Recovery, PsychologicalNCT06855316
Evaluating Combined Electromagnetic Stimulation for Enhanced Physical and Psychological Recovery in Athletes with DOMS
A study testing electromagnetic stimulation in people with Recovery, Psychological and Transcranial Magnetic Stimulation, run by Sierra Varona SL at 1 site in Spain.
Trial summary
This randomized controlled trial explores the impact of a combined transcranial and peripheral electromagnetic stimulation over the potential correlation between psychological well-being and recovery outcomes of young athletes experiencing Delayed Onset Muscle Soreness. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Recovery, Psychological, Transcranial Magnetic Stimulation
- What is being tested?
- electromagnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 24 Feb 2025to 7 Mar 2025
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- be male,
- aged between 18 and 35 years
- engage in regular exercise at least three times per week for a minimum of one year
- have no hypersensitivity to the areas designated for peripheral stimulation
- be free from chronic conditions incompatible with exercise performance
- have no recent musculoskeletal injuries to the lower limbs within the past six months,
- be non-smokers
- possess the cognitive capacity to understand the study's objectives and procedures.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Alberto Sanchez Sierra
Toledo, TOLEDO, 45007
ALBERTO SANCHEZ SIERRA, 608801238, alberto.sanchez@uclm.es
About this study
Official title: Evaluating Combined Electromagnetic Stimulation for Enhanced Physical and Psychological Recovery in Athletes with DOMS: a Randomized Controlled Study
This randomized controlled trial explores the impact of a combined transcranial and peripheral electromagnetic stimulation over the potential correlation between psychological well-being and recovery outcomes of young athletes experiencing Delayed Onset Muscle Soreness.
Read the detailed description
This randomized controlled trial explores the impact of a combined transcranial and peripheral electromagnetic stimulation (TMS and PES) over the potential correlation between psychological well-being and recovery outcomes of young athletes experiencing Delayed Onset Muscle Soreness. Grounded in the emerging theory of DOMS as an axonopathy affecting muscle spindles, this study examines whether paired-associative stimulation can show link over physical and psychological recovery processes. Forty-eight male athletes, aged 18 to 35 years, regularly engaged in exercise, will be randomly assigned to one of four groups: Control (placebo), PES, TMS, and Combined Stimulation (TMS + PES). All participants will perform a muscle-damaging exercise protocol to induce DOMS, followed by the assigned electromagnetic intervention. Assessments will include dynamometry, Counter Movement Jump (CMJ), Visual Analog Scale for Fatigue (VAS-F), Pain Pressure Threshold (PPT), sprint performance, and various psychological measures, such as the State-Trait Anxiety Inventory (STAI), Acceptance and Action Questionnaire-II (AAQ-II), and the Spanish versions of the Big Five Personality Traits, Perceived Stress Scale (PSS), and the Zung Self-Rating Depression Scale. These assessments will be conducted at baseline and at multiple intervals post-exercise (1 hour, 24 hours, 48 hours, and 72 hours).
