-Down in Patients With Hip-Related Groin Pain. J Sport Rehabil. 2020 Dec 8;30(4):638-645. doi: 10.1123/jsr.2020-0140. — View Citation

Harris-Hayes M, Steger-May K, Bove A, Foster S, Mueller MJ, Clohisy JC, Fitzgerald GK. Sustained Outcomes Following Movement Pattern Training or Strengthening/Flexibility Among Patients with Prearthritic Hip Disorders: Results of a Pilot Multicenter Randomized Clinical Trial. Accepted for OARSI World Congress on Osteoarthritis, April 2020.

Harris-Hayes M, Steger-May K, Bove AM, Foster SN, Mueller MJ, Clohisy JC, Fitzgerald GK. Movement pattern training compared with standard strengthening and flexibility among patients with hip-related groin pain: results of a pilot multicentre randomised c — View Citation

Harris-Hayes M, Steger-May K, M Bove A, Mueller MJ, Clohisy JC, Fitzgerald GK. One-year outcomes following physical therapist-led intervention for chronic hip-related groin pain: Ancillary analysis of a pilot multicenter randomized clinical trial. J Ortho — View Citation

Koch K, Semciw AI, Commean PK, Hillen TJ, Fitzgerald GK, Clohisy JC, Harris-Hayes M. Comparison between movement pattern training and strengthening on muscle volume, muscle fat, and strength in patients with hip-related groin pain: An exploratory analysis — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Pain Subscale From Baseline to Post-treatment (13 Weeks) The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Pain subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOS Pain from the post-treatment HOOS Pain. Between Baseline and Immediately after treatment (13 weeks after baseline)
Other Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Sport Subscale From Baseline to Post-treatment (13 Weeks) The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Sport subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOS Sport from the post-treatment HOOS Sport. Between Baseline and Immediately after treatment (13 weeks after baseline)
Other Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Quality of Life (QOL) Subscale From Baseline to Post-treatment (13 Weeks) The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Quality of Life subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOS Quality of Life from the post-treatment HOOS Quality of Life. Between Baseline and Immediately after treatment (13 weeks after baseline)
Other Change in Function Using the Patient Specific Functional Scale From Baseline to Post-treatment (13 Weeks) The Patient Specific Functional Scale (PSFS), a patient-reported outcome measure of patient-specific activity limitations. Patients are asked to identify "3-5 activities you are unable to do or having difficulties performing due to the pain or symptoms in your hip". Patients then rated level of difficulty from 0-10, 0 indicating they are unable to perform the activity and 10 indicating they are able to perform the activity at their preinjury level. The final score is an average of all scores provided. Change was calculated by subtracting the baseline PSFS from the post-treatment PSFS. Between Baseline and Immediately after treatment (13 weeks after baseline)
Other Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment (13 Weeks) The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For average NPRS, patients are asked to rate what their pain was over the last week. Change was calculated by subtracting the baseline average NPRS from the post-treatment average NPRS. Between Baseline and Immediately after treatment (13 weeks after baseline)
Other Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment (13 Weeks) The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For worst NPRS, patients are asked to rate what was their worst (highest) level of pain was over the last week. Change was calculated by subtracting the baseline worst NPRS from the post-treatment worst NPRS. Between Baseline and Immediately after treatment (13 weeks after baseline)
Other Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) ADL Subscale From Baseline to 6 Months After Treatment Completion. The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Activity Daily Living (ADL) subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSADL from the 6 month HOOSADL. Between Baseline and 6 months after treatment completion
Other Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Symptoms Subscale From Baseline to 6 Months After Treatment Completion. The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Symptoms subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSSymptom from the 6 month HOOSSymptom. Between Baseline and 6 months after treatment completion
Other Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Pain Subscale From Baseline to 6 Months After Treatment Completion. The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Pain subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSPain from the 6 month HOOSPain. Between Baseline and 6 months after treatment completion
Other Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Sport Subscale From Baseline to 6 Months After Treatment Completion. The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Sport subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSSPort from the 6 month HOOSSport. Between Baseline and 6 months after treatment completion
Other Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) QOL Subscale From Baseline to 6 Months After Treatment Completion. The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Quality of Life (QOL) subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSQOL from the 6 month HOOSQOL. Between Baseline and 6 months after treatment completion
Other Change in Function Using the Patient Specific Functional Scale From Baseline to 6 Months After Treatment Completion. The Patient Specific Functional Scale (PSFS), a patient-reported outcome measure of patient-specific activity limitations. Patients are asked to identify "3-5 activities you are unable to do or having difficulties performing due to the pain or symptoms in your hip". Patients then rated level of difficulty from 0-10, 0 indicating they are unable to perform the activity and 10 indicating they are able to perform the activity at their preinjury level. The final score is an average of all scores provided. Change was calculated by subtracting the baseline PSFS from the 6 month PSFS. Between Baseline and 6 months after treatment completion
Other Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to 6 Months After Treatment Completion. The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For average NPRS, patients are asked to rate what their pain was over the last week. Change was calculated by subtracting the baseline average NPRS from the 6 month average NPRS. Between Baseline and 6 months after treatment completion
Other Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to 6 Months After Treatment Completion. The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For worst NPRS, patients are asked to rate what was their worst (highest) level of pain was over the last week. Change was calculated by subtracting the baseline worst NPRS from the 6 month worst NPRS. Between Baseline and 6 months after treatment completion
Other Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) ADL Subscale From Baseline to 12 Months After Treatment Completion. The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Activity Daily Living (ADL) subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSADL from the 12 month HOOSADL. Between 12 months after treatment completion
