Diagnosis and Treatment of Patients With Femoroacetabular Impingement Syndrome

Optimization of the Diagnostic Process and Physiotherapist-led Treatment of Patients With Femoroacetabular Impingement Syndrome: a Prospective Cohort Study

This prospective study with a two-group comparison design investigates the effectiveness of 12-weeks of semi-structured and supervised physiotherapist-led treatment on self-reported hip and groin function in patients with femoroacetabular impingement syndrome with and without intra-articular hip pain. Determination of intra-articular hip pain is based on pain relief following an ultrasound-guided intra-articular anesthetic hip injection performed prior to commencing treatment.

Study Overview

• Status: Unknown
• Conditions: Femoroacetabular Impingement
• Intervention / Treatment: Other: Physiotherapist-led treatment

Detailed Description

The treatment of femoroacetabular impingement syndrome (FAIS) consists of wait-and-see, physiotherapist-led treatment, and/or hip surgery. The primary indication for hip surgery is based on imaging findings, however, limited correlation has been observed between such findings and hip symptoms. As patients with FAIS often show physical impariments, such as impaired hip muscle function, physiotherapist-led treatment aiming to address such factors may be effective in improving hip function and pain in some patients. However, several factors may confound the effect of physiotherapist-led treatement of FAIS, such as whether the patient presents with intra-articular hip joint pain or not.

Thus, the purpose of this prospective study with a two-group comparison design is to investigate the effect of 12-weeks of physiotherapist-led treatment on self-reported hip and groin function, measured with the Copenhagen Hip and Groin Outcome Score (HAGOS), in subjects diagnosed with FAIS, but with and without intra-articular hip pain. Determination of intra-articular hip pain is based on the response to an ultrasound-guided intra-articular anesthetic hip injection performed prior to commencing treatment.

Subjects diagnosed with FAIS based on symptoms, clinical signs and imaging findings will be prospectively recruited from a specialized outpatient hip and groin clinic at Hvidovre Hospital. Following inclusion subjects undergo 12-weeks of semi-structured and supervised physiotherapist-led treatment. The primary outcome measure is the between-group (intra-articular pain vs. no intra-articular pain) difference in mean change of the HAGOS sport subscale from baseline (week 0) to follow-up (week 12).

The primary outcome measure will be publised in the primary paper, which will also include information on between-group difference in change in hip muscle strength and single-leg hop performance as secondary outcome measures.

Secondary papers will be reported with a clear reference to the primary paper.

The sample size calculation is based on the primary outcome measure, being the between-group (intra-articular pain vs. no intra-articular pain) difference in change in the HAGOS Sport subscale following 12 weeks of physiotherapist-led treatment. Based on an expected 1/1 recruitment ratio between subjects with and without intra-articular hip pain and a clinically relevant between-group contrast in change of 15 points corresponding to a moderate effect size 0.6 (Cohen's d), a power and alpha value of 80% and 0.05, respectively, 44 subjects in each group is adequate (G*power software, v.3.1, Heinrich-Heine-Universität, Düsseldorf, Germany). To minimize the risk of underpowering the study in case of uneven allocation to groups, based on the intra-articular anesthetic hip injection, inclusion of participants will continue until a minimum of 55 (44 including 25% dropouts in each group) subjects has been recruited in each group. A blinded member of the research team will be responsible for monitoring this.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lasse Ishøi, PhD student; Phone Number: 20438110; Email: lasse.ishoei@gmail.com

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • All part of the study is conducted at Department of Orthopedic Department, Hvidovre Hospital
    • Contact: Lasse Ishøi; Phone Number: 0045 20438110; Email: lasse.ishoei@gmail.com
    • Principal Investigator: Lasse Ishøi
    • Sub-Investigator: Per Hôlmich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Activity-related longstanding hip and/or groin pain for >3 months
• Known anterior and/or medial groin pain during the FADIR test with a pain severity of ≥2/10 on NRS.
• Radiological findings on plain radiographs of cam morphology defined as alpha angle >55° on a lateral view.

Exclusion Criteria:

