- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02322489
Efficacy of Microcurrent Therapy After Eccentric Exercise
15 participants will be included in the present study. They will attend two groups of three sessions (i.e. sessions 1-2-3 and sessions 4-5-6) spaced by 3 months:
- session 1 and 4 (performed a few days before the experimental session): session for participants to get familiarized with the test battery.
- session 2 and 5: experimental session (the test battery followed by the provocative task, the test battery, the one-hour "treatment" and the test battery again).
- session 3 and 6 (performed 2 days later): the test battery.
The test battery included flexibility, functional, pressure pain threshold tests.
The provocative task was an isokinetic eccentric task for knee flexors and extensors.
The treatment was either a microcurrent therapy or a placebo microcurrent therapy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective:
To study the efficacy of microcurrent to reduce DOMS (Delayed Onset Muscle Soreness) occuring after an eccentric exercise
Methods:
Experimental protocol
Participants will attend two groups of three sessions (i.e. sessions 1-2-3 and sessions 4-5-6) spaced by 3 months:
- session 1 and 4 (performed a few days before the experimental session): session for participants to get familiarized with the test battery.
- session 2 and 5: experimental session: the test battery followed by the provocative task, the test battery, the one-hour "treatment" (real microcurrents at one of the session and placebo microcurrents at the other one) and the test battery again.
- session 3 and 6 (performed 2 days later): the test battery.
Before starting session 2, patients will be randomized into the microcurrent group or the placebo microcurrent group. Three months later, participants will change of group.
The Test Battery: it will be conducted by a blind (to the treatment) investigator. It will include knee flexor and extensor flexibility tests, a functional test (unilateral " counter-movement jump "), a pain to measure pain threshold of thigh muscles and an isometric maximal voluntary contraction (MVC) test of knee flexors and extensors.
The Provocative task: 40 isokinetic eccentric contractions of knee flexors and extensors.
The one-hour Treatment: with the participant lying on an examination table, several electrodes were located over the muscles involved in the provocative task. The microcurrent therapy was then started. It was stopped after 5 seconds in the "Placebo group" and after one hour in the real "Microcurrent group". The microcurrents were delivered by the machine B-E-St®.
Follow-up: in addition to the 48hours follow-up (session 3/6), participants will fill in a pain visual analogue scale each day after the session 2/5.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Liege, Belgium, 4000
- Liege University Hospital Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Asymptomatic subjects
Exclusion Criteria:
- practice of sports >3h per week
- present pain in the lower limbs
- history of thigh muscle injuries
- recent injury (last 3 months) of the lower limbs
- recent (last 3 months) plyometric exercises or lower limbs strengthening program.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Sham microcurrent therapy
The participant is lying on an examination table for one hour; several electrodes are placed over the muscles involved in the provocative task.
The microcurrent therapy is then started but it lasts only for 5 seconds.
|
Several electrodes are placed over the muscles involved in the provocative task.
The microcurrent therapy is then started but lasts only for five seconds.
|
Experimental: Microcurrent Group
The participant is lying on an examination table for one hour; several electrodes are placed over the muscles involved in the provocative task.
The microcurrent therapy is then started.
|
Several electrodes are placed over the muscles involved in the provocative task.
The microcurrent therapy is then started and lasts for one hour.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intensity of pain (Visual analogue scale)
Time Frame: baseline, post-provocative task, post-treatment, 48h follow-up, following days until pain disappears
|
baseline, post-provocative task, post-treatment, 48h follow-up, following days until pain disappears
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Flexibility of quadriceps and hamstrings muscles
Time Frame: baseline, post-provocative task, post-treatment, 48h follow-up
|
Flexibility of quadriceps muscle was assessed by means of the Prone Quadriceps Flexibility test. Flexibility of hamstrings was assessed by means of the Straight Leg Raising (SLR) test |
baseline, post-provocative task, post-treatment, 48h follow-up
|
Functional test (Unilateral counter-movement jump)
Time Frame: baseline, post-provocative task, post-treatment, 48h follow-up
|
Unilateral counter-movement jump
|
baseline, post-provocative task, post-treatment, 48h follow-up
|
Pain sensibility threshold (Determined by using a dolorimeter)
Time Frame: baseline, post-provocative task, post-treatment, 48h follow-up
|
Determined by using a dolorimeter
|
baseline, post-provocative task, post-treatment, 48h follow-up
|
Isometric strength (Maximal voluntary contraction of knee flexor and extensor muscles)
Time Frame: baseline, post-provocative task, post-treatment, 48h follow-up
|
Maximal voluntary contraction of knee flexor and extensor muscles
|
baseline, post-provocative task, post-treatment, 48h follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christophe Demoulin, PhD, University of Liège
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Microcurrent
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