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

Femoroacetabular Impingement Clinical Trial

Official title:

Comparison of Movement Pattern Training and Manual Therapy for Prearthritic Hip Disorders: a Pilot Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03959319
• Other study ID #: 201901005
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysplasia Mild
• Femoracetabular Impingement
• Femoroacetabular Impingement
• Hip-related Groin Pain
• Prearthritic Hip Disorder

Intervention

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.
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Foundation for Physical Therapy, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. — View 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. Erratum In: Arch Phys Med Rehabil. 2013 Mar;94(3):600. Fitzpatrick, Martina [added]. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Function Using the Hip disability and Osteoarthritis Outcome Score Activities of Daily Living Subscale	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.	Immediately after treatment (13 weeks after baseline)
Primary	Change in Function Using the Hip disability and Osteoarthritis Outcome Score Symptom Subscale	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.	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)
Primary	Retention Rate	Percentage of those enrolled at baseline who completed testing after treatment	Immediately after treatment (13 weeks after baseline)
Secondary	Home Exercise Program (HEP) adherence	Participants were instructed to perform their HEP 5 times per week1 time per day. The variable for HEP adherence was calculated as the total number of days reported by the participant to have completed the prescribed exercises, summed over the entire treatment period, and divided by the total number of treatment days.	Immediately after treatment (13 weeks after baseline)
Secondary	Patient treatment receipt	The total number of exercises the physical therapist reviewed and the total number of those exercises they rated as independent were each summed across all treatment visits to derive the percent of exercises rated as independent across the entire treatment (S independent / S reviewed * 100).	Immediately after treatment (13 weeks after baseline)
Secondary	Active ingredients for treatment delivery	Treatment delivery assessed using chart reviews to determine if the active ingredients of the treatment was provided. The variable for treatment delivery is the proportion of active ingredients completed and documented by the treatment physical therapists for XX treatment visits	Immediately after treatment (13 weeks after baseline)
Secondary	Change in hip adduction angle	Change in hip adduction angle during functional tasks. Variable to assess movement pattern changes.	Immediately after treatment (13 weeks after baseline)
Secondary	Change in hip adduction angle	Change in hip adduction angle during functional tasks. Variable to assess movement pattern changes.	On year after treatment completion
Secondary	Change in pain pressure threshold	Pain pressure threshold is assessed with an algometer. This is a quantitative sensory testing to assess the patient's sensitivity to stimuli.	Immediately after treatment (13 weeks after baseline)
Secondary	Change in pain pressure threshold	Pain pressure threshold is assessed with an algometer. This is a quantitative sensory testing to assess the patient's sensitivity to stimuli.	One year after treatment completion
Secondary	Change in Function Using the Hip disability and Osteoarthritis Outcome Score Pain Subscale	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.	Immediately after treatment (13 weeks after baseline)
Secondary	Change in Function Using the Hip disability and Osteoarthritis Outcome Score Pain Subscale	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.	One year after treatment completion
Secondary	Change in Function Using the Hip disability and Osteoarthritis Outcome Score Sport and Recreation Subscale	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.	Immediately after treatment (13 weeks after baseline)
Secondary	Change in Function Using the Hip disability and Osteoarthritis Outcome Score Sport and Recreation Subscale	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.	One year after treatment completion
Secondary	Change in Function Using the Hip disability and Osteoarthritis Outcome Score Quality of Life Subscale	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.	Immediately after treatment (13 weeks after baseline)
Secondary	Change in Function Using the Hip disability and Osteoarthritis Outcome Score Quality of Life Subscale	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.	One year after treatment completion
Secondary	Change in Function Using the Hip disability and Osteoarthritis Outcome Score Activities of Daily Living Subscale	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.	One year after treatment completion
Secondary	Change in Function Using the Hip disability and Osteoarthritis Outcome Score Symptom Subscale	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.	One year after treatment completion
Secondary	Change in movement evoked pain	Movement evoked pain was assessed as a Numeric Pain Rating Scale (NPRS) after performance of a repetitive step down task and a repetitive deep squat task.	Immediately after treatment (13 weeks after baseline)
Secondary	Change in movement evoked pain	Movement evoked pain was assessed as a Numeric Pain Rating Scale (NPRS) after performance of a repetitive step down task and a repetitive deep squat task.	One year after treatment completion
Secondary	Change in Function Using the International Hip Outcome Tool (iHOT-33)	The iHOT is a hip-specific patient-reported outcome measure that represents the patient's report of symptoms, activity limitations, as well as emotional and social status. the score ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.	Immediately after treatment (13 weeks after baseline)
Secondary	Change in Function Using the International Hip Outcome Tool (iHOT-33)	The iHOT is a hip-specific patient-reported outcome measure that represents the patient's report of symptoms, activity limitations, as well as emotional and social status. the score ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.	One year after treatment completion
Secondary	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.	Immediately after treatment (13 weeks after baseline)
Secondary	Change in Function Using the Patient Specific Functional Scale From Baseline to Post-treatment	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.	One year after treatment completion
Secondary	Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment	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.	Immediately after treatment (13 weeks after baseline)
Secondary	Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment	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.	One year after treatment completion
Secondary	Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment	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.	Immediately after treatment (13 weeks after baseline)
Secondary	Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment	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.	One year after treatment completion