Femoroacetabular ImpingementNCT01814124
Conservative Management of Femoroacetabular Impingement
A study testing Manual therapy plus exercise and Advice and home exercise in people with Femoroacetabular Impingement, run by High Point University at 1 site in United States.
Trial summary
Femoroacetabular impingement (FAI) is recognized as a formal source of hip pain and disability typically affecting the young adult, active population and has been identified as a precursor to hip osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Manual therapy plus exercise and Advice and home exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to May 2015
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The participants will include new and existing patients with a diagnosis of femoroacetabular impingement and are being seen for an outpatient consultation for consideration of hip arthroscopy surgery.
- From direct correspondence with Dr. Stubbs, criteria for formal diagnosis of FAI includes a combination of clinical diagnosis supported with radiography.
- Clinical examination typically consists of reported hip pain, decreased flexion (<95o), decreased internal rotation (<10o), and
- a positive anterior impingement test result (report of deep, anterior groin pain following combination of flexion, internal rotation, and adduction).
- Use of an alpha angle is also used as a distinct characteristic with patient's having an alpha angle of > 50-55 degrees at increased risk for FAI.
Who cannot join
- previous hip surgery;
- any other surgical procedure of the lower limbs in the prior 6 months;
- pre-existing disease state of the hip such as rheumatoid arthritis;
- fracture;
- congenital/developmental hip dysplasia;
- initiation of opioid analgesia or cortico-steroid or analgesic injection intervention for hip pain within prior 30 days;
Show all 15Show fewer
- physical impairments unrelated to the hip preventing safe participation in exercise, manual therapy, walking or stationary cycling;
- advanced osteoporosis;
- body mass index > 38;
- significant cardio-pulmonary disease;
- cardiac pacemaker;
- stated inability to complete the proposed course of intervention and follow-up;
- insufficient English language skills to comprehend assessment tools;
- resident greater than 90 minutes from Wake Forest Baptist Medical Center.
- Individuals with contraindications to treatment with mobilization and manipulation
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Human Health and Sports Science Research
High Point, North Carolina, 27262
About this study
Official title: Therapeutic Effectiveness of Manual Therapy Plus Exercise for Femoroacetabular Impingement of the Hip: a Randomized Controlled Clinical Trial Pilot Study
Femoroacetabular impingement (FAI) is recognized as a formal source of hip pain and disability typically affecting the young adult, active population and has been identified as a precursor to hip osteoarthritis (OA). Common impairments include sharp, anterior groin pain in a position of hip flexion limiting patients' ability to tolerate prolonged sitting, squatting, stair climbing, etc. resulting in both work limitations and decreased social participation. Manual therapy and exercise is known to be effective in reducing pain and increasing physical function in the management of hip OA. To the extent that FAI is often a precursor to developing hip OA, logic would seem to dictate a manual therapy plus exercise approach to decrease pain and disability and potentially prevent or delay osteoarthritis related surgery. Currently, surgery is considered the first line of treatment with respect to FAI. However, there is a lack of evidence to support or refute the use of conservative treatment interventions in this patient population.
This study is designed to investigate the benefits of physical therapy interventions (manual therapy and exercise) over usual care for improving pain and physical function in patients with FAI of the hip. For this study, 52 participants will be recruited from the Department of Orthopaedic Surgery, Wake Forest Baptist Medical Center, for an outpatient consultation for consideration of hip arthroscopy surgery. Participants will include those patients who meet clinical and radiological criteria for formal diagnosis of FAI. Participants will be randomized into two treatment groups. Participants in one group will receive usual care plus manual therapy directed at the hip as well as a supervised exercise program and home exercise program twice weekly for six weeks. Participants in the usual care group will receive usual care as prescribed by the physician. Changes in pain, physical function and benefits of the intervention will be assessed over six weeks. Should this research study demonstrate treatment effectiveness of physical therapy intervention in patients diagnosed with FAI of the hip, manual therapy plus exercise may have the potential to delay or prevent surgery in this patient population. Further, to the extent to which FAI has been shown to lead to later development of hip OA, effective treatment interventions may help to delay or prevent secondary osteoarthritis related changes as well as total joint replacement surgery associated with hip OA. This study will provide preliminary data that can be used to prepare further grant applications designed to determine the safest, most effective treatments for patients with FAI.
- Conditions
- Femoroacetabular Impingement
- Being tested
- Manual therapy plus exercise, Advice and home exercise
- 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 therapy plus exerciseOther
Advice and home exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Advice and home exercise | Active comparator | All participants will be given a handout consisting of education about avoidance of certain activities as well as 3 stretches and 3 strengthening exercises to be performed as a home exercise program 2-3x/week Receives: Other: Advice and home exercise |
| Manual Therapy Plus Exercise | Experimental | Participants in this group will be given the same handout consisting of education about avoidance of certain activities as well as 3 stretches and 3 strengthening exercises to be performed as a home exercise program 2-3x/week.
