Femoroacetabular ImpingementNCT02706756
Conservative Intervention of Femoroacetabular Impingement Syndrome
A study testing Manual therapy, Exercise and Education and advice in people with Femoroacetabular Impingement, run by Duke University.
Trial summary
1. Purpose: 1) compare three conservative treatment approaches for subjects with femoroacetabular impingement syndrome (FAI), and 2) analyze functional outcome comparatively across groups. 2. Interventions will be provided based on randomized assignment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Manual therapy, Exercise and Education and advice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals age 18 to 60 years,
- diagnosed with FAI by an orthopedic surgeon and exhibiting
- hip/groin symptoms for at least 3 months (symptomatic); and
- signs, symptoms and imaging findings conducive to FAI will be recruited from a surgical practice of an orthopedic surgeon in Durham, North Carolina.
Who cannot join
- subjects that have radiographic evidence of hip osteoarthritis that is more than mild in severity defined as Tonnis >grade 1 or Kellgren-Lawrence >2;
- have other concurrent injury/conditions that will affect their ability to participate in the rehabilitation program and/or assessment procedures;
- exhibit hip dysplasia (center edge angle <20 degrees on AP radiograph
- are unable to attend a study physiotherapist or participate in the rehabilitation program if randomized to the PT group;
- are unable to understand English.
About this study
Official title: Conservative Intervention of Femoroacetabular Impingement Syndrome: A Randomized Controlled Trial
- Purpose: 1) compare three conservative treatment approaches for subjects with femoroacetabular impingement syndrome (FAI), and 2) analyze functional outcome comparatively across groups.
- Interventions will be provided based on randomized assignment. Group 1 will receive treatment based on identified impairments and treated twice weekly to address said impairments with hip manual therapy and exercise, as well as a prescriptive exercise for strengthening and mobility of the hip. Group 2 will receive only the prescriptive exercise program. Group 3 will be a control group (supervised neglect)
- Primary outcomes data analysis will involve a mixed design (repeated measures) ANOVA for assessment of the primary outcome measure of the HAGOS. Secondary analyses will include chi square analyses (PASS, surgery at 6 months, adverse events), ANCOVA (PPMs, and expectations measures), or other appropriate comparative measures. None of the proposed treatment is considered outside of 'standard of practice'.
- Conditions
- Femoroacetabular Impingement
- Being tested
- Manual therapy, Exercise, Education and advice, Supervised neglect
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
Hip joint and spine manual therapy techniques applied toward the impairments of the subject.
ExerciseOther
Prescriptive exercise program of self-mobilization and/or strengthening program to address impairments of the subject.
Education and adviceOther
All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care).
Supervised neglectOther
Monitoring of group without formal intervention.
| Study group | Role | What they receive |
|---|---|---|
| Education, exercise and manual therapy | Experimental | One group will receive education and advice, manual therapy that is applied toward the impairments of the subject, a prescription of progressive rehabilitation exercises designed to strengthen weakened muscle groups and stretch joint movements that demonstrate range of motion limitations. Treatment is based on clinical presentation and identification of impairments by the treating clinician. Subjects will be seen twice weekly for 4 to 6 weeks, depending on the progression.
All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care). All interventions will be provided by licensed physical therapists that are named as investigators in this study. Receives: Other: Manual therapy; Other: Education and advice |
| Education and exercise | Active comparator | Group will receive a prescriptive intervention designed to strengthen the hip and surrounding regions as well as improve flexibility of the lower extremity. This group will not receive additional physiotherapy management but will be schedule bi-weekly to review the home exercises and to receive appropriate educational support.
All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care). All interventions will be provided by licensed physical therapists that are named as investigators in this study. Receives: Other: Exercise; Other: Education and advice |
| Supervised neglect | Placebo comparator | Group will receive supervised neglect. We will monitor this group for changes or emergent situations but no formal care will be provided.
All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care). All interventions will be provided by licensed physical therapists that are named as investigators in this study. Receives: Other: Education and advice; Other: Supervised neglect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Did subject elect to undergo surgery?
Determination of whether the subject had surgery for femoroacetabular impingement or not
Measured: up to 6 months after intervention
Secondary outcomes (9)
Change in Stanford Expectations of Treatment Scale (SETS)
subject expectation of treatment
Measured: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Patient Acceptable Symptom State (PASS)
subject acceptance of what their current symptom state is
Measured: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in numeric pain rating scale
Measured: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Hip and Groin Outcome Score
Measured: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Single leg stance (SLS)
measure of single leg balance and stability
Measured: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Lower Quarter Y Balance Test (YBT-LQ)
measure of single leg balance, strength and coordination
Measured: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Single Leg Anteroposterior Hop
Measure of single leg balance, strength, power and coordination
Measured: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Standing Hip Internal Rotation Range-of-Motion
Measure of single leg weight-bearing range of motion
Measured: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Complications/Adverse Events of assigned treatment
Measured: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: Similar studies already published by other researchers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706756
- Sponsor's protocol ID
- Pro00069234
- Status last verified
- Feb 2016
- First submitted
- 8 Mar 2016
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Intervention of Femoroacetabular Impingement Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02706756
- Acronym / sponsor ID
- Pro00069234
- Conditions
- Femoroacetabular Impingement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Similar studies already published by other researchers
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 11 Mar 2016 (estimated)
- 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.
