Muscle FatigueMENS_PENCT07877337
Microcurrent Therapy and the Post-Exercise Physiological Response (MENS_PE)
A study testing Microcurrents Therapy in people with Muscle Fatigue, run by University of Castilla-La Mancha.
Trial summary
The goal of this clinical trial is to find out whether microcurrent therapy changes blood levels of creatine kinase, a marker of muscle stress, during the first 48 hours after exercise in military personnel. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Fatigue
- What is being tested?
- Microcurrents Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 10 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age between 18 and 45 years.
- Active-duty military personnel.
- Healthy volunteers with current medical clearance.
- Skin over the quadriceps free of lesions, burns, or irritation.
- Availability and willingness to comply with the proposed intervention protocol.
- Informed consent form read and signed.
Who cannot join
- Implanted electronic devices: pacemakers, defibrillators, neurostimulators, etc.
- Neuromuscular disease or peripheral neuropathy.
- Treatment for HIV or chronic viral infections.
- Uncontrolled seizure disorders (active epilepsy).
- Uncontrolled, clinically significant heart disease.
- Depression.
Show all 19Show fewer
- Uncontrolled hypertension.
- Thrombosis.
- Diabetes with neuropathy or impaired wound healing.
- Active neoplasms or suspected cancer.
- Recent musculoskeletal injuries (within the past three months) or chronic muscle pain in a lower limb.
- Recent major surgery.
- A dermatological condition in the quadriceps region.
- Prescription of medications that may confound pain assessment during the seven days before or during the intervention, including nonsteroidal anti-inflammatory drugs (NSAIDs), muscle relaxants, and systemic corticosteroids.
- Long-term treatment for hypercholesterolemia.
- Prescription of antipsychotic or neuroleptic medications.
- Long-term treatment for hypertriglyceridemia.
- Alcohol or other substance abuse.
- Inability to follow the intervention instructions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Microcurrent Therapy and the Post-Exercise Physiological Response: Effects on Creatine Kinase and Associations With Lactate.
The goal of this clinical trial is to find out whether microcurrent therapy changes blood levels of creatine kinase, a marker of muscle stress, during the first 48 hours after exercise in military personnel.
The main question is: Do creatine kinase levels after exercise differ between people who receive active microcurrent therapy and those who receive a sham treatment?
Read more
Twenty participants will complete a standardized exercise session. Participants will be randomly assigned to one of two groups: 10 will use an active microcurrent device, and 10 will use a sham device for the same period after exercise. The sham device looks and lights up like the active device but delivers no microcurrents.
Researchers will measure creatine kinase before exercise and 24 and 48 hours afterward, then compare how levels change in the two groups. Investigators will also measure blood lactate and perceived effort shortly after exercise, before either device is applied. Participants will report any difficulties using the device, discomfort, effects on sleep or rest, and unwanted effects.
Read the detailed description
Background and study design
Demanding physical exercise can cause physiological changes that persist after the activity has ended. Creatine kinase (CK) is an enzyme whose concentration in the blood can increase following muscle stress. This study will investigate whether prolonged transcutaneous microcurrent therapy after exercise changes the pattern of serum CK concentrations during the first 48 hours of recovery. The study will also characterize the immediate response to exercise and assess the practical use and tolerability of the intervention.
This is a randomized, controlled, parallel-group clinical trial involving 20 participants. Participants will be randomized in a 1:1 ratio to active microcurrent therapy or sham microcurrent therapy, with 10 participants in each group. All participants will complete the same standardized exercise protocol, and both groups will follow the same device application procedure. Participants will apply the devices to both legs for at least seven hours per day on each leg throughout the post-exercise treatment period.
The sham device has been modified so that its indicator light turns on in the same way as the active device, while it delivers no microcurrent output. Participants and outcome assessors will be blinded to group assignment. The personnel responsible for assessing outcomes will not be involved in assigning participants to groups.
Study objectives
Primary objective: To determine the effect of microcurrent therapy on the post-exercise serum creatine kinase response during the first 48 hours of recovery.
Secondary objectives:
Objective 1: To assess the feasibility and tolerability of microcurrent therapy, including difficulties with administration, adverse events, negative effects on sleep or rest.
Objective 2: To characterize the blood lactate response to the standardized exercise protocol and its short-term recovery during the first 30 minutes following exercise.
Objective 3: To characterize the change in perceived exertion immediately after exercise and during the first 30 minutes of recovery.
Objective 4: To assess the success of participant and assessor blinding.
Exploratory objectives:
Exploratory objective 1: To investigate the association between blood lactate concentrations after exercise and CK concentrations at 24 hours and 48 hours
Exploratory objective 2: To examine the relationship between post-exercise lactate concentration and subsequent CK concentration according to treatment allocation.
