Clinical trial NCT02913222: Movement Pattern Training in People With Intra-articular, Prearthritic Hip Disorders
Official title: Movement Pattern Training in People With Intra-articular, Prearthritic Hip Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Hip Joint Pain
Prearthritic Hip Disease
Keywords: femoroacetabular impingement
labral tear
rehabilitation
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-09-23
Enrollment: 46
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Are Adherent to Treatment Attendance
timeFrame: Immediately after treatment (13 weeks after baseline)
Secondary outcomes:
measure: Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Activities in Daily Living Subscale From Baseline to Post-treatment (13 Weeks)
timeFrame: Immediately after treatment (13 weeks after baseline)
measure: Change in Hip Disability and Osteoarthritis Outcome Score (HOOS) Symptoms Subscale From Baseline to Post-treatment (13 Weeks)
timeFrame: Immediately after treatment (13 weeks after baseline)
Other outcomes:
measure: Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Pain Subscale From Baseline to Post-treatment (13 Weeks)
timeFrame: Between Baseline and Immediately after treatment (13 weeks after baseline)
measure: Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Sport Subscale From Baseline to Post-treatment (13 Weeks)
timeFrame: Between Baseline and Immediately after treatment (13 weeks after baseline)
measure: Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Quality of Life (QOL) Subscale From Baseline to Post-treatment (13 Weeks)
timeFrame: Between Baseline and Immediately after treatment (13 weeks after baseline)
measure: Change in Function Using the Patient Specific Functional Scale From Baseline to Post-treatment (13 Weeks)
timeFrame: Between Baseline and Immediately after treatment (13 weeks after baseline)
measure: Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment (13 Weeks)
timeFrame: Between Baseline and Immediately after treatment (13 weeks after baseline)
measure: Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment (13 Weeks)
timeFrame: Between Baseline and Immediately after treatment (13 weeks after baseline)
measure: Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) ADL Subscale From Baseline to 6 Months After Treatment Completion.
timeFrame: Between Baseline and 6 months after treatment completion
measure: Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Symptoms Subscale From Baseline to 6 Months After Treatment Completion.
timeFrame: Between Baseline and 6 months after treatment completion
measure: Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Pain Subscale From Baseline to 6 Months After Treatment Completion.
timeFrame: Between Baseline and 6 months after treatment completion
measure: Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Sport Subscale From Baseline to 6 Months After Treatment Completion.
timeFrame: Between Baseline and 6 months after treatment completion
measure: Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) QOL Subscale From Baseline to 6 Months After Treatment Completion.
timeFrame: Between Baseline and 6 months after treatment completion
measure: Change in Function Using the Patient Specific Functional Scale From Baseline to 6 Months After Treatment Completion.
timeFrame: Between Baseline and 6 months after treatment completion
measure: Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to 6 Months After Treatment Completion.
timeFrame: Between Baseline and 6 months after treatment completion
measure: Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to 6 Months After Treatment Completion.
timeFrame: Between Baseline and 6 months after treatment completion
measure: Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) ADL Subscale From Baseline to 12 Months After Treatment Completion.
timeFrame: Between 12 months after treatment completion
measure: Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Symptom Subscale From Baseline to 12 Months After Treatment Completion.
timeFrame: Between Baseline and 12 months after treatment completion
measure: Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Pain Subscale From Baseline to 12 Months After Treatment Completion.
timeFrame: Between Baseline and 12 months after treatment completion
measure: Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Sport Subscale From Baseline to 12 Months After Treatment Completion.
timeFrame: Between Baseline and 12 months after treatment completion
measure: Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) QOL Subscale From Baseline to 12 Months After Treatment Completion.
timeFrame: Between Baseline and 12 months after treatment completion
measure: Change in Function Using the Patient Specific Functional Scale From Baseline to 12 Months After Treatment Completion.
timeFrame: Between Baseline and 12 months after treatment completion
measure: Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to 12 Months After Treatment Completion.
timeFrame: between Baseline and 12 months after treatment completion
measure: Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to 12 Months After Treatment Completion.
timeFrame: Between Baseline and 12 months after treatment completion
measure: Change in Glutueus Minimus Muscle Volume From Baseline to Post-treatment (13 Weeks)
timeFrame: Between Baseline and Immediately after treatment (13 weeks after baseline)
measure: Change in Gluteus Minimus Muscle Fatty Infiltration From Baseline to Post-treatment (13 Weeks)
timeFrame: Between Baseline and Immediately after treatment (13 weeks after baseline)
measure: Change in Gluteus Medius Muscle Volume From Baseline to Post-treatment (13 Weeks)
timeFrame: Between Baseline and Immediately after treatment (13 weeks after baseline)
measure: Change in Gluteus Maximus Muscle Volume From Baseline to Post-treatment (13 Weeks)
timeFrame: Between Baseline and Immediately after treatment (13 weeks after baseline)
measure: Change in Gluteus Medius Muscle Fatty Infiltration From Baseline to Post-treatment (13 Weeks)
timeFrame: Between Baseline and Immediately after treatment (13 weeks after baseline)
measure: Change in Gluteus Maximus Muscle Fatty Infiltration From Baseline to Post-treatment (13 Weeks)
timeFrame: Between Baseline and Immediately after treatment (13 weeks after baseline)
Locations:
city: Saint Louis
country: United States
facility: Program in Physical Therapy, Washington University
state: Missouri
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Washington University School of Medicine
name: Marcie Harris-Hayes, DPT, MSCI
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Kelley Fitzgerald, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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. J Orthop Res. 2022 Jun;40(6):1375-1386. doi: 10.1002/jor.25158. Epub 2021 Aug 18.
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 Orthop Res. 2021 Nov;39(11):2409-2418. doi: 10.1002/jor.24985. Epub 2021 Mar 2.
citation: 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 clinical trial. BMJ Open Sport Exerc Med. 2020 Mar 23;6(1):e000707. doi: 10.1136/bmjsem-2019-000707. eCollection 2020.