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Specific Protocoled Physiotherapy Treatment for Subjects Surgically Treated for Femoroacetabular Syndrome (FAI)

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ClinicalTrials.gov Identifier: NCT03959254
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
SERGIO MONTERO NAVARRO, Cardenal Herrera University

Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date June 20, 2019
Actual Study Start Date  ICMJE June 19, 2019
Actual Primary Completion Date June 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Hip Range of Mobility [ Time Frame: 14 weeks ]
    The range of mobility is evaluated by goniometry.
  • Intensity of pain [ Time Frame: 14 weeks ]
    The intensity of pain is evaluated by Visual Analogue Scale (VAS). The values are between 0 (absence of pain) to 10 (maximum intensity pain)
  • Functionality of the hip [ Time Frame: 14 weeks ]
    Modified Harris Hip Score Questionnaire (mHHS) is used to determine the functionality of the hip. The values are between 0 (lowest functionality) and 100 (normal function). The sub scales the subscales that compose it are hip pain (from 0 to 44), lameness in walking (from 0 to 11), need for walking aids (0 to 11), walked distance (0 to 11), ability to going up or down stairs (0 to 4), putting on shoes (0 to 4), sitting down without pain (0 to 5) and possibility of using public transport (0 to 1), with 0 being always the worst value.
  • Fabere Test [ Time Frame: 14 weeks ]
    The patient's hip is flexed, abducted and externally rotated by placing the external malleolus on the knee of the contralateral leg. The pelvis is stabilized and an overpressure is applied to the inside of the knee. It is positive if the pain in the buttock or groin is reproduced. Test with inter-evaluator reliability in Kappa values (95% CI) of 0.60
  • Faddir Test [ Time Frame: 14 weeks ]
    Flexion, adduction and internal rotation test. The supine patient, the evaluator patiently brings the patient's hip up to 100º flexion and adduction while applying internal rotation. It is positive if pain in the groin is reproduced. Test with inter-evaluator reliability in Kappa values of 0.48
  • Ober test [ Time Frame: 14 weeks ]
    Patient in lateral decubitus position. The evaluator flexes the knee that is evaluated at 90º and abducts and extends the hip until it is level with the trunk. The evaluator lets the gravity bring the hip on aduction as possible. Test with inter-evaluator reliability of 0.90
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03959254 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Specific Protocoled Physiotherapy Treatment for Subjects Surgically Treated for Femoroacetabular Syndrome
Official Title  ICMJE EFFECTIVENESS OF A PROTOCOLIZED TREATMENT OF SPECIFIC PHYSIOTHERAPY FOR SUBJECTS SURGICALLY OPERATED BY ARTHROSCOPY FOR FEMOROACETABULAR SYNDROME
Brief Summary Physiotherapy treatment protocols described in the bibliography after hip surgery are most of them nonspecific. An experimental study is proposed to determine the effectiveness of a protocolized treatment of physiotherapy in the postoperative treatment of femoroacetabular impingement treated by arthroscopy. This study tries to adapt the non-specific post-surgical physiotherapy treatment protocols of the hip to the characteristics of the femoroacetabular impingement and its arthroscopic surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hip Injuries
Intervention  ICMJE Procedure: Physiotherapy post-surgical protocol for femoroacetabular impingement

The intervention is structured in 14 weeks. Gradually the level of demand for the exercises increases over the weeks. Isometric and concentric exercises of the affected muscle groups are combined in the first weeks, as well as mobilization exercises of the joints involved in the injury. In addition, the time of permanence in a sitting, prone or supine position is prescribed. The return to the march and activities of daily life are staggered.

The number of series and repetitions to be performed is described in each exercise.

Study Arms  ICMJE
  • Experimental: Intervention Group
    Application of a protocol of active exercises for recovery after arthroscopic hip surgery, adapted to the femoroacetabular shock characteristics.
    Intervention: Procedure: Physiotherapy post-surgical protocol for femoroacetabular impingement
  • Active Comparator: Control Group
    Usual post-surgical general guidelines for hip interventions described by Gocen et al
    Intervention: Procedure: Physiotherapy post-surgical protocol for femoroacetabular impingement
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2019
Actual Primary Completion Date June 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Having suffered hip / groin pain for at least 3 months.
  • Be a patient diagnosed with femoroacetabular syndrome by an orthopedic surgeon based on symptoms, clinical signs and diagnostic imaging.
  • To have signed the informed consent.
  • Have time available to follow a 14-week physiotherapy treatment program.
  • Be programmed for hip arthroscopy.
  • Be able to speak and understand the Spanish language.
  • Be between 18 and 50 years of age.

Exclusion Criteria:

  • To have received physiotherapy treatment in the last three months.
  • Having previously received hip surgery.
  • Subjects with previous deformities in the femur that severely alter joint mobility such as Perthes disease, gliding of the upper femoral epiphysis or avascular necrosis, acetabular fracture, hip dislocation or fracture of the femoral neck.
  • Evidence of preexisting osteoarthritis, defined as Tonnis grade> 2
  • Subjects with previous deformities in the pelvis that severely alter joint mobility.
  • Any other cardiovascular, psychological and / or cognitive diagnosed pathology that impedes the correct understanding of the study and prevents objective study variables.
  • Subjects that are under the effects of anesthetics or muscle relaxants that mask the sensation of the patient before the techniques of the study.
  • Professional athletes.
  • Subjects in which hip arthroscopy is contraindicated.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: SERGIO MONTERO NAVARRO, PhD 0034965426486 ext 67516 jmbotella@uchceu.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959254
Other Study ID Numbers  ICMJE CEU UCH FAI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SERGIO MONTERO NAVARRO, Cardenal Herrera University
Study Sponsor  ICMJE Cardenal Herrera University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cardenal Herrera University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP