Clinical trial NCT01814124: Conservative Management of Femoroacetabular Impingement
Official title: Therapeutic Effectiveness of Manual Therapy Plus Exercise for Femoroacetabular Impingement of the Hip: a Randomized Controlled Clinical Trial Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoroacetabular Impingement
Lead sponsor: High Point University
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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

Primary outcomes:
measure: Hip Outcome Score
timeFrame: Change from baseline functional status at 6 weeks
measure: Numeric Pain Rating Scale
timeFrame: Change from baseline pain level at 6 weeks
Secondary outcomes:
measure: Functional Squat
timeFrame: Change from baseline functional status at 6 weeks
measure: Global Rating of Change Scale
timeFrame: 6 weeks
measure: Lower Extremity Functional Scale
timeFrame: Change from baseline general functional status at 6 weeks
Other outcomes:
Locations:
city: High Point
country: United States
facility: Institute for Human Health and Sports Science Research
state: North Carolina
Study officials:
References:
citation: 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.