Hip-related Groin PainNCT03959319
Comparison of Movement Pattern Training and Manual Therapy for Prearthritic Hip Disorders
A study testing Movement Pattern Training and Manual Therapy in people with Hip-related Groin Pain and Femoroacetabular Impingement, run by Washington University School of Medicine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Hip-related Groin Pain, Femoroacetabular Impingement, Dysplasia Mild
- What is being tested?
- Movement Pattern Training and Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Program in Physical Therapy, Washington University
St Louis, Missouri, 63108
About this study
Official title: Comparison of Movement Pattern Training and Manual Therapy for Prearthritic Hip Disorders: a Pilot Randomized Clinical Trial
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.
Read more
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.
- Conditions
- Hip-related Groin Pain, Femoroacetabular Impingement, Dysplasia Mild, Prearthritic Hip Disorder
- Being tested
- Movement Pattern Training, Manual Therapy
- Keywords
- clinical trial, rehabilitation, joint mobilization, movement training
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement Pattern TrainingOther
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 TherapyOther
Also called Joint Mobilization
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.
| Study group | Role | What they receive |
|---|---|---|
| Movement Pattern Training | Experimental | 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. Receives: Other: Movement Pattern Training |
| Manual Therapy (Joint Mobilization) | Active comparator | 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. Receives: Other: Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after treatment (13 weeks after baseline)
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.
Measured: Immediately after treatment (13 weeks after baseline)
Percentage of Participants Who Are Adherent to Treatment Attendance
Percentage of study participants who attend 90% (9/10) of the supervised treatment sessions.
Measured: Immediately after treatment (13 weeks after baseline)
Retention Rate
Percentage of those enrolled at baseline who completed testing after treatment
Measured: Immediately after treatment (13 weeks after baseline)
Secondary outcomes (25)
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.
Measured: Immediately after treatment (13 weeks after baseline)
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 (Σ independent / Σ reviewed * 100).
Measured: Immediately after treatment (13 weeks after baseline)
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
Measured: Immediately after treatment (13 weeks after baseline)
Change in hip adduction angle
Change in hip adduction angle during functional tasks. Variable to assess movement pattern changes.
Measured: Immediately after treatment (13 weeks after baseline)
Change in hip adduction angle
Change in hip adduction angle during functional tasks. Variable to assess movement pattern changes.
Measured: On year after treatment completion
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.
Measured: Immediately after treatment (13 weeks after baseline)
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.
Measured: One year after treatment completion
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.
Measured: Immediately after treatment (13 weeks after baseline)
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.
Measured: One year after treatment completion
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.
Measured: Immediately after treatment (13 weeks after baseline)
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.
Measured: One year after treatment completion
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.
Measured: Immediately after treatment (13 weeks after baseline)
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.
Measured: One year after treatment completion
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.
Measured: One year after treatment completion
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.
Measured: One year after treatment completion
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.
Measured: Immediately after treatment (13 weeks after baseline)
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.
Measured: One year after treatment completion
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.
Measured: Immediately after treatment (13 weeks after baseline)
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.
Measured: One year after treatment completion
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.
Measured: Immediately after treatment (13 weeks after baseline)
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.
Measured: One year after treatment completion
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.
Measured: Immediately after treatment (13 weeks after baseline)
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.
Measured: One year after treatment completion
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.
Measured: Immediately after treatment (13 weeks after baseline)
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.
Measured: One year after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start1 Jul 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hip-related Groin PainStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Physical Therapy, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959319
- Sponsor's protocol ID
- 201901005
- Status last verified
- Jan 2023
- First submitted
- 20 May 2019
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23313532Borrelli 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.
PubMed 21656954Chimenti 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.
PubMed 29669091Harris-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.
PubMed 27117727Harris-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.
PubMed 20411216Harris-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.
PubMed 25299750Harris-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.
PubMed 24955621Harris-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.
PubMed 29548270Hwang 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.
PubMed 29016389Moss 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.
PubMed 16777467French 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.
PubMed 23084955DeMargel RD, Steger-May K, Haroutounian S, Zorn P, Cheng A, Clohisy JC, Harris-Hayes M. Personal factors and baseline function in patients undergoing non-operative management for chronic hip-related groin pain: a cross-sectional study. BMJ Open Sport Exerc Med. 2023 Nov 3;9(4):e001685. doi: 10.1136/bmjsem-2023-001685. eCollection 2023.
PubMed 37937305
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Movement Pattern Training and Manual Therapy for Prearthritic Hip Disorders: a Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03959319
- Acronym / sponsor ID
- 201901005
- Conditions
- Hip-related Groin Pain, Femoroacetabular Impingement, Dysplasia Mild, Prearthritic Hip Disorder
- Keywords
- clinical trial, rehabilitation, joint mobilization, movement training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Foundation for Physical Therapy, Inc.