Exploratory objective 3: To investigate the association between early lactate recovery and early Rating of Perceived Exertion (RPE) recovery.
- Conditions
- Muscle Fatigue
- Being tested
- Microcurrents Therapy, Sham Microcurrent Therapy
- Keywords
- Microcurrent therapy, Transcutaneous microcurrent stimulation, Muscle fatigue, Post-exercise recovery, Creatine kinase, Lactate, Military personnel, Rating of perceived exertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcurrents TherapyDevice
Prolonged post-exercise transcutaneous microcurrent therapy using an active microcurrent patch applied for minium 7 hours following exercise to promote recovery from exercise-induced muscle fatigue.
Sham Microcurrent TherapyDevice
Prolonged post-exercise sham transcutaneous microcurrent intervention using a modified device engineered to reproduce the appearance and operating indicators of the active device, including illumination of the indicator light, while delivering no microcurrent output. The sham device is applied following the same procedure and for the same duration as the active intervention.
| Study group | Role | What they receive |
|---|---|---|
| Active Microcurrent Therapy | Active comparator | Participants randomized to the active microcurrent group will complete the standardized exercise protocol and the immediate and 30-minute post-exercise assessments before beginning treatment. Participants will then apply active transcutaneous microcurrent devices to both legs. Each leg will receive at least seven hours of device application per day throughout the post-exercise treatment period. The devices will deliver microcurrent output while in use. The study team will record any difficulties with application, adverse events, effects on sleep or rest, and perceived unpleasantness. Receives: Device: Microcurrents Therapy |
| Sham Microcurrent Therapy | Sham comparator | Participants randomized to the sham microcurrent group will complete the standardized exercise protocol and the immediate and 30-minute post-exercise assessments before beginning treatment. The participants will then apply sham devices to both legs. Each leg will receive at least seven hours of device application per day throughout the post-exercise treatment period.
The sham device is the same model as the active device, but it has been modified by an engineer. Its indicator light illuminates in the same way as the active device, while the microcurrent-generating function remains inactive and no microcurrent is delivered. The devices will otherwise be applied in exactly the same way in both groups, preserving participant and outcome-assessor blinding.
The study team will record any difficulties with application, adverse events, effects on sleep or rest, and perceived unpleasantness. Receives: Device: Sham Microcurrent Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatine kinase (CK) concentration.
Unit: U/L.
Definition: Serum CK concentration will be measured at baseline and during the post- exercise recovery period at 24 and 48 hours. Baseline CK will be calculated as the mean of two measurements obtained one day before and on the day of the exercise protocol.
The primary analysis will evaluate whether the CK concentrations over time differs between the active microcurrent and sham groups.
Measured: Baseline, 24 hours, and 48 hours after exercise.
Secondary outcomes (7)
Participant-perceived feasibility of microcurrent treatment administration
Participants will report whether the intervention was easy to administer using a dichotomous response (Yes/No). The outcome will be summarized as the number and percentage of participants answering "Yes".
Measured: Immediately after the microcurrent treatment period.
Blood lactate concentration
Unit: mmol/L.
Definition: blood lactate concentration will be measured at baseline and inmediately post- exercise and at 30 min post-exercise.
The analysis will focus on changes over time during the first 30 minutes of recovery. The primary comparisons will concern the effect of time rather than the effect of treatment group, because all lactate measurements are obtained before microcurrent treatment. These measurements will be considered indicators of biochemical response to the exercise bout rather than measures of the effect of microcurrent therapy.
Measured: Pre-exercise, immediately post-exercise, and 30 minutes post-exercise.
Change in perceived exertion after exercise
Unit of Measure: Scale points from 0 to 10 Points
Description: Rating of perceived exertion will be assessed using the Borg Category-Ratio 10 Scale immediately after the standardized exercise protocol and 30 minutes later. The recorded score ranges from a minimum of 0 ("nothing at all") to a maximum of 10 ("extremely strong-maximal exertion"). Higher scores indicate greater perceived exertion, representing a less favorable outcome in terms of perceived exertion.
The change in perceived exertion will be calculated as the score at 30 minutes post-exercise minus the score immediately post-exercise. Possible change scores range from -10 to +10. Negative values indicate a reduction in perceived exertion, representing more favorable perceptual recovery; positive values indicate an increase, representing less favorable perceptual recovery.
Measured: Immediately post-exercise and 30 minutes post-exercise.