• Inguinal-related groin pain diagnosed according to Doha Agreement.
• Pubic-related groin pain diagnosed according to Doha Agreement.
• Evidence of pre-existing hip osteoarthritis, defined as a joint space width <3 mm at the lateral sourcil on anterior-posterior pelvic radiograph.
• Previous hip pathology such as Perthes' disease, slipped upper femoral epiphysis, hip dysplasia defined as a Lateral Center Edge Angle <25°, or avascular necrosis.
• Other causes of hip and groin pain identified by the orthopedic surgeon during the clinical examination, such as stress fracture of the femoral neck, referred pain from the facet joint, referred pain from the sacroiliac joint, or other competing diagnosis (rheumatoid arthritis, cancer etc.)
• Previous hip injury such as acetabular fracture, hip dislocation, or femoral neck fracture.
• Previous intra- or extra-articular hip surgery.
• Pregnant.
• Intra-articular steroid hip injection during the preceding 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FAIS with intra-articular hip pain; 12-week of semi-standardized, progressive physiotherapist-led treatment supervised by a physiotherapist blinded to clinical and objective findings. The treatment program will consist of one weekly exercise training session at Hvidovre Hospital supervised by a physiotherapist and twice-weekly unsupervised exercise training sessions performed at home for a consecutive period of 12-weeks (12 supervised sessions; 24 unsupervised sessions). In conjunction with the physiotherapist-led treatment, participants will be advised to modify potential aggravating physical activitie, and gradually increase their level of activity during the treatment period.	Other: Physiotherapist-led treatment; 12-week of semi-standardized, progressive physiotherapist-led treatment aiming to increase hip muscle strength and load capacity.; Other Names: Exercise-based treatment
Experimental: FAIS without intra-articular hip pain; 12-week of semi-standardized, progressive physiotherapist-led treatment supervised by a physiotherapist blinded to clinical and objective findings. The treatment program will consist of one weekly exercise training session at Hvidovre Hospital supervised by a physiotherapist and twice-weekly unsupervised exercise training sessions performed at home for a consecutive period of 12-weeks (12 supervised sessions; 24 unsupervised sessions). In conjunction with the physiotherapist-led treatment, participants will be advised to modify potential aggravating physical activitie, and gradually increase their level of activity during the treatment period.	Other: Physiotherapist-led treatment; 12-week of semi-standardized, progressive physiotherapist-led treatment aiming to increase hip muscle strength and load capacity.; Other Names: Exercise-based treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HAGOS Sport subscale	The primary outcome measure is the between-group (intra-articular pain vs. no intra-articular pain) difference in change in self-reported hip and groin function, measured with the Copenhagen Hip and Groin Outcome Score (HAGOS) Sport subscale from baseline to follow-up in subjects diagnosed with FAIS. The HAGOS Sport subcale is scored on a scale from 0 (extreme hip and groin problems) to 100 (no hip and groin problems).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HAGOS subscales	Between-group (intra-articular pain vs. no intra-articular pain) difference in change in self-reported hip and groin function, measured with the Copenhagen Hip and Groin Outcome Score (HAGOS; all subscales exept Sport) from baseline to follow-up in subjects diagnosed with FAIS. The HAGOS subcales are scored on a scale from 0 (extreme hip and groin problems) to 100 (no hip and groin problems).	12 weeks
Change in hip peak torque	Between-group (intra-articular pain vs. no intra-articular pain) difference in change in peak isometric hip torque (Nm/kg) of abduction, adduction, extension, and flexion.	12 weeks
Change in hip rate of torque development	Between-group (intra-articular pain vs. no intra-articular pain) difference in change in 0-100 ms and 0-200 ms rate of torque development (Nm/s/kg) of abduction, adduction, extension, and flexion	12 weeks
Change in single leg hop performance	Between-group (intra-articular pain vs. no intra-articular pain) difference in change in reactive strength index obtained during a single leg drop jump test	12 weeks
Change in isometric adduction squeeze torque	Between-group (intra-articular pain vs. no intra-articular pain) difference in change in peak isometric hip adduction squeeze torque (Nm/kg)	12 weeks
Return to sport	Obtained at follow-up (week 12) using a return to sport questionnaire to determine the proportion the patients who have returned to preinjury sport at preinjury level including optimal sport performance in each group (intra-articular pain vs. no intra-articular pain). The outcome will be reported as proportion/frequency.	12 weeks
Treatment expectations and fulfilment of expectations	Treatment expectations and fulfilment of expectations will be obtained using a modified version of a questionnaire previously used and validated for patients undergoing spine surgery, which has been used previously to assess treatment expectations and fulfilment of treatment expectations in patients undergoing surgery for FAIS. Expectations and fulfilment are assessed on a 5-point Likert scale as: much better (0), better (1), somewhat better (2), unchanged (3), worse (4).	12 weeks
Patient acceptable symptom state	Patient Acceptable Symptom State (PASS) will be assessed at 12-weeks follow-up. The PASS defines a level of symptoms that discriminates between feeling well and unwell. Subjects will be instructed to answer the following question with yes/no: ''Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?'' The outcome will be reported as proportion/frequency.	12 weeks

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: Duke University; La Trobe University
• Investigators: Principal Investigator: Lasse Ishøi, Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital; Study Director: Per Hölmich, Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital; Study Director: Kristian Thorborg, Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital; Study Chair: Joanne Kemp, La Trobe Sport and Exercise Medicine Research Centre, La Trobe University; Study Chair: Michael Reiman, Duke University Medical Center, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2019
• Primary Completion (Anticipated): March 12, 2021
• Study Completion (Anticipated): March 12, 2021

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Femoracetabular Impingement
• Other Study ID Numbers: Physio treatment FAI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No