Participants in this group will also receive 12 individualized physical therapy treatment sessions (2x/week for 6 weeks) consisting of both manual therapy and exercise directed at the hip and surrounding areas based upon findings from the initial examination. Participants will also be given additional exercises to be performed at home as directed by the treating physical therapist Receives: Other: Manual therapy plus exercise; Other: Advice and home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Outcome Score
Participants will fill out the Hip Outcome Score (HOS). The HOS is a 29-item instrument. Patient data from the HOS has been reported as reliable, valid, and responsive specific to this patient population and has been identified as the best available questionnaire for assessing younger patients undergoing hip arthroscopy. Test-retest reliability has been reported in the range of ICC = 0.92 - 0.98; internal consistency measures at cronbach's alpha = 0.96, 0.95; and responsiveness characteristics with effect sizes post-surgery ranging from 1.2-1.5.
Measured: Change from baseline functional status at 6 weeks
Numeric Pain Rating Scale
Lower extremity pain will be recorded using the Numeric Pain Rating Scale (NPRS). Participants will be asked to report their pain levels from no pain (0/10) to worse imaginable pain (10/10). This scale has been demonstrated to be a reliable, generalizable, internally consistent measure of clinical and experimental pain sensation intensity.
Measured: Change from baseline pain level at 6 weeks
Secondary outcomes (3)
Functional Squat
The functional squat test is considered to be a provocative test that also serves as a measure of function. A digital inclinometer will be placed on the tibia just distal to the tibial tuberosity. The participants will be asked to bend the knees and bring their buttocks toward their heels without bending forward or lifting their heels off the floor. The range of motion measurement will be taken at the greatest range of motion at which the participant was able to maintain good form or the first point of reported pain. The functional squat test has good reported reliability (ICC = 0.90 - 0.92) and responsiveness with standard error of measurement of 1.9.
Measured: Change from baseline functional status at 6 weeks
Global Rating of Change Scale
The Global Rating of Change Scale (GRCS) will be completed by each participant to rate their own perception of improved hip function. The GRCS questionnaire is an instrument that measures overall changes in the quality of life of the subject. The use of a GRCS is a common, feasible, and useful method for assessing outcome, and has been shown to be a valid measurement of change in patient status in patients with knee OA and other pain populations
Measured: 6 weeks
Lower Extremity Functional Scale
General lower extremity function will be quantified using the LEFS. The LEFS is a 20 item instrument with reported test-retest reliability of ICC = 0.98; internal consistency measures of cronbach's alpha = 0.96; and responsiveness characteristics of area under the curve of 0.77
Measured: Change from baseline general functional status at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- High Point University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814124
- Sponsor's protocol ID
- 201207-116
- Status last verified
- Feb 2016
- First submitted
- 14 Mar 2013
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wright AA, Hegedus EJ, Taylor JB, Dischiavi SL, Stubbs AJ. Non-operative management of femoroacetabular impingement: A prospective, randomized controlled clinical trial pilot study. J Sci Med Sport. 2016 Sep;19(9):716-21. doi: 10.1016/j.jsams.2015.11.008. Epub 2016 Jan 6.
PubMed 26795448
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effectiveness of Manual Therapy Plus Exercise for Femoroacetabular Impingement of the Hip: a Randomized Controlled Clinical Trial Pilot Study
- ClinicalTrials.gov ID
- NCT01814124
- Acronym / sponsor ID
- 201207-116
- Conditions
- Femoroacetabular Impingement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- High Point UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Mar 2013 (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.
Femoroacetabular impingement (FAI) is recognized as a formal source of hip pain and disability typically affecting the young adult, active population and has been identified as a precursor to hip osteoarthritis (OA). Common impairments include sharp, anterior groin pain in a position of hip flexion limiting patients' ability to tolerate prolonged sitting, squatting, stair climbing, etc. resulting in both work limitations and decreased social participation. Manual therapy and exercise is known to be effective in reducing pain and increasing physical function in the management of hip OA. To the extent that FAI is often a precursor to developing hip OA, logic would seem to dictate a manual therapy plus exercise approach to decrease pain and disability and potentially prevent or delay osteoarthritis related surgery. Currently, surgery is considered the first line of treatment with respect to FAI. However, there is a lack of evidence to support or refute the use of conservative treatment interventions in this patient population.
