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Clinical Trials/NCT01814124
NCT01814124
Completed
Not Applicable

Therapeutic Effectiveness of Manual Therapy Plus Exercise for Femoroacetabular Impingement of the Hip: a Randomized Controlled Clinical Trial Pilot Study

High Point University1 site in 1 country18 target enrollmentMarch 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Femoroacetabular Impingement
Sponsor
High Point University
Enrollment
18
Locations
1
Primary Endpoint
Hip Outcome Score
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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;

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Global Rating of Change Scale(6 weeks)
  • Lower Extremity Functional Scale(Change from baseline general functional status at 6 weeks)
  • Functional Squat(Change from baseline functional status at 6 weeks)

Study Sites (1)

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