Conservative Intervention of Femoroacetabular Impingement Syndrome

Femoroacetabular Impingement Clinical Trial

Official title:

Conservative Intervention of Femoroacetabular Impingement Syndrome: A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02706756
• Other study ID #: Pro00069234
• Status: Withdrawn
• Phase: N/A
• First received: March 8, 2016
• Last updated: February 3, 2017
• Start date: March 2016
• Est. completion date: March 2018

Study information

• Verified date: February 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. Purpose: 1) compare three conservative treatment approaches for subjects with femoroacetabular impingement syndrome (FAI), and 2) analyze functional outcome comparatively across groups.

2. Interventions will be provided based on randomized assignment. Group 1 will receive treatment based on identified impairments and treated twice weekly to address said impairments with hip manual therapy and exercise, as well as a prescriptive exercise for strengthening and mobility of the hip. Group 2 will receive only the prescriptive exercise program. Group 3 will be a control group (supervised neglect)

3. Primary outcomes data analysis will involve a mixed design (repeated measures) ANOVA for assessment of the primary outcome measure of the HAGOS. Secondary analyses will include chi square analyses (PASS, surgery at 6 months, adverse events), ANCOVA (PPMs, and expectations measures), or other appropriate comparative measures. None of the proposed treatment is considered outside of 'standard of practice'.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Individuals age 18 to 60 years,

• diagnosed with FAI by an orthopedic surgeon and exhibiting

• hip/groin symptoms for at least 3 months (symptomatic); and

• signs, symptoms and imaging findings conducive to FAI will be recruited from a surgical practice of an orthopedic surgeon in Durham, North Carolina.

Exclusion Criteria:

• subjects that have radiographic evidence of hip osteoarthritis that is more than mild in severity defined as Tonnis >grade 1 or Kellgren-Lawrence >2;

• have other concurrent injury/conditions that will affect their ability to participate in the rehabilitation program and/or assessment procedures;

• exhibit hip dysplasia (center edge angle <20 degrees on AP radiograph

• are unable to attend a study physiotherapist or participate in the rehabilitation program if randomized to the PT group;

• are unable to understand English.

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement

Intervention

Other:
• Manual therapy
Hip joint and spine manual therapy techniques applied toward the impairments of the subject.
• Exercise
Prescriptive exercise program of self-mobilization and/or strengthening program to address impairments of the subject.
• Education and advice
All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care).
• Supervised neglect
Monitoring of group without formal intervention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Did subject elect to undergo surgery?	Determination of whether the subject had surgery for femoroacetabular impingement or not	up to 6 months after intervention
Secondary	Change in Stanford Expectations of Treatment Scale (SETS)	subject expectation of treatment	initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Secondary	Change in Patient Acceptable Symptom State (PASS)	subject acceptance of what their current symptom state is	initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Secondary	Change in numeric pain rating scale		initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Secondary	Change in Hip and Groin Outcome Score		initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Secondary	Change in Single leg stance (SLS)	measure of single leg balance and stability	initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Secondary	Change in Lower Quarter Y Balance Test (YBT-LQ)	measure of single leg balance, strength and coordination	initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Secondary	Change in Single Leg Anteroposterior Hop	Measure of single leg balance, strength, power and coordination	initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Secondary	Change in Standing Hip Internal Rotation Range-of-Motion	Measure of single leg weight-bearing range of motion	initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit
Secondary	Change in Complications/Adverse Events of assigned treatment		initial visit, 4 to 6 weeks after initial visit, and 6 months after initial visit