This study is designed to investigate the benefits of physical therapy interventions (manual therapy and exercise) over usual care for improving pain and physical function in patients with FAI of the hip. For this study, 52 participants will be recruited from the Department of Orthopaedic Surgery, Wake Forest Baptist Medical Center, for an outpatient consultation for consideration of hip arthroscopy surgery. Participants will include those patients who meet clinical and radiological criteria for formal diagnosis of FAI. Participants will be randomized into two treatment groups. Participants in one group will receive usual care plus manual therapy directed at the hip as well as a supervised exercise program and home exercise program twice weekly for six weeks. Participants in the usual care group will receive usual care as prescribed by the physician. Changes in pain, physical function and benefits of the intervention will be assessed over six weeks. Should this research study demonstrate treatment effectiveness of physical therapy intervention in patients diagnosed with FAI of the hip, manual therapy plus exercise may have the potential to delay or prevent surgery in this patient population. Further, to the extent to which FAI has been shown to lead to later development of hip OA, effective treatment interventions may help to delay or prevent secondary osteoarthritis related changes as well as total joint replacement surgery associated with hip OA. This study will provide preliminary data that can be used to prepare further grant applications designed to determine the safest, most effective treatments for patients with FAI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advice and home exercise | Active comparator | Other: Advice and home exerciseAll participants will be given a handout consisting of education about avoidance of certain activities as well as 3 stretches and 3 strengthening exercises to be performed as a home exercise program 2-3x/week |
| Manual Therapy Plus Exercise | Experimental | Other: Manual therapy plus exercise, Other: Advice and home exerciseParticipants in this group will be given the same handout consisting of education about avoidance of certain activities as well as 3 stretches and 3 strengthening exercises to be performed as a home exercise program 2-3x/week. Participants in this group will also receive 12 individualized physical therapy treatment sessions (2x/week for 6 weeks) consisting of both manual therapy and exercise directed at the hip and surrounding areas based upon findings from the initial examination. Participants will also be given additional exercises to be performed at home as directed by the treating physical therapist |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The participants will include new and existing patients with a diagnosis of femoroacetabular impingement and are being seen for an outpatient consultation for consideration of hip arthroscopy surgery.
- From direct correspondence with Dr. Stubbs, criteria for formal diagnosis of FAI includes a combination of clinical diagnosis supported with radiography.
- Clinical examination typically consists of reported hip pain, decreased flexion (<95o), decreased internal rotation (<10o), and
- a positive anterior impingement test result (report of deep, anterior groin pain following combination of flexion, internal rotation, and adduction).
- Use of an alpha angle is also used as a distinct characteristic with patient's having an alpha angle of > 50-55 degrees at increased risk for FAI.
Key exclusion criteria (15 listed)
- previous hip surgery;
- any other surgical procedure of the lower limbs in the prior 6 months;
- pre-existing disease state of the hip such as rheumatoid arthritis;
- fracture;
- congenital/developmental hip dysplasia;
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 therapy plus exercise | Other | Manual Therapy Plus Exercise |
| Advice and home exercise | Other | Advice and home exercise, Manual Therapy Plus Exercise |
Primary outcome
Hip Outcome Score
Time frame: Change from baseline functional status at 6 weeks
Participants will fill out the Hip Outcome Score (HOS). The HOS is a 29-item instrument. Patient data from the HOS has been reported as reliable, valid, and responsive specific to this patient population and has been identified as the best available questionnaire for assessing younger patients undergoing hip arthroscopy. Test-retest reliability has been reported in the range of ICC = 0.92 - 0.98; internal consistency measures at cronbach's alpha = 0.96, 0.95; and responsiveness characteristics with effect sizes post-surgery ranging from 1.2-1.5.
Numeric Pain Rating Scale
Time frame: Change from baseline pain level at 6 weeks
Lower extremity pain will be recorded using the Numeric Pain Rating Scale (NPRS). Participants will be asked to report their pain levels from no pain (0/10) to worse imaginable pain (10/10). This scale has been demonstrated to be a reliable, generalizable, internally consistent measure of clinical and experimental pain sensation intensity.
3 secondary outcomes
Functional Squat
Time frame: Change from baseline functional status at 6 weeks
Global Rating of Change Scale
Time frame: 6 weeks
Lower Extremity Functional Scale
Time frame: Change from baseline general functional status at 6 weeks
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 25 Feb 2016.
- Derived from this study: PubMed 26795448Wright AA, Hegedus EJ, Taylor JB, Dischiavi SL, Stubbs AJ. Non-operative management of femoroacetabular impingement: A prospective, randomized controlled clinical trial pilot study. J Sci Med Sport. 2016 Sep;19(9):716-21. doi: 10.1016/j.jsams.2015.11.008. Epub 2016 Jan 6.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy plus exercise and Advice and home exercise in people with Femoroacetabular Impingement, run by High Point University 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 5 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 25 Feb 2016. 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?
Hip Outcome Score (time frame: Change from baseline functional status at 6 weeks). The study lists 2 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 NCT01814124, which also lists 1 linked publication.
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 25 Feb 2016.