Clinical trial NCT03959319: Comparison of Movement Pattern Training and Manual Therapy for Prearthritic Hip Disorders
Official title: Comparison of Movement Pattern Training and Manual Therapy for Prearthritic Hip Disorders: a Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip-related Groin Pain
Femoroacetabular Impingement
Dysplasia Mild
Prearthritic Hip Disorder
Keywords: clinical trial
rehabilitation
joint mobilization
movement training
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Foundation for Physical Therapy, Inc.
First posted: 2019-05-22
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief summary: 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.

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) 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:

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:

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

Impact: 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.


Eligibility 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
  * Ehler's Danlos Syndrome

Primary outcomes:
measure: Change in Function Using the Hip disability and Osteoarthritis Outcome Score Activities of Daily Living Subscale
timeFrame: Immediately after treatment (13 weeks after baseline)
measure: Change in Function Using the Hip disability and Osteoarthritis Outcome Score Symptom Subscale
timeFrame: Immediately after treatment (13 weeks after baseline)
measure: Percentage of Participants Who Are Adherent to Treatment Attendance
timeFrame: Immediately after treatment (13 weeks after baseline)
measure: Retention Rate
timeFrame: Immediately after treatment (13 weeks after baseline)
Secondary outcomes:
measure: Home Exercise Program (HEP) adherence
timeFrame: Immediately after treatment (13 weeks after baseline)
measure: Patient treatment receipt
timeFrame: Immediately after treatment (13 weeks after baseline)
measure: Active ingredients for treatment delivery
timeFrame: Immediately after treatment (13 weeks after baseline)
measure: Change in hip adduction angle
timeFrame: Immediately after treatment (13 weeks after baseline)
measure: Change in hip adduction angle
timeFrame: On year after treatment completion
measure: Change in pain pressure threshold
timeFrame: Immediately after treatment (13 weeks after baseline)
measure: Change in pain pressure threshold
timeFrame: One year after treatment completion
measure: Change in Function Using the Hip disability and Osteoarthritis Outcome Score Pain Subscale
timeFrame: Immediately after treatment (13 weeks after baseline)
measure: Change in Function Using the Hip disability and Osteoarthritis Outcome Score Pain Subscale
timeFrame: One year after treatment completion
measure: Change in Function Using the Hip disability and Osteoarthritis Outcome Score Sport and Recreation Subscale
timeFrame: Immediately after treatment (13 weeks after baseline)
measure: Change in Function Using the Hip disability and Osteoarthritis Outcome Score Sport and Recreation Subscale
timeFrame: One year after treatment completion
measure: Change in Function Using the Hip disability and Osteoarthritis Outcome Score Quality of Life Subscale
timeFrame: Immediately after treatment (13 weeks after baseline)
measure: Change in Function Using the Hip disability and Osteoarthritis Outcome Score Quality of Life Subscale
timeFrame: One year after treatment completion
measure: Change in Function Using the Hip disability and Osteoarthritis Outcome Score Activities of Daily Living Subscale
timeFrame: One year after treatment completion
measure: Change in Function Using the Hip disability and Osteoarthritis Outcome Score Symptom Subscale
timeFrame: One year after treatment completion
measure: Change in movement evoked pain
timeFrame: Immediately after treatment (13 weeks after baseline)
measure: Change in movement evoked pain
timeFrame: One year after treatment completion
measure: Change in Function Using the International Hip Outcome Tool (iHOT-33)
timeFrame: Immediately after treatment (13 weeks after baseline)
measure: Change in Function Using the International Hip Outcome Tool (iHOT-33)
timeFrame: One year after treatment completion
measure: Change in Function Using the Patient Specific Functional Scale From Baseline to Post-treatment (13 Weeks)
timeFrame: Immediately after treatment (13 weeks after baseline)
measure: Change in Function Using the Patient Specific Functional Scale From Baseline to Post-treatment
timeFrame: One year after treatment completion
measure: Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment
timeFrame: 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
timeFrame: One year after treatment completion
measure: Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment
timeFrame: 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
timeFrame: One year after treatment completion
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Program in Physical Therapy, Washington University
state: Missouri
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Moss P, Sluka K, Wright A. The initial effects of knee joint mobilization on osteoarthritic hyperalgesia. Man Ther. 2007 May;12(2):109-18. doi: 10.1016/j.math.2006.02.009. Epub 2006 Jun 13.
citation: 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.