Conservative Management of Femoroacetabular Impingement

Femoroacetabular Impingement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01814124
• Other study ID #: 201207-116
• Status: Completed
• Phase: N/A
• First received: March 14, 2013
• Last updated: February 24, 2016
• Start date: March 2013
• Est. completion date: May 2015

Study information

• Verified date: February 2016
• Source: High Point University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board, High Point University
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement

Intervention

Other:
• Manual therapy plus exercise

• Advice and home exercise

Locations

Country	Name	City	State
United States	Institute for Human Health and Sports Science Research	High Point	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
High Point University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline functional status at 6 weeks	No
Primary	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.	Change from baseline pain level at 6 weeks	No
Secondary	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.	Change from baseline functional status at 6 weeks	No
Secondary	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	6 weeks	No
Secondary	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	Change from baseline general functional status at 6 weeks	No