Participant and assessor blinding success
Unit: Categorical responses
Blinding success will be assessed by asking participants and outcome assessors to identify treatment allocation using five predefined response options: (1) strongly believe the treatment was active; (2) somewhat believe the treatment was active; (3) strongly believe the treatment was sham; (4) somewhat believe the treatment was sham; and (5) do not know
Measured: Immediately after completion of the study intervention.
Occurrence of adverse events
The occurrence of adverse events will be recorded as a yes/no response for each participant. The outcome will be reported as the number of participants experiencing at least one adverse event. The nature and characteristics of reported adverse events will also be documented descriptively.
Measured: Immediately after the microcurrent treatment period.
Negative effects on sleep or rest
Negative effects on sleep or rest during the microcurrent intervention will be assessed using participant-reported yes/no responses. The outcome will be reported as the number of participants reporting at least one negative effect on sleep or rest. The nature of reported effects will also be documented descriptively.
Measured: During and Immediately after the microcurrent treatment period.
Perceived unpleasantness of the microcurrent intervention
Unit of Measure: Numerical Rating Scale (NRS) score (1-10).
Description: Perceived unpleasantness of the microcurrent intervention will be assessed using a 11-point Numerical Rating Scale (NRS), ranging from 0 ("not unpleasant at all") to 10 ("extremely unpleasant"). Higher scores indicate greater perceived unpleasantness
Measured: Immediately after the microcurrent treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle FatigueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, parallel-group clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Avendaño-Coy, PhD, Principal investigator, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877337
- Sponsor's protocol ID
- MENS_Post-Exercise
- Acronym
- MENS_PE
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is planned to make the anonymized datasets publicly available through the Zenodo repository.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcurrent Therapy and the Post-Exercise Physiological Response: Effects on Creatine Kinase and Associations With Lactate.
- ClinicalTrials.gov ID
- NCT07877337
- Acronym / sponsor ID
- MENS_PE / MENS_Post-Exercise
- Conditions
- Muscle Fatigue
- Keywords
- Microcurrent therapy, Transcutaneous microcurrent stimulation, Muscle fatigue, Post-exercise recovery, Creatine kinase, Lactate, Military personnel, Rating of perceived exertion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 16 Oct 2026 (actual)
- 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.
The goal of this clinical trial is to find out whether microcurrent therapy changes blood levels of creatine kinase, a marker of muscle stress, during the first 48 hours after exercise in military personnel.
The main question is: Do creatine kinase levels after exercise differ between people who receive active microcurrent therapy and those who receive a sham treatment?
Twenty participants will complete a standardized exercise session. Participants will be randomly assigned to one of two groups: 10 will use an active microcurrent device, and 10 will use a sham device for the same period after exercise. The sham device looks and lights up like the active device but delivers no microcurrents.
Researchers will measure creatine kinase before exercise and 24 and 48 hours afterward, then compare how levels change in the two groups. Investigators will also measure blood lactate and perceived effort shortly after exercise, before either device is applied. Participants will report any difficulties using the device, discomfort, effects on sleep or rest, and unwanted effects.
Detailed description
Background and study design
Demanding physical exercise can cause physiological changes that persist after the activity has ended. Creatine kinase (CK) is an enzyme whose concentration in the blood can increase following muscle stress. This study will investigate whether prolonged transcutaneous microcurrent therapy after exercise changes the pattern of serum CK concentrations during the first 48 hours of recovery. The study will also characterize the immediate response to exercise and assess the practical use and tolerability of the intervention.
This is a randomized, controlled, parallel-group clinical trial involving 20 participants. Participants will be randomized in a 1:1 ratio to active microcurrent therapy or sham microcurrent therapy, with 10 participants in each group. All participants will complete the same standardized exercise protocol, and both groups will follow the same device application procedure. Participants will apply the devices to both legs for at least seven hours per day on each leg throughout the post-exercise treatment period.
The sham device has been modified so that its indicator light turns on in the same way as the active device, while it delivers no microcurrent output. Participants and outcome assessors will be blinded to group assignment. The personnel responsible for assessing outcomes will not be involved in assigning participants to groups.
Study objectives
Primary objective: To determine the effect of microcurrent therapy on the post-exercise serum creatine kinase response during the first 48 hours of recovery.
Secondary objectives:
Objective 1: To assess the feasibility and tolerability of microcurrent therapy, including difficulties with administration, adverse events, negative effects on sleep or rest.
Objective 2: To characterize the blood lactate response to the standardized exercise protocol and its short-term recovery during the first 30 minutes following exercise.
Objective 3: To characterize the change in perceived exertion immediately after exercise and during the first 30 minutes of recovery.
Objective 4: To assess the success of participant and assessor blinding.
