Delayed Onset Muscle SorenessNCT02322489
Efficacy of Microcurrent Therapy After Eccentric Exercise
A study testing Microcurrent Therapy in people with Delayed Onset Muscle Soreness, run by University of Liege at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Delayed Onset Muscle Soreness
- What is being tested?
- Microcurrent Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2015to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Asymptomatic subjects
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Delayed Onset Muscle Soreness
- Being tested
- Microcurrent Therapy, Sham microcurrent therapy
- Keywords
- microcurent, pain, flexibility
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcurrent TherapyDevice
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 therapyDevice
Several electrodes are placed over the muscles involved in the provocative task. The microcurrent therapy is then started but lasts only for five seconds.
| Study group | Role | What they receive |
|---|---|---|
| Sham microcurrent therapy | Sham comparator | 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. Receives: Device: Sham microcurrent therapy |
| Microcurrent Group | Experimental | 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. Receives: Device: Microcurrent Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain (Visual analogue scale)
Measured: baseline, post-provocative task, post-treatment, 48h follow-up, following days until pain disappears
Secondary outcomes (4)
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
Measured: baseline, post-provocative task, post-treatment, 48h follow-up
Functional test (Unilateral counter-movement jump)
Unilateral counter-movement jump
Measured: baseline, post-provocative task, post-treatment, 48h follow-up
Pain sensibility threshold (Determined by using a dolorimeter)
Determined by using a dolorimeter
Measured: baseline, post-provocative task, post-treatment, 48h follow-up
Isometric strength (Maximal voluntary contraction of knee flexor and extensor muscles)
Maximal voluntary contraction of knee flexor and extensor muscles
Measured: baseline, post-provocative task, post-treatment, 48h follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Onset Muscle SorenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christophe Demoulin, University of Liege
- Investigators
- Christophe Demoulin, PhD, Principal investigator, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322489
- Sponsor's protocol ID
- Microcurrent
- Status last verified
- Jun 2015
- First submitted
- 6 Dec 2014
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Microcurrent Therapy After Eccentric Exercise
- ClinicalTrials.gov ID
- NCT02322489
- Acronym / sponsor ID
- Microcurrent
- Conditions
- Delayed Onset Muscle Soreness
- Keywords
- microcurent, pain, flexibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham microcurrent therapy | Sham comparator | Device: Sham microcurrent therapyThe 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. |
| Microcurrent Group | Experimental | Device: Microcurrent TherapyThe 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Asymptomatic subjects
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microcurrent TherapySeveral electrodes are placed over the muscles involved in the provocative task. The microcurrent therapy is then started and lasts for one hour. | Device | Microcurrent Group |
| Sham microcurrent therapySeveral electrodes are placed over the muscles involved in the provocative task. The microcurrent therapy is then started but lasts only for five seconds. | Device | Sham microcurrent therapy |
Primary outcome
Intensity of pain (Visual analogue scale)
Time frame: baseline, post-provocative task, post-treatment, 48h follow-up, following days until pain disappears
4 secondary outcomes
Flexibility of quadriceps and hamstrings muscles
Time frame: 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
Pain sensibility threshold (Determined by using a dolorimeter)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Demoulin, PhD principal investigator
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microcurrent Therapy in people with Delayed Onset Muscle Soreness, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of pain (Visual analogue scale) (time frame: baseline, post-provocative task, post-treatment, 48h follow-up, following days until pain disappears). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.