Assessment of Different Rehabilitation Treatments After a Partial Removal of the Meniscus

Rehabilitation Post-meniscectomy Clinical Trial

— MENFIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01775345
• Other study ID #: MENFIS
• Status: Recruiting
• Phase: Phase 2
• First received: January 22, 2013
• Last updated: March 14, 2014
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2014
• Source: University Rovira i Virgili
• Contact: Carme Casajuana, PT
• Phone: +34 977310300
• Email: ccasajuana[@]grupsagessa.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rehabilitation Post-meniscectomy

Intervention

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.
• 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.
• 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.
• ST
Standard therapy: The 10 first rehabilitation sessions will be common (manual therapy, electrotherapy, proprioceptive reeducation, isometric exercises, bike exercise and cryotherapy)

Locations

Country	Name	City	State
Spain	Hospital Universitari Sant Joan	Reus

Sponsors (2)

Lead Sponsor	Collaborator
University Rovira i Virgili	Hospital Universitari Sant Joan de Reus

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Primary	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	No
Secondary	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	No