- Being tested
- electromagnetic stimulation
- Keywords
- transcraneal magnetic stimulation, delay onset muscle soreness, psychological profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electromagnetic stimulationDevice
After performing a high-intensity eccentric exercise session, participants will undergo a daily session of transcranial and/or peripheral magnetic stimulation for three days. The objective is to enhance nerve conduction, which, according to the latest theories on DOMS, may be the cause of decreased athletic performance
| Study group | Role | What they receive |
|---|---|---|
| control/placebo group | Placebo comparator | Participants will be treated using the same device used in active stimulation groups, but the device will be turned off, thus providing a placebo effect. To maintain the placebo integrity, a pre-recorded sound mimicking the active device will be played during the session. Additionally, participants in the transcranial component will wear the machine's flap, similar to the TMS application, to further simulate the experience of active treatment. This method will ensure that the placebo control will be robust, allowing for accurate comparison with active treatments. Receives: Device: electromagnetic stimulation |
| Super Inductive (P) Group | Experimental | Participants in the Super Inductive (P) group will receivePeripheral Electromagnetic Stimulation (PES) following a Long-Term Potentiation (LTP) protocol. This protocol involved five cycles of stimulation at a frequency of 100 Hz, each lasting for 5 seconds, with a rest interval of 55 seconds between cycles. The total duration of the PES treatment will be approximately 10 minutes, as suggested by Lang et al. (2007) and Milanović et al. (2011) (Lang et al., 2007; Milanović et al., 2011). This stimulation aimes to enhance peripheral nerve activation and support recovery through localized neuromodulation. Receives: Device: electromagnetic stimulation |
| Transcranial (T) Group | Experimental | Participants in the Transcranial (T) group will get Transcranial Magnetic Stimulation (TMS) targeting at the primary motor cortex (M1). The protocol will be based on the findings of Dietmann et al. (2023) and Todd et al. (2003), consisting of the delivery of 2000 pulses of TMS over a minimum duration of 20 minutes (Dietmann et al., 2023; Todd et al., 2003). This intervention aimes to modulate cortical excitability, potentially enhancing muscle recovery through central nervous system adaptation. Receives: Device: electromagnetic stimulation |
| Combined Stimulation (Comb) Group | Experimental | Participants in the Combined (Comb) group will receive both TMS and PES simultaneously, providing a synergistic intervention aimed at optimizing recovery outcomes. The combined stimulation session will last 30 minutes, integrating the benefits of both central and peripheral modulation. This dual approach targets the M1 region for central effects while also stimulating peripheral nerves to promote localized recovery processes. Receives: Device: electromagnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Big Five Personality Trait Short Questionnaire (Spanish version)
This tool is used to evaluate five core personality dimensions: neuroticism, extraversion, openness, agreeableness, and conscientiousness (Airagnes et al., 2021). The abbreviated version contains 10 items rated on a 5-point Likert scale, where 1 indicates "completely disagree" and 5 represents "completely agree." An example item from this questionnaire is, "I see myself as a person who gets nervous easily." This measure provided insight into the stable personality characteristics of the athletes and their potential impact on recovery and pain perception.Each item is rated on a Likert scale, typically ranging from 1 (Strongly Disagree) to 5 (Strongly Agree).
Scores for each trait are summed up separately, with higher scores indicating stronger presence of that personality trait.
Measured: Participants will complete questionnaires at 2 time points: just before treatment and after de last treatment (3 days after the first time frame).
State-Trait Anxiety Inventory (STAI, Spanish version)
To assess anxiety levels, the STAI will be used. Participants rated their responses on a 4-point Likert scale, where 1 means "not at all" and 4 means "very much," reflecting their state and trait anxiety. This measure allowed for an analysis of how anxiety levels might correlate with recovery outcomes and subjective pain experiences. It consists of 40 items, divided into two subscales:
STAI-S (State Anxiety, 20 items): Assesses temporary feelings of anxiety in a specific moment.
STAI-T (Trait Anxiety, 20 items): Measures a person's general tendency to experience anxiety over time.
Each item is rated on a 4-point Likert scale:
STAI-S: 1 (Not at all) to 4 (Very much so) STAI-T: 1 (Almost never) to 4 (Almost always) Scores range from 20 to 80 for each subscale, with higher scores indicating greater anxiety levels. The STAI is widely used in both clinical and research settings to assess anxiety in different populations.
Measured: Participants will complete questionnaires at 2 time points: just before treatment and after de last treatment (3 days after the first time frame)
Acceptance and Action Questionnaire-II (AAQ-II, Spanish version)
The AAQ-II measures psychological inflexibility and experiential avoidance, which are critical in understanding how individuals cope with discomfort and stress (Carreira-Míguez et al., 2022). The 7-item questionnaire uses a 7-point Likert scale (0 = "never true" to 7 = "always true"), with higher scores indicating greater levels of psychological distress.The total score ranges from 7 to 49, with higher scores indicating greater experiential avoidance and psychological inflexibility, while lower scores reflect higher psychological flexibility. This scale is commonly used in clinical and research settings to evaluate mental health and intervention outcomes.
