Diagnosis and Treatment of Patients With Femoroacetabular Impingement Syndrome

NCT03846817 | Unknown DMC

• 1 other identifier: Physio treatment FAI
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoroacetabular Impingement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in HAGOS subscales

  12 weeks

• Change in hip peak torque

  12 weeks

• Change in hip rate of torque development

  12 weeks

• Change in single leg hop performance

  12 weeks

• Change in isometric adduction squeeze torque

  12 weeks

Study Arms (2)

FAIS with intra-articular hip pain

EXPERIMENTAL

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

FAIS without intra-articular hip pain

EXPERIMENTAL

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

Interventions

Physiotherapist-led treatment OTHER

12-week of semi-standardized, progressive physiotherapist-led treatment aiming to increase hip muscle strength and load capacity.

Also known as: Exercise-based treatment

FAIS with intra-articular hip pain; FAIS without intra-articular hip pain

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• La Trobe University: collaborator
• Duke University: collaborator

Study Sites (1)

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

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

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

Study Officials

• Lasse Ishøi

  Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

• Joanne Kemp

  La Trobe Sport and Exercise Medicine Research Centre, La Trobe University

  STUDY CHAIR

• Michael Reiman

  Duke University Medical Center, Duke University

  STUDY CHAIR

Central Study Contacts

Lasse Ishøi, PhD student

CONTACT

20438110; lasse.ishoei@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 20, 2019
• Study Start: March 12, 2019
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

DK (1)