Exploratory objectives:
Exploratory objective 1: To investigate the association between blood lactate concentrations after exercise and CK concentrations at 24 hours and 48 hours
Exploratory objective 2: To examine the relationship between post-exercise lactate concentration and subsequent CK concentration according to treatment allocation.
Exploratory objective 3: To investigate the association between early lactate recovery and early Rating of Perceived Exertion (RPE) recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, parallel-group clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Active Microcurrent Therapy | Active comparator | Device: Microcurrents TherapyParticipants randomized to the active microcurrent group will complete the standardized exercise protocol and the immediate and 30-minute post-exercise assessments before beginning treatment. Participants will then apply active transcutaneous microcurrent devices to both legs. Each leg will receive at least seven hours of device application per day throughout the post-exercise treatment period. The devices will deliver microcurrent output while in use. The study team will record any difficulties with application, adverse events, effects on sleep or rest, and perceived unpleasantness. |
| Sham Microcurrent Therapy | Sham comparator | Device: Sham Microcurrent TherapyParticipants randomized to the sham microcurrent group will complete the standardized exercise protocol and the immediate and 30-minute post-exercise assessments before beginning treatment. The participants will then apply sham devices to both legs. Each leg will receive at least seven hours of device application per day throughout the post-exercise treatment period. The sham device is the same model as the active device, but it has been modified by an engineer. Its indicator light illuminates in the same way as the active device, while the microcurrent-generating function remains inactive and no microcurrent is delivered. The devices will otherwise be applied in exactly the same way in both groups, preserving participant and outcome-assessor blinding. The study team will record any difficulties with application, adverse events, effects on sleep or rest, and perceived unpleasantness. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 45 years.
- Active-duty military personnel.
- Healthy volunteers with current medical clearance.
- Skin over the quadriceps free of lesions, burns, or irritation.
- Availability and willingness to comply with the proposed intervention protocol.
Key exclusion criteria (19 listed)
- Implanted electronic devices: pacemakers, defibrillators, neurostimulators, etc.
- Neuromuscular disease or peripheral neuropathy.
- Treatment for HIV or chronic viral infections.
- Uncontrolled seizure disorders (active epilepsy).
- Uncontrolled, clinically significant heart disease.
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 |
|---|---|---|
| Microcurrents TherapyProlonged post-exercise transcutaneous microcurrent therapy using an active microcurrent patch applied for minium 7 hours following exercise to promote recovery from exercise-induced muscle fatigue. | Device | Active Microcurrent Therapy |
| Sham Microcurrent TherapyProlonged post-exercise sham transcutaneous microcurrent intervention using a modified device engineered to reproduce the appearance and operating indicators of the active device, including illumination of the indicator light, while delivering no microcurrent output. The sham device is applied following the same procedure and for the same duration as the active intervention. | Device | Sham Microcurrent Therapy |
Primary outcome
Serum creatine kinase (CK) concentration.
Time frame: Baseline, 24 hours, and 48 hours after exercise.
Unit: U/L. Definition: Serum CK concentration will be measured at baseline and during the post- exercise recovery period at 24 and 48 hours. Baseline CK will be calculated as the mean of two measurements obtained one day before and on the day of the exercise protocol. The primary analysis will evaluate whether the CK concentrations over time differs between the active microcurrent and sham groups.
7 secondary outcomes
Participant-perceived feasibility of microcurrent treatment administration
Time frame: Immediately after the microcurrent treatment period.
Blood lactate concentration
Time frame: Pre-exercise, immediately post-exercise, and 30 minutes post-exercise.
Change in perceived exertion after exercise
Time frame: Immediately post-exercise and 30 minutes post-exercise.
Participant and assessor blinding success
Time frame: Immediately after completion of the study intervention.
Occurrence of adverse events
Time frame: Immediately after the microcurrent treatment period.
Negative effects on sleep or rest
Time frame: During and Immediately after the microcurrent treatment period.
Perceived unpleasantness of the microcurrent intervention
Time frame: Immediately after the microcurrent treatment period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. It is planned to make the anonymized datasets publicly available through the Zenodo repository.
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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.
Juan Avendaño-Coy, PhD principal investigator
University of Castilla-La Mancha
Questions about this trial
What is this clinical trial studying?
A study testing Microcurrents Therapy in people with Muscle Fatigue, run by University of Castilla-La Mancha.
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 6 inclusion and 19 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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Avendaño-Coy, PhD (+34 926051649, Juan.Avendano@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum creatine kinase (CK) concentration. (time frame: Baseline, 24 hours, and 48 hours after exercise.). 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 16 Oct 2026.