Measured: Participants will complete questionnaires at 2 time points: just before treatment and after de last treatment (3 days after the first time frame)
UCLA Loneliness Scale (Spanish version):
The Spanish version of the Three-Item Loneliness Scale will be administered to assess perceived social isolation. Participants rated each of the three items on a 3-point scale, with 1 meaning "never" and 3 meaning "frequently." This scale helped to explore the role of social support and perceived isolation in recovery from physical exertion.The scale consists of 20 items, each rated on a 4-point Likert scale:
- (Never)
- (Rarely)
- (Sometimes)
- (Often) The total score ranges from 20 to 80, with higher scores indicating greater levels of loneliness. There is no strict cutoff, but higher scores generally reflect more significant perceived loneliness.
Measured: Participants will complete questionnaires at 2 time points: just before treatment and after de last treatment (3 days after the first time frame)
Zung Self-Rating Depression Scale (Spanish version):
This self-applied scale contains 20 items designed to assess the severity of depressive symptoms, with both positive and negative formulations. The Zung scale's high specificity (over 80%) makes it a reliable tool for evaluating depression levels in the study's population (Carreira-Míguez et al., 2022). These baseline psychological assessments enabled the researchers to correlate psychological variables with recovery markers throughout the study.t consists of 20 questions, each evaluating various aspects of depression, including mood, physical symptoms, and psychomotor activity.
Scoring
Each question is rated on a 4-point Likert scale:
- (A little of the time)
- (Some of the time)
- (Good part of the time)
- (Most of the time)
The total score ranges from 20 to 80, with higher scores indicating more severe depression:
20-44: Normal range 45-59: Mild depression 60-69: Moderate to marked depression 70-80: Severe depression
Measured: Participants will complete questionnaires at 2 time points: just before treatment and after de last treatment (3 days after the first time frame)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start24 Feb 2025 (estimated)
- Primary completion3 Mar 2025 (estimated)
- Study completion7 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recovery, PsychologicalStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sierra Varona SL
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Europea de Madrid
- Responsible party
- Principal investigator, Alberto Sánchez Sierra, Sierra Varona SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855316
- Sponsor's protocol ID
- 017
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Combined Electromagnetic Stimulation for Enhanced Physical and Psychological Recovery in Athletes with DOMS: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06855316
- Acronym / sponsor ID
- 017
- Keywords
- transcraneal magnetic stimulation, delay onset muscle soreness, psychological profile
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sierra Varona SLUniversity, hospital or other
- Collaborators
- Universidad Europea de Madrid
- Study start
- 24 Feb 2025 (estimated)
- Primary completion
- 3 Mar 2025 (estimated)
- Study completion
- 7 Mar 2025 (estimated)
- First posted
- 3 Mar 2025 (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.
This randomized controlled trial explores the impact of a combined transcranial and peripheral electromagnetic stimulation over the potential correlation between psychological well-being and recovery outcomes of young athletes experiencing Delayed Onset Muscle Soreness.
Detailed description
This randomized controlled trial explores the impact of a combined transcranial and peripheral electromagnetic stimulation (TMS and PES) over the potential correlation between psychological well-being and recovery outcomes of young athletes experiencing Delayed Onset Muscle Soreness. Grounded in the emerging theory of DOMS as an axonopathy affecting muscle spindles, this study examines whether paired-associative stimulation can show link over physical and psychological recovery processes. Forty-eight male athletes, aged 18 to 35 years, regularly engaged in exercise, will be randomly assigned to one of four groups: Control (placebo), PES, TMS, and Combined Stimulation (TMS + PES). All participants will perform a muscle-damaging exercise protocol to induce DOMS, followed by the assigned electromagnetic intervention. Assessments will include dynamometry, Counter Movement Jump (CMJ), Visual Analog Scale for Fatigue (VAS-F), Pain Pressure Threshold (PPT), sprint performance, and various psychological measures, such as the State-Trait Anxiety Inventory (STAI), Acceptance and Action Questionnaire-II (AAQ-II), and the Spanish versions of the Big Five Personality Traits, Perceived Stress Scale (PSS), and the Zung Self-Rating Depression Scale. These assessments will be conducted at baseline and at multiple intervals post-exercise (1 hour, 24 hours, 48 hours, and 72 hours).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control/placebo group | Placebo comparator | Device: electromagnetic stimulationParticipants will be treated using the same device used in active stimulation groups, but the device will be turned off, thus providing a placebo effect. To maintain the placebo integrity, a pre-recorded sound mimicking the active device will be played during the session. Additionally, participants in the transcranial component will wear the machine's flap, similar to the TMS application, to further simulate the experience of active treatment. This method will ensure that the placebo control will be robust, allowing for accurate comparison with active treatments. |
