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Conservative Treatment in Patients With Symptomatic Femoroacetabular Impingement

Primary Purpose

Symptomatic Femoroacetabular Impingement

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Neuromuscular training
Sponsored by
Schulthess Klinik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Femoroacetabular Impingement

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of unilateral symptomatic FAI according to clinical, radiographic and magnetic resonance imaging criteria
  • Living place: Canton of Zurich or neighbouring Cantons
  • Signed written informed consent to participate into the study

Exclusion Criteria:

  • Previous hip surgery
  • Any surgery to the lower limbs in the prior 6 months
  • Congenital/developmental dysplasia
  • Hip osteoarthritis
  • Initiation of opioid analgesia and corticosteroid injection for hip pain within the prior 30 days
  • BMI >35 kg/m2
  • Significant cardiorespiratory diseases

Sites / Locations

  • Schulthess Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neuromuscular training

Arm Description

Outcomes

Primary Outcome Measures

Hip Function as measured using the Hip Outcome Score questionnaire
Hip Function was assessed using the Hip Outcome Score. The Hip Outcome score is a questionnaire used to evaluate hip function during daily and sport activities. Two independent scores are obtained: one for activities of daily living and one for sport activities.

Secondary Outcome Measures

Hip Muscle Strength as measured using dynamometry
Hip abduction, adduction, internal rotation and external rotation isometric maximal voluntary contraction strength is evaluated with hand-held dynamometry. Hip flexion and extension isometric maximal voluntary contraction strength is evaluated with isokinetic dynamometry.
Movement Control Quality as measured using a visual rating scale
Overall body movement pattern quality is visually assessed during the performance of 5 lower extremity functional tests (single-leg squat, lunge, hop lunge, single-leg bridge, single-leg ventral plank).

Full Information

First Posted
January 29, 2015
Last Updated
June 14, 2019
Sponsor
Schulthess Klinik
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1. Study Identification

Unique Protocol Identification Number
NCT02368483
Brief Title
Conservative Treatment in Patients With Symptomatic Femoroacetabular Impingement
Official Title
The Effectiveness of Neuromuscular Training of the Lower Limb Muscles in Reducing the Hip Symptoms in Patients With Symptomatic Femoroacetabular Impingement: a Prospective Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schulthess Klinik

4. Oversight

5. Study Description

Brief Summary
This is a single-group, prospective, intervention study. A total of 30 participants with unilateral symptomatic femoroacetabular impingement will be included into the study. The intervention consists in neuromuscular training for the lower limb muscles (12 weeks, 2 times/week supervised training, 2 times/week home training). The training includes physical exercises routinely used worldwide in clinical settings. No control intervention group was included into the study because nowadays there is no standard conservative treatment for patients with symptomatic femoroacetabular impingement. Assessments will be performed at (1) baseline, (2) mid-intervention, (3) end-intervention, and (4) follow-up. Clinical, functional, neuromuscular and self-reported parameters will be collected during assessments.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Neuromuscular training
Intervention Description
Neuromuscular training for the hip and lower limb muscles.The training program is divided into 3 phases, and includes specific exercises for improving the hip range of motion, muscle strength of the hip and lower limb muscles, as well as the trunk stability and coordination. The intervention lasts 12 weeks. Patients will train 2 times/week with a physical therapist and 2 times/weeks alone at home.
Primary Outcome Measure Information:
Title
Hip Function as measured using the Hip Outcome Score questionnaire
Description
Hip Function was assessed using the Hip Outcome Score. The Hip Outcome score is a questionnaire used to evaluate hip function during daily and sport activities. Two independent scores are obtained: one for activities of daily living and one for sport activities.
Time Frame
Change from Baseline in Hip Function at 12 weeks
Secondary Outcome Measure Information:
Title
Hip Muscle Strength as measured using dynamometry
Description
Hip abduction, adduction, internal rotation and external rotation isometric maximal voluntary contraction strength is evaluated with hand-held dynamometry. Hip flexion and extension isometric maximal voluntary contraction strength is evaluated with isokinetic dynamometry.
Time Frame
Change from Baseline in Hip Muscle Strength at 12 weeks
Title
Movement Control Quality as measured using a visual rating scale
Description
Overall body movement pattern quality is visually assessed during the performance of 5 lower extremity functional tests (single-leg squat, lunge, hop lunge, single-leg bridge, single-leg ventral plank).
Time Frame
Change from Baseline in Movement Control Quality at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of unilateral symptomatic FAI according to clinical, radiographic and magnetic resonance imaging criteria Living place: Canton of Zurich or neighbouring Cantons Signed written informed consent to participate into the study Exclusion Criteria: Previous hip surgery Any surgery to the lower limbs in the prior 6 months Congenital/developmental dysplasia Hip osteoarthritis Initiation of opioid analgesia and corticosteroid injection for hip pain within the prior 30 days BMI >35 kg/m2 Significant cardiorespiratory diseases
Facility Information:
Facility Name
Schulthess Clinic
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
30133164
Citation
Casartelli NC, Bizzini M, Maffiuletti NA, Sutter R, Pfirrmann CW, Leunig M, Naal FD. Exercise Therapy for the Management of Femoroacetabular Impingement Syndrome: Preliminary Results of Clinical Responsiveness. Arthritis Care Res (Hoboken). 2019 Aug;71(8):1074-1083. doi: 10.1002/acr.23728. Epub 2019 Jul 9.
Results Reference
derived

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Conservative Treatment in Patients With Symptomatic Femoroacetabular Impingement

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