Back to results

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

Primary Purpose

Hip Injuries

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Physiotherapy post-surgical protocol for femoroacetabular impingement

About this trial

This is an interventional treatment trial for Hip Injuries

Eligibility Criteria

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

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.

Sites / Locations

Universidad CEU Cardenal Herrera
Ceu Cardenal Herrera University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

Application of a protocol of active exercises for recovery after arthroscopic hip surgery, adapted to the femoroacetabular shock characteristics.

Usual post-surgical general guidelines for hip interventions described by Gocen et al

Outcomes

Primary Outcome Measures

Hip Range of Mobility

The range of mobility is evaluated by goniometry.

Intensity of pain

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

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

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03959254

First Posted

May 16, 2019

Last Updated

December 18, 2019

Sponsor

Cardenal Herrera University

1. Study Identification

Unique Protocol Identification Number

NCT03959254

Brief Title

Specific Protocoled Physiotherapy Treatment for Subjects Surgically Treated for Femoroacetabular Syndrome

Acronym

FAI

Official Title

EFFECTIVENESS OF A PROTOCOLIZED TREATMENT OF SPECIFIC PHYSIOTHERAPY FOR SUBJECTS SURGICALLY OPERATED BY ARTHROSCOPY FOR FEMOROACETABULAR SYNDROME

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

June 19, 2019 (Actual)

Primary Completion Date

June 19, 2019 (Actual)

Study Completion Date

December 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cardenal Herrera University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Hip Injuries

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

Application of a protocol of active exercises for recovery after arthroscopic hip surgery, adapted to the femoroacetabular shock characteristics.

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Usual post-surgical general guidelines for hip interventions described by Gocen et al

Intervention Type

Procedure

Intervention Name(s)

Physiotherapy post-surgical protocol for femoroacetabular impingement

Intervention Description

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 Measure Information:

Title

Hip Range of Mobility

Description

The range of mobility is evaluated by goniometry.

Time Frame

14 weeks

Title

Intensity of pain

Description

The intensity of pain is evaluated by Visual Analogue Scale (VAS). The values are between 0 (absence of pain) to 10 (maximum intensity pain)

Time Frame

14 weeks

Title

Functionality of the hip

Description

Time Frame

14 weeks

Title

Fabere Test

Description

Time Frame

14 weeks

Title

Faddir Test

Description

Time Frame

14 weeks

Title

Ober test

Description

Time Frame

14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Universidad CEU Cardenal Herrera

City

Valencia

State/Province

Moncada

ZIP/Postal Code

46113

Country

Spain

Facility Name

Ceu Cardenal Herrera University

City

Moncada

State/Province

Valencia

ZIP/Postal Code

46113

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

19089521

Citation

Smith-Petersen MN. The classic: Treatment of malum coxae senilis, old slipped upper femoral epiphysis, intrapelvic protrusion of the acetabulum, and coxa plana by means of acetabuloplasty. 1936. Clin Orthop Relat Res. 2009 Mar;467(3):608-15. doi: 10.1007/s11999-008-0670-0. Epub 2008 Dec 17.

Results Reference

background

PubMed Identifier

15043096

Citation

Leunig M, Podeszwa D, Beck M, Werlen S, Ganz R. Magnetic resonance arthrography of labral disorders in hips with dysplasia and impingement. Clin Orthop Relat Res. 2004 Jan;(418):74-80. doi: 10.1097/00003086-200401000-00013.

Results Reference

background

PubMed Identifier

29893223

Citation

Griffin DR, Dickenson EJ, Wall PDH, Achana F, Donovan JL, Griffin J, Hobson R, Hutchinson CE, Jepson M, Parsons NR, Petrou S, Realpe A, Smith J, Foster NE; FASHIoN Study Group. Hip arthroscopy versus best conservative care for the treatment of femoroacetabular impingement syndrome (UK FASHIoN): a multicentre randomised controlled trial. Lancet. 2018 Jun 2;391(10136):2225-2235. doi: 10.1016/S0140-6736(18)31202-9. Epub 2018 Jun 1.

Results Reference

background

PubMed Identifier

28900574

Citation

Kuhns BD, Weber AE, Batko B, Nho SJ, Stegemann C. A FOUR-PHASE PHYSICAL THERAPY REGIMEN FOR RETURNING ATHLETES TO SPORT FOLLOWING HIP ARTHROSCOPY FOR FEMOROACETABULAR IMPINGEMENT WITH ROUTINE CAPSULAR CLOSURE. Int J Sports Phys Ther. 2017 Aug;12(4):683-696.

Results Reference

background

PubMed Identifier

27629405

Citation

Wall PD, Dickenson EJ, Robinson D, Hughes I, Realpe A, Hobson R, Griffin DR, Foster NE. Personalised Hip Therapy: development of a non-operative protocol to treat femoroacetabular impingement syndrome in the FASHIoN randomised controlled trial. Br J Sports Med. 2016 Oct;50(19):1217-23. doi: 10.1136/bjsports-2016-096368.

Results Reference

background

PubMed Identifier

24571824

Citation

Bennell KL, O'Donnell JM, Takla A, Spiers LN, Hunter DJ, Staples M, Hinman RS. Efficacy of a physiotherapy rehabilitation program for individuals undergoing arthroscopic management of femoroacetabular impingement - the FAIR trial: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2014 Feb 26;15:58. doi: 10.1186/1471-2474-15-58.

Results Reference

background

PubMed Identifier

15180117

Citation

Gocen Z, Sen A, Unver B, Karatosun V, Gunal I. The effect of preoperative physiotherapy and education on the outcome of total hip replacement: a prospective randomized controlled trial. Clin Rehabil. 2004 Jun;18(4):353-8. doi: 10.1191/0269215504cr758oa.

Results Reference

background

PubMed Identifier

29607766

Citation

Kemp JL, Coburn SL, Jones DM, Crossley KM. The Physiotherapy for Femoroacetabular Impingement Rehabilitation STudy (physioFIRST): A Pilot Randomized Controlled Trial. J Orthop Sports Phys Ther. 2018 Apr;48(4):307-315. doi: 10.2519/jospt.2018.7941.

Results Reference

background

Links:

URL

http://www.uchceu.es

Description

The University CEU-Cardenal Herrera is the first private university in the Valencian Community. It belongs to the Foundation San Pablo CEU, the leading educational organization in Spain with three Universities all over Spain.

Learn more about this trial

Specific Protocoled Physiotherapy Treatment for Subjects Surgically Treated for Femoroacetabular Syndrome

We'll reach out to this number within 24 hrs