| Super Inductive (P) Group | Experimental | Device: electromagnetic stimulationParticipants in the Super Inductive (P) group will receivePeripheral Electromagnetic Stimulation (PES) following a Long-Term Potentiation (LTP) protocol. This protocol involved five cycles of stimulation at a frequency of 100 Hz, each lasting for 5 seconds, with a rest interval of 55 seconds between cycles. The total duration of the PES treatment will be approximately 10 minutes, as suggested by Lang et al. (2007) and Milanović et al. (2011) (Lang et al., 2007; Milanović et al., 2011). This stimulation aimes to enhance peripheral nerve activation and support recovery through localized neuromodulation. |
| Transcranial (T) Group | Experimental | Device: electromagnetic stimulationParticipants in the Transcranial (T) group will get Transcranial Magnetic Stimulation (TMS) targeting at the primary motor cortex (M1). The protocol will be based on the findings of Dietmann et al. (2023) and Todd et al. (2003), consisting of the delivery of 2000 pulses of TMS over a minimum duration of 20 minutes (Dietmann et al., 2023; Todd et al., 2003). This intervention aimes to modulate cortical excitability, potentially enhancing muscle recovery through central nervous system adaptation. |
| Combined Stimulation (Comb) Group | Experimental | Device: electromagnetic stimulationParticipants in the Combined (Comb) group will receive both TMS and PES simultaneously, providing a synergistic intervention aimed at optimizing recovery outcomes. The combined stimulation session will last 30 minutes, integrating the benefits of both central and peripheral modulation. This dual approach targets the M1 region for central effects while also stimulating peripheral nerves to promote localized recovery processes. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- be male,
- aged between 18 and 35 years
- engage in regular exercise at least three times per week for a minimum of one year
- have no hypersensitivity to the areas designated for peripheral stimulation
- be free from chronic conditions incompatible with exercise performance
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| electromagnetic stimulationAfter performing a high-intensity eccentric exercise session, participants will undergo a daily session of transcranial and/or peripheral magnetic stimulation for three days. The objective is to enhance nerve conduction, which, according to the latest theories on DOMS, may be the cause of decreased athletic performance | Device | Combined Stimulation (Comb) Group, Super Inductive (P) Group, Transcranial (T) Group, control/placebo group |
Primary outcome
Big Five Personality Trait Short Questionnaire (Spanish version)
Time frame: Participants will complete questionnaires at 2 time points: just before treatment and after de last treatment (3 days after the first time frame).
This tool is used to evaluate five core personality dimensions: neuroticism, extraversion, openness, agreeableness, and conscientiousness (Airagnes et al., 2021). The abbreviated version contains 10 items rated on a 5-point Likert scale, where 1 indicates "completely disagree" and 5 represents "completely agree." An example item from this questionnaire is, "I see myself as a person who gets nervous easily." This measure provided insight into the stable personality characteristics of the athletes and their potential impact on recovery and pain perception.Each item is rated on a Likert scale, typically ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Scores for each trait are summed up separately, with higher scores indicating stronger presence of that personality trait.
State-Trait Anxiety Inventory (STAI, Spanish version)
Time frame: Participants will complete questionnaires at 2 time points: just before treatment and after de last treatment (3 days after the first time frame)
To assess anxiety levels, the STAI will be used. Participants rated their responses on a 4-point Likert scale, where 1 means "not at all" and 4 means "very much," reflecting their state and trait anxiety. This measure allowed for an analysis of how anxiety levels might correlate with recovery outcomes and subjective pain experiences. It consists of 40 items, divided into two subscales: STAI-S (State Anxiety, 20 items): Assesses