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Movement Pattern Training | Experimental | Other: Movement Pattern TrainingFocus 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. |
| Manual Therapy (Joint Mobilization) | Active comparator | Other: Manual TherapyFocus 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-40 years
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Movement Pattern TrainingTreatment 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 | Movement Pattern Training |
| Manual TherapyAlso: Joint MobilizationTreatment 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 | Manual Therapy (Joint Mobilization) |
Primary outcome
Change in Function Using the Hip disability and Osteoarthritis Outcome Score Activities of Daily Living Subscale
Time frame: Immediately after treatment (13 weeks after baseline)
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.
Change in Function Using the Hip disability and Osteoarthritis Outcome Score Symptom Subscale
Time frame: Immediately after treatment (13 weeks after baseline)
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.
Percentage of Participants Who Are Adherent to Treatment Attendance
Time frame: Immediately after treatment (13 weeks after baseline)
Percentage of study participants who attend 90% (9/10) of the supervised treatment sessions.
Retention Rate
Time frame: Immediately after treatment (13 weeks after baseline)
Percentage of those enrolled at baseline who completed testing after treatment
25 secondary outcomes
Home Exercise Program (HEP) adherence
Time frame: Immediately after treatment (13 weeks after baseline)
Patient treatment receipt
Time frame: Immediately after treatment (13 weeks after baseline)
Active ingredients for treatment delivery
Time frame: Immediately after treatment (13 weeks after baseline)
Change in hip adduction angle
Time frame: Immediately after treatment (13 weeks after baseline)
Change in hip adduction angle
Time frame: On year after treatment completion
Change in pain pressure threshold
Time frame: Immediately after treatment (13 weeks after baseline)
Change in pain pressure threshold
Time frame: One year after treatment completion
Change in Function Using the Hip disability and Osteoarthritis Outcome Score Pain Subscale
Time frame: Immediately after treatment (13 weeks after baseline)
Change in Function Using the Hip disability and Osteoarthritis Outcome Score Pain Subscale
Time frame: One year after treatment completion
Change in Function Using the Hip disability and Osteoarthritis Outcome Score Sport and Recreation Subscale
Time frame: Immediately after treatment (13 weeks after baseline)
Change in Function Using the Hip disability and Osteoarthritis Outcome Score Sport and Recreation Subscale
Time frame: One year after treatment completion
Change in Function Using the Hip disability and Osteoarthritis Outcome Score Quality of Life Subscale
Time frame: Immediately after treatment (13 weeks after baseline)
Change in Function Using the Hip disability and Osteoarthritis Outcome Score Quality of Life Subscale
Time frame: One year after treatment completion
Change in Function Using the Hip disability and Osteoarthritis Outcome Score Activities of Daily Living Subscale
Time frame: One year after treatment completion
Change in Function Using the Hip disability and Osteoarthritis Outcome Score Symptom Subscale
Time frame: One year after treatment completion
Change in movement evoked pain
Time frame: Immediately after treatment (13 weeks after baseline)
Change in movement evoked pain
Time frame: One year after treatment completion
Change in Function Using the International Hip Outcome Tool (iHOT-33)
Time frame: Immediately after treatment (13 weeks after baseline)
Change in Function Using the International Hip Outcome Tool (iHOT-33)
Time frame: One year after treatment completion
Change in Function Using the Patient Specific Functional Scale From Baseline to Post-treatment (13 Weeks)
Time frame: Immediately after treatment (13 weeks after baseline)
Change in Function Using the Patient Specific Functional Scale From Baseline to Post-treatment
Time frame: One year after treatment completion
Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment
Time frame: Immediately after treatment (13 weeks after baseline)
Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment
Time frame: One year after treatment completion
Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment
Time frame: Immediately after treatment (13 weeks after baseline)
Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment
Time frame: One year after treatment completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Background: PubMed 23313532Abbott 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.
- Background: PubMed 21656954Borrelli 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.
- Background: PubMed 29669091Chimenti 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.
- Background: PubMed 27117727Harris-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.
- Background: PubMed 20411216Harris-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.
- Background: PubMed 25299750Harris-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.
- Background: PubMed 24955621Harris-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.
- Background: PubMed 29548270Harris-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.
- Background: PubMed 29016389Hwang 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.
- Background: PubMed 16777467Moss 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.
- Background: PubMed 23084955French 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.
- Derived from this study: PubMed 37937305DeMargel RD, Steger-May K, Haroutounian S, Zorn P, Cheng A, Clohisy JC, Harris-Hayes M. Personal factors and baseline function in patients undergoing non-operative management for chronic hip-related groin pain: a cross-sectional study. BMJ Open Sport Exerc Med. 2023 Nov 3;9(4):e001685. doi: 10.1136/bmjsem-2023-001685. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Hip-related Groin Pain
Recruiting
Education and Exercise for Patients With Longstanding Hip and Groin Pain
Hip Pain Chronic, Femoro Acetabular Impingement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movement Pattern Training and Manual Therapy in people with Hip-related Groin Pain and Femoroacetabular Impingement, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Function Using the Hip disability and Osteoarthritis Outcome Score Activities of Daily Living Subscale (time frame: Immediately after treatment (13 weeks after baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03959319, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.