Conservative Management of Femoroacetabular Impingement

NCT01814124 | Completed

• 1 other identifier: 201207-116
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoroacetabular Impingement

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• Functional Squat

  Change from baseline functional status at 6 weeks

• Global Rating of Change Scale

  6 weeks

• Lower Extremity Functional Scale

  Change from baseline general functional status at 6 weeks

Study Arms (2)

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

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

Other: Manual therapy plus exercise; Other: Advice and home exercise

Interventions

Manual therapy plus exercise OTHER

Manual Therapy Plus Exercise

Advice and home exercise OTHER

Advice and home exercise; Manual Therapy Plus Exercise

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• High Point University: lead

Study Sites (1)

Institute for Human Health and Sports Science Research

High Point, North Carolina, 27262, United States

Location

Related Publications (1)

• 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.

  PMID: 26795448 DERIVED

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Musculoskeletal Manipulations; Exercise; Counseling

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 19, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 25, 2016

Record last verified: 2016-02

Locations

US (1)