Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Hip Injuries Procedure: Physiotherapy post-surgical protocol for femoroacetabular impingement Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EFFECTIVENESS OF A PROTOCOLIZED TREATMENT OF SPECIFIC PHYSIOTHERAPY FOR SUBJECTS SURGICALLY OPERATED BY ARTHROSCOPY FOR FEMOROACETABULAR SYNDROME
Actual Study Start Date : June 19, 2019
Actual Primary Completion Date : June 19, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
Application of a protocol of active exercises for recovery after arthroscopic hip surgery, adapted to the femoroacetabular shock characteristics.
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.


Active Comparator: Control Group
Usual post-surgical general guidelines for hip interventions described by Gocen et al
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.





Primary Outcome Measures :
  1. Hip Range of Mobility [ Time Frame: 14 weeks ]
    The range of mobility is evaluated by goniometry.

  2. 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)

  3. 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.

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959254


Contacts
Layout table for location contacts
Contact: SERGIO MONTERO NAVARRO, PhD 0034965426486 ext 67516 jmbotella@uchceu.es

Locations
Layout table for location information
Spain
Universidad CEU Cardenal Herrera Recruiting
Valencia, Moncada, Spain, 46113
Ceu Cardenal Herrera University Recruiting
Moncada, Valencia, Spain, 46113
Contact: JOSE BOTELLA RICO, PhD    +34965426486 ext 67516    jm.botella@uchceu.es   
Principal Investigator: JOSE BOTELLA RICO, PhD         
Sponsors and Collaborators
Cardenal Herrera University
  Study Documents (Full-Text)

Documents provided by SERGIO MONTERO NAVARRO, Cardenal Herrera University:
Informed Consent Form  [PDF] May 20, 2019


Additional Information:
Publications:

Layout table for additonal information
Responsible Party: SERGIO MONTERO NAVARRO, Principal Investigator, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT03959254     History of Changes
Other Study ID Numbers: CEU UCH FAI
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Hip Injuries
Wounds and Injuries