Chronic Hip Joint PainNCT02913222
Movement Pattern Training in People With Intra-articular, Prearthritic Hip Disorders
A study testing Rehabilitation in people with Chronic Hip Joint Pain and Prearthritic Hip Disease, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
Intra-articular, prearthritic hip disorders (PAHD) result in substantial dysfunction in young adults and are proposed precursors to hip osteoarthritis (OA). Effective treatment of PAHD is needed to improve function in the young adult and prevent or delay the onset of hip OA, however evidence related to treatment of… Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Chronic Hip Joint Pain, Prearthritic Hip Disease
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Feb 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
Program in Physical Therapy, Washington University
St Louis, Missouri, 63108
About this study
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.
Read the 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.
- Conditions
- Chronic Hip Joint Pain, Prearthritic Hip Disease
- Being tested
- Rehabilitation
- Keywords
- femoroacetabular impingement, labral tear, rehabilitation
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Also called Physical Therapy, Therapeutic exercise
Comparison of two rehabilitation approaches
| Study group | Role | What they receive |
|---|---|---|
| Movement Pattern Training (MPT) | Experimental | Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. Movement Pattern Training (MPT) will focus on task-specific training to improve lower extremity movement patterns during basic 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. Exercises will include repeated practice of tasks using optimized movement patterns. Verbal cues and visual aids will be used to assist the participant. Difficulty of the task-specific activities will be progressed by varying repetitions performed, increasing load or changing the support surface. Receives: Other: Rehabilitation |
| Standard Rehabilitation | Active comparator | Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. For the Standard Rehabilitation, focus will be on progressive lower extremity and trunk strengthening and lower extremity flexibility. Patient education will include instruction to modify intensity, frequency or duration of patient-specific tasks. Using current clinical practice guidelines and previous reports, strengthening and flexibility exercises will be prescribed and progressed by varying the repetitions performed or increasing the load. Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Secondary outcomes (2)
Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Activities in Daily Living Subscale From Baseline to Post-treatment (13 Weeks)
The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Activities in Daily Living subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOS Activities in Daily Living from the post-treatment HOOS Activities in Daily Living .
Measured: Immediately after treatment (13 weeks after baseline)
Change in Hip Disability and Osteoarthritis Outcome Score (HOOS) Symptoms Subscale From Baseline to Post-treatment (13 Weeks)
The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOSSymptoms subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSSymptoms from the post-treatment HOOSSymptoms.
Measured: Immediately after treatment (13 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start4 Feb 2017
- Primary completion12 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Hip Joint 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Marcie Harris-Hayes, DPT, MSCI, Principal investigator, Washington University School of MedicineKelley Fitzgerald, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913222
- Sponsor's protocol ID
- R21HD086644-01A1-201609106
- Other IDs
- R21HD086644-01A1
- Status last verified
- Mar 2023
- First submitted
- 15 Sep 2016
- Last updated
- 27 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 33291065Koch 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.
PubMed 34370330Harris-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.
PubMed 33458839Harris-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.
PubMed 32518674
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement Pattern Training in People With Intra-articular, Prearthritic Hip Disorders
- ClinicalTrials.gov ID
- NCT02913222
- Acronym / sponsor ID
- R21HD086644-01A1-201609106
- Conditions
- Chronic Hip Joint Pain, Prearthritic Hip Disease
- Keywords
- femoroacetabular impingement, labral tear, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 4 Feb 2017 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Posted 12 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Movement Pattern Training (MPT) | Experimental | Other: RehabilitationTreatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. Movement Pattern Training (MPT) will focus on task-specific training to improve lower extremity movement patterns during basic 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. Exercises will include repeated practice of tasks using optimized movement patterns. Verbal cues and visual aids will be used to assist the participant. Difficulty of the task-specific activities will be progressed by varying repetitions performed, increasing load or changing the support surface. |
| Standard Rehabilitation | Active comparator | Other: RehabilitationTreatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. For the Standard Rehabilitation, focus will be on progressive lower extremity and trunk strengthening and lower extremity flexibility. Patient education will include instruction to modify intensity, frequency or duration of patient-specific tasks. Using current clinical practice guidelines and previous reports, strengthening and flexibility exercises will be prescribed and progressed by varying the repetitions performed or increasing the load. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| RehabilitationAlso: Physical Therapy, Therapeutic exerciseComparison of two rehabilitation approaches | Other | Movement Pattern Training (MPT), Standard Rehabilitation |
Primary 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.
2 secondary outcomes
Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Activities in Daily Living Subscale From Baseline to Post-treatment (13 Weeks)
Time frame: Immediately after treatment (13 weeks after baseline)
Change in Hip Disability and Osteoarthritis Outcome Score (HOOS) Symptoms Subscale From Baseline to Post-treatment (13 Weeks)
Time frame: Immediately after treatment (13 weeks after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundHarris-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.
- Background: PubMed 33291065Foster 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.
- Results publication: PubMed 34370330Koch 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.
- Results publication: PubMed 33458839Harris-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.
- Results publication: PubMed 32518674Harris-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.
- Rehabilitation Research for Orthopaedic Conditions (RROC)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Marcie Harris-Hayes, DPT, MSCI principal investigator
Washington University School of Medicine
Kelley Fitzgerald, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Chronic Hip Joint Pain and Prearthritic Hip Disease, run by Washington University School of Medicine at 2 sites 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 4 inclusion and 8 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 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 12 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Are Adherent to Treatment Attendance (time frame: Immediately after treatment (13 weeks after baseline)). 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 NCT02913222, which also lists 5 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 27 Mar 2023.