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Diagnosis and Treatment of Patients With Femoroacetabular Impingement Syndrome

Primary Purpose

Femoroacetabular Impingement

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Physiotherapist-led treatment
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoroacetabular Impingement

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • All part of the study is conducted at Department of Orthopedic Department, Hvidovre HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FAIS with intra-articular hip pain

FAIS without intra-articular hip pain

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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
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
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)
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.
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).
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.

Full Information

First Posted
February 18, 2019
Last Updated
July 27, 2020
Sponsor
Hvidovre University Hospital
Collaborators
La Trobe University, Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03846817
Brief Title
Diagnosis and Treatment of Patients With Femoroacetabular Impingement Syndrome
Official Title
Optimization of the Diagnostic Process and Physiotherapist-led Treatment of Patients With Femoroacetabular Impingement Syndrome: a Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
March 12, 2021 (Anticipated)
Study Completion Date
March 12, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
La Trobe University, Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoroacetabular Impingement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
Participants will be blinded to the potential value of the diagnostic findings, such as response to intra-articular hip injection. Outcome assessor will be blinded to diagnostic findings, such as response to intra-articular hip injection. Care Provider (Physiotherapist supervising the intervention) will be blinded to diagnostic findings, such as response to intra-articular hip injection.
Allocation
Non-Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FAIS with intra-articular hip pain
Arm Type
Experimental
Arm Description
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.
Arm Title
FAIS without intra-articular hip pain
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physiotherapist-led treatment
Other Intervention Name(s)
Exercise-based treatment
Intervention Description
12-week of semi-standardized, progressive physiotherapist-led treatment aiming to increase hip muscle strength and load capacity.
Primary Outcome Measure Information:
Title
Change in HAGOS Sport subscale
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in HAGOS subscales
Description
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).
Time Frame
12 weeks
Title
Change in hip peak torque
Description
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.
Time Frame
12 weeks
Title
Change in hip rate of torque development
Description
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
Time Frame
12 weeks
Title
Change in single leg hop performance
Description
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
Time Frame
12 weeks
Title
Change in isometric adduction squeeze torque
Description
Between-group (intra-articular pain vs. no intra-articular pain) difference in change in peak isometric hip adduction squeeze torque (Nm/kg)
Time Frame
12 weeks
Title
Return to sport
Description
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.
Time Frame
12 weeks
Title
Treatment expectations and fulfilment of expectations
Description
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).
Time Frame
12 weeks
Title
Patient acceptable symptom state
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lasse Ishøi, PhD student
Phone
20438110
Email
lasse.ishoei@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lasse Ishøi
Organizational Affiliation
Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Per Hölmich
Organizational Affiliation
Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kristian Thorborg
Organizational Affiliation
Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joanne Kemp
Organizational Affiliation
La Trobe Sport and Exercise Medicine Research Centre, La Trobe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael Reiman
Organizational Affiliation
Duke University Medical Center, Duke University
Official's Role
Study Chair
Facility Information:
Facility Name
All part of the study is conducted at Department of Orthopedic Department, Hvidovre Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lasse Ishøi
Phone
0045 20438110
Email
lasse.ishoei@gmail.com
First Name & Middle Initial & Last Name & Degree
Lasse Ishøi
First Name & Middle Initial & Last Name & Degree
Per Hôlmich

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Diagnosis and Treatment of Patients With Femoroacetabular Impingement Syndrome

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