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Assessment of Different Rehabilitation Treatments After a Partial Removal of the Meniscus (MENFIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Rovira i Virgili
Sponsor:
Collaborator:
Hospital Universitari Sant Joan de Reus
Information provided by (Responsible Party):
M. Rosa Nogués, University Rovira i Virgili
ClinicalTrials.gov Identifier:
NCT01775345
First received: January 22, 2013
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

To determine that rehabilitation treatment for a partial meniscectomy is more efficient in the functional recovery of the knee. Set in the fewest possible sessions, what treatment has benefits that last beyond the physical and what is the best cost-effectiveness.

It is expected that the combination of isotonic and isokinetic exercises in post-meniscectomy physiotherapy allows faster and less costly patient rehabilitate than the current isotonic protocol.


Condition Intervention Phase
Rehabilitation Post-meniscectomy
Procedure: Isotonic exercises
Procedure: Isokinetic exercises
Procedure: Isotonic and isokinetic exercises
Procedure: ST
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Assessment of Different Treatments of Muscle Strengthening in Post-meniscectomy Knee.

Resource links provided by NLM:


Further study details as provided by University Rovira i Virgili:

Primary Outcome Measures:
  • Maximum force peak in flexion of 60 º / seg and 180 º / seg, and extension of 60 º / seg and 180 º / seg. The assessment will be comparative. It will be realized in both the affected knee and the healthy knee. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    We will observe the maximum force peak in flexion of 60 º / seg and 180 º / seg, and extension of 60 º / seg and 180 º / seg. Both the valuation and the work of muscular involution with isokinetic exercises will fulfil with an isokinetic dynamometer Biodex 3.


Secondary Outcome Measures:
  • Knee functionality with the Lysholm Test. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    Questionnaire with 8 questions that the patient must answer with regard to the functionality of the affected knee. Maximum functionality 100 points.


Other Outcome Measures:
  • Degree of pain with the Visual Analogue Scale (VAS). [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    The patients must mark, in a scale from 0 to 10, the pain that they perceive in the affected knee, being 10 the maximum possible pain.

  • Metabolomic biomarkers [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    To identify changes in the metabolomic biomarkers related to inflammation process along the study, 3 plasma samples will be collected from patients: one week before the day of the surgical procedure, the 1st day of rehabilitation programme and at the end of the study.


Estimated Enrollment: 81
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Isotonic exercises + ST

This group will realize 20 sessions of muscular force work by means of isotonic exercises, that to the beginning will consist of 2 series of 10 repetitions to 60, 65 and 70 % of a maximum repetition (MR)(MR is the maximum resistance that a muscle can conquer).

Later, a gradual progression will be realized and the load will be increasing up to being able to realize, before the session 30: 2 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 2 series of 10 repetitions to 75 and 80 % of 1MR and one series of 6 repetitions to 85 and 90 % of 1MR.

Procedure: Isotonic exercises

20 sessions of muscular force work by means of isotonic exercises, that to the beginning will consist of 2 series of 10 repetitions to 60, 65 and 70 % of a MR.

Later, a gradual progression will be realized and the load will be increasing up to being able to realize, before the session 30: 2 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 2 series of 10 repetitions to 75 and 80 % of 1MR and one series of 6 repetitions to 85 and 90 % of 1MR.

Procedure: ST
Standard therapy: The 10 first rehabilitation sessions will be common (manual therapy, electrotherapy, proprioceptive reeducation, isometric exercises, bike exercise and cryotherapy)
Other Name: Standard therapy
Experimental: Isokinetic exercises + ST
This group will realize 20 sessions of muscular force work by means of isokinetic exercises, that to the beginning will consist of 2 series of 10 repetitions to 150, 180 and 210 º / seg in the first session and it will be increasing in a progressive and gradual way up to being able to realize, before the last session: 3 series of 15 repetitions to 180 º, 210 º and 240 º / seg, 2 series of 10 repetitions to 120 º and 150 º / seg and 2 series of 6 repetitions of 60 º and 90 º / seg.
Procedure: Isokinetic exercises
20 sessions of muscular force work by means of isokinetic exercises, that to the beginning will consist of 2 series of 10 repetitions to 150, 180 and 210 º / seg in the first session and it will be increasing in a progressive and gradual way up to being able to realize, before the last session: 3 series of 15 repetitions to 180 º, 210 º and 240 º / seg, 2 series of 10 repetitions to 120 º and 150 º / seg and 2 series of 6 repetitions of 60 º and 90 º / seg.
Procedure: ST
Standard therapy: The 10 first rehabilitation sessions will be common (manual therapy, electrotherapy, proprioceptive reeducation, isometric exercises, bike exercise and cryotherapy)
Other Name: Standard therapy
Experimental: Isotonic and isokinetic exercises + ST
This group will realize 20 sessions of muscular force work by means of isotonic and isokinetic exercises. To the beginning it will consist of 1 series of 10 repetitions to 150, 180 and 210 º / seg and 1 series of 10 repetitions to 60, 65 and 70 % of 1MR. A gradual progression will be realized up to reaching, before the last session, a load of: 2 series of 15 repetitions to 180, 210 and 240 º / seg, 1 series from 10 to 120 and 150 º / seg and 1 series of 6 repetitions to 60 and 90 º / seg, and 1 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 1 series of 10 repetitions to 75 and 80 % of 1MR and 1 series of 3 repetitions to 85 and 90 % of 1MR.
Procedure: Isotonic and isokinetic exercises
20 sessions of muscular force work by means of isotonic and isokinetic exercises. To the beginning it will consist of 1 series of 10 repetitions to 150, 180 and 210 º / seg and 1 series of 10 repetitions to 60, 65 and 70 % of 1 MR. A gradual progression will be realized up to reaching, before the last session, a load of: 2 series of 15 repetitions to 180, 210 and 240 º / seg, 1 series from 10 to 120 and 150 º / seg and 1 series of 6 repetitions to 60 and 90 º / seg, and 1 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 1 series of 10 repetitions to 75 and 80 % of 1MR and 1 series of 3 repetitions to 85 and 90 % of 1MR.
Procedure: ST
Standard therapy: The 10 first rehabilitation sessions will be common (manual therapy, electrotherapy, proprioceptive reeducation, isometric exercises, bike exercise and cryotherapy)
Other Name: Standard therapy

Detailed Description:

Longitudinal randomized single-blind study, 81 patients (27 per group; 3 groups), 18 to 60 years, underwent surgery meniscus and performing rehabilitation at the University Hospital Sant Joan de Reus. The first rehabilitation sessions will be common (manual therapy, electrotherapy, proprioceptive reeducation, isometric exercises, bike exercise and cryotherapy). From Session 10, will be randomized into 3 groups: group 1 protocol added isotonic exercises, group 2 isokinetic exercises and group 3 isotonic and isokinetic exercises.

The principal variable will be the maximum force peak of the muscle. An evaluation of other parameters such as knee function (Lysholm Test) and the degree of pain (VAS) will be performed.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women of between 18 and 60 years
  • Surgical Intervention: partial meniscectomy of the internal meniscus
  • Informed consent

Exclusion Criteria:

  • Re-meniscectomy
  • Associate injury of crossed ligaments
  • Degenerative osteoarthritis of knee degree the II, III or IV
  • Morbid obesity
  • Infectious diseases in the skin, cutaneous injuries and / or zones of hypoesthesia
  • Participants with malignant tumors
  • Participants with cognitive or sensory alterations
  • Volunteers who have taken part in a study in the last 3 months
  • Lack of collaboration of the patient
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775345

Contacts
Contact: Carme Casajuana, PT +34 977310300 ext 50630 ccasajuana@grupsagessa.com

Locations
Spain
Hospital Universitari Sant Joan Recruiting
Reus, Spain, 43201
Contact: Carme Casajuana, PT    +34 977310300 ext 50630    ccasajuana@grupsagessa.com   
Principal Investigator: Roser González, PT         
Principal Investigator: Anna Astilleros, PT         
Principal Investigator: Rosa Solà, MD         
Principal Investigator: Montse Giralt, MD         
Principal Investigator: Marta Romeu, SD         
Principal Investigator: Rosa Nogués, PhD         
Sponsors and Collaborators
University Rovira i Virgili
Hospital Universitari Sant Joan de Reus
Investigators
Study Director: Carme Casajuana, PT Hospital Universitari Sant Joan de Reus
  More Information

No publications provided

Responsible Party: M. Rosa Nogués, University Professor, University Rovira i Virgili
ClinicalTrials.gov Identifier: NCT01775345     History of Changes
Other Study ID Numbers: MENFIS
Study First Received: January 22, 2013
Last Updated: March 14, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by University Rovira i Virgili:
Partial meniscectomy
Physiotherapy
Isokinetics
Cost-effectiveness

ClinicalTrials.gov processed this record on November 20, 2014