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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02322489
Other study ID # Microcurrent
Secondary ID
Status Completed
Phase N/A
First received December 6, 2014
Last updated June 8, 2015
Start date January 2015
Est. completion date June 2015

Study information

Verified date June 2015
Source University Hospital of Liege
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date June 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 25 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
Microcurrent Therapy
Several electrodes are placed over the muscles involved in the provocative task. The microcurrent therapy is then started and lasts for one hour.
Sham microcurrent therapy
Several electrodes are placed over the muscles involved in the provocative task. The microcurrent therapy is then started but lasts only for five seconds.

Locations

Country Name City State
Belgium Liege University Hospital Center Liege

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intensity of pain (Visual analogue scale) baseline, post-provocative task, post-treatment, 48h follow-up, following days until pain disappears No
Secondary Flexibility of quadriceps and hamstrings muscles 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 No
Secondary Functional test (Unilateral counter-movement jump) Unilateral counter-movement jump baseline, post-provocative task, post-treatment, 48h follow-up No
Secondary Pain sensibility threshold (Determined by using a dolorimeter) Determined by using a dolorimeter baseline, post-provocative task, post-treatment, 48h follow-up No
Secondary Isometric strength (Maximal voluntary contraction of knee flexor and extensor muscles) Maximal voluntary contraction of knee flexor and extensor muscles baseline, post-provocative task, post-treatment, 48h follow-up No
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