Other Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Symptom Subscale From Baseline to 12 Months After Treatment Completion. The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Symptom subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSSymptom from the 12 month HOOSSymptom. Between Baseline and 12 months after treatment completion
Other Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Pain Subscale From Baseline to 12 Months After Treatment Completion. The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Pain subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSPain from the 12 month HOOSPain. Between Baseline and 12 months after treatment completion
Other Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Sport Subscale From Baseline to 12 Months After Treatment Completion. The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Sport subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSSport from the 12 month HOOSSport. Between Baseline and 12 months after treatment completion
Other Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) QOL Subscale From Baseline to 12 Months After Treatment Completion. The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Quality of Life (QOL) subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSQOL from the 12 month HOOSQOL. Between Baseline and 12 months after treatment completion
Other Change in Function Using the Patient Specific Functional Scale From Baseline to 12 Months After Treatment Completion. The Patient Specific Functional Scale (PSFS), a patient-reported outcome measure of patient-specific activity limitations. Patients are asked to identify "3-5 activities you are unable to do or having difficulties performing due to the pain or symptoms in your hip". Patients then rated level of difficulty from 0-10, 0 indicating they are unable to perform the activity and 10 indicating they are able to perform the activity at their preinjury level. The final score is an average of all scores provided. Change was calculated by subtracting the baseline PSFS from the 12 month PSFS. Between Baseline and 12 months after treatment completion
Other Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to 12 Months After Treatment Completion. The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For average NPRS, patients are asked to rate what their pain was over the last week. Change was calculated by subtracting the baseline average NPRS from the 12 month average NPRS. between Baseline and 12 months after treatment completion
Other Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to 12 Months After Treatment Completion. The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For worst NPRS, patients are asked to rate what was their worst (highest) level of pain was over the last week. Change was calculated by subtracting the baseline worst NPRS from the 12 month worst NPRS. Between Baseline and 12 months after treatment completion
Other Change in Glutueus Minimus Muscle Volume From Baseline to Post-treatment (13 Weeks) The outcome reported is the change (increase) in gluteus minimus muscle volume measured in centimeters cubed, using magnetic resonance imaging. Positive scores indicate an increase in volume. Change was calculated by subtracting the baseline muscle volume from the post-treatment muscle volume. Between Baseline and Immediately after treatment (13 weeks after baseline)
Other Change in Gluteus Minimus Muscle Fatty Infiltration From Baseline to Post-treatment (13 Weeks) The outcome reported is the change (decrease) in the proportion of fatty infiltration within the gluteus maximus muscle, measured by magnetic resonance imaging. A muscle fat index (MFI) was calculated to represent the proportion of fat within a muscle. To be able to analyze fat across the entire length of the muscle (from proximal to distal), muscle length was normalized so that 0% represented the most proximal slice and 100% represented the most distal slice. Mean MFI within every slice was then represented at every 1% of muscle length using spline interpolation. Between Baseline and Immediately after treatment (13 weeks after baseline)
Other Change in Gluteus Medius Muscle Volume From Baseline to Post-treatment (13 Weeks) The outcome reported is the change (increase) in gluteus medius muscle volume measured in centimeters cubed, using magnetic resonance imaging. Positive scores indicate an increase in volume. Change was calculated by subtracting the baseline muscle volume from the post-treatment muscle volume. Between Baseline and Immediately after treatment (13 weeks after baseline)
Other Change in Gluteus Maximus Muscle Volume From Baseline to Post-treatment (13 Weeks) The outcome reported is the change (increase) in gluteus maximus muscle volume measured in centimeters cubed, using magnetic resonance imaging. Positive scores indicate an increase in volume. Change was calculated by subtracting the baseline muscle volume from the post-treatment muscle volume. Between Baseline and Immediately after treatment (13 weeks after baseline)
Other Change in Gluteus Medius Muscle Fatty Infiltration From Baseline to Post-treatment (13 Weeks) The outcome reported is the change (decrease) in the proportion of fatty infiltration within the gluteus maximus muscle, measured by magnetic resonance imaging. A muscle fat index (MFI) was calculated to represent the proportion of fat within a muscle. To be able to analyze fat across the entire length of the muscle (from proximal to distal), muscle length was normalized so that 0% represented the most proximal slice and 100% represented the most distal slice. Mean MFI within every slice was then represented at every 1% of muscle length using spline interpolation. Between Baseline and Immediately after treatment (13 weeks after baseline)
Other Change in Gluteus Maximus Muscle Fatty Infiltration From Baseline to Post-treatment (13 Weeks) The outcome reported is the change (decrease) in the proportion of fatty infiltration within the gluteus maximus muscle, measured by magnetic resonance imaging. A muscle fat index (MFI) was calculated to represent the proportion of fat within a muscle. To be able to analyze fat across the entire length of the muscle (from proximal to distal), muscle length was normalized so that 0% represented the most proximal slice and 100% represented the most distal slice. Mean MFI within every slice was then represented at every 1% of muscle length using spline interpolation. Between Baseline and Immediately after treatment (13 weeks after baseline)
Primary Percentage of Participants Who Are Adherent to Treatment Attendance Percentage of study participants who attend 90% (9/10) of the supervised treatment sessions. Immediately after treatment (13 weeks after baseline)
Secondary Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Activities in Daily Living Subscale From Baseline to Post-treatment (13 Weeks) The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Activities in Daily Living subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOS Activities in Daily Living from the post-treatment HOOS Activities in Daily Living . Immediately after treatment (13 weeks after baseline)
Secondary Change in Hip Disability and Osteoarthritis Outcome Score (HOOS) Symptoms Subscale From Baseline to Post-treatment (13 Weeks) The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOSSymptoms subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSSymptoms from the post-treatment HOOSSymptoms. Immediately after treatment (13 weeks after baseline)

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