- Purpose: 1) compare three conservative treatment approaches for subjects with femoroacetabular impingement syndrome (FAI), and 2) analyze functional outcome comparatively across groups.
- Interventions will be provided based on randomized assignment. Group 1 will receive treatment based on identified impairments and treated twice weekly to address said impairments with hip manual therapy and exercise, as well as a prescriptive exercise for strengthening and mobility of the hip. Group 2 will receive only the prescriptive exercise program. Group 3 will be a control group (supervised neglect)
- Primary outcomes data analysis will involve a mixed design (repeated measures) ANOVA for assessment of the primary outcome measure of the HAGOS. Secondary analyses will include chi square analyses (PASS, surgery at 6 months, adverse events), ANCOVA (PPMs, and expectations measures), or other appropriate comparative measures. None of the proposed treatment is considered outside of 'standard of practice'.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education, exercise and manual therapy | Experimental | Other: Manual therapy, Other: Education and adviceOne group will receive education and advice, manual therapy that is applied toward the impairments of the subject, a prescription of progressive rehabilitation exercises designed to strengthen weakened muscle groups and stretch joint movements that demonstrate range of motion limitations. Treatment is based on clinical presentation and identification of impairments by the treating clinician. Subjects will be seen twice weekly for 4 to 6 weeks, depending on the progression. All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care). All interventions will be provided by licensed physical therapists that are named as investigators in this study. |
| Education and exercise | Active comparator | Other: Exercise, Other: Education and adviceGroup will receive a prescriptive intervention designed to strengthen the hip and surrounding regions as well as improve flexibility of the lower extremity. This group will not receive additional physiotherapy management but will be schedule bi-weekly to review the home exercises and to receive appropriate educational support. All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care). All interventions will be provided by licensed physical therapists that are named as investigators in this study. |
| Supervised neglect | Placebo comparator | Other: Education and advice, Other: Supervised neglectGroup will receive supervised neglect. We will monitor this group for changes or emergent situations but no formal care will be provided. All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care). All interventions will be provided by licensed physical therapists that are named as investigators in this study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals age 18 to 60 years,
- diagnosed with FAI by an orthopedic surgeon and exhibiting
- hip/groin symptoms for at least 3 months (symptomatic); and
- signs, symptoms and imaging findings conducive to FAI will be recruited from a surgical practice of an orthopedic surgeon in Durham, North Carolina.
Key exclusion criteria (5 listed)
- subjects that have radiographic evidence of hip osteoarthritis that is more than mild in severity defined as Tonnis >grade 1 or Kellgren-Lawrence >2;
- have other concurrent injury/conditions that will affect their ability to participate in the rehabilitation program and/or assessment procedures;
- exhibit hip dysplasia (center edge angle <20 degrees on AP radiograph
- are unable to attend a study physiotherapist or participate in the rehabilitation program if randomized to the PT group;
- are unable to understand English.
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 |
|---|---|---|
| Manual therapyHip joint and spine manual therapy techniques applied toward the impairments of the subject. | Other | Education, exercise and manual therapy |
| ExercisePrescriptive exercise program of self-mobilization and/or strengthening program to address impairments of the subject. | Other | Education and exercise |
| Education and adviceAll three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care). | Other | Education and exercise, Education, exercise and manual therapy, Supervised neglect |
| Supervised neglectMonitoring of group without formal intervention. | Other | Supervised neglect |
Primary outcome
Did subject elect to undergo surgery?
Time frame: up to 6 months after intervention
Determination of whether the subject had surgery for femoroacetabular impingement or not
9 secondary outcomes
Change in Stanford Expectations of Treatment Scale (SETS)
Time frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Patient Acceptable Symptom State (PASS)
Time frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in numeric pain rating scale
Time frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Hip and Groin Outcome Score
Time frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Single leg stance (SLS)
Time frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Lower Quarter Y Balance Test (YBT-LQ)
Time frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Single Leg Anteroposterior Hop
Time frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Standing Hip Internal Rotation Range-of-Motion
Time frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Change in Complications/Adverse Events of assigned treatment
Time frame: initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Femoroacetabular Impingement
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
Not yet recruiting
The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
Femoroacetabular Impingement Syndrome, Femoro-acetabular Impingement
Active, not recruiting
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
Femoroacetabular Impingement Syndrome
Recruiting
Comparison of Surgery With Prehabilitation, Direct Surgery and Rehabilitation for Patients With Femoroacetabular Impingement
Femoroacetabular Impingement Syndrome
Not yet recruitingObservational study
Mapping Joint Damage Patterns in Femoroacetabular Impingement
Femoro-acetabular Impingement (FAI)
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.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy, Exercise and Education and advice in people with Femoroacetabular Impingement, run by Duke University.
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 5 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: withdrawn, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Did subject elect to undergo surgery? (time frame: up to 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2017.