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

Assessment of Different Treatments of Muscle Strengthening in Post-meniscectomy Knee.

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.

Study Overview

• Status: Unknown
• Conditions: Rehabilitation Post-meniscectomy
• Intervention / Treatment: Procedure: Isotonic exercises; Procedure: ST; Procedure: Isokinetic exercises; Procedure: Isotonic and isokinetic exercises

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.

• Study Type: Interventional
• Enrollment (Anticipated): 81
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Reus, Spain, 43201
    • Recruiting
    • Hospital Universitari Sant Joan
    • Contact: Carme Casajuana, PT; Phone Number: 50630 +34 977310300; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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: ST; Standard therapy: The 10 first rehabilitation sessions will be common (manual therapy, electrotherapy, proprioceptive reeducation, isometric exercises, bike exercise and cryotherapy); Other Names: Standard therapy; 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.
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: ST; Standard therapy: The 10 first rehabilitation sessions will be common (manual therapy, electrotherapy, proprioceptive reeducation, isometric exercises, bike exercise and cryotherapy); Other Names: Standard therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee functionality with the Lysholm Test.	Questionnaire with 8 questions that the patient must answer with regard to the functionality of the affected knee. Maximum functionality 100 points.	7 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of pain with the Visual Analogue Scale (VAS).	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.	7 weeks
Metabolomic biomarkers	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.	7 weeks

Collaborators and Investigators

• Sponsor: University Rovira i Virgili
• Collaborators: Hospital Universitari Sant Joan de Reus

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: January 22, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (ESTIMATE): January 24, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 17, 2014
• Last Update Submitted That Met QC Criteria: March 14, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Cost-effectiveness; Physiotherapy; Isokinetics; Partial meniscectomy
• Other Study ID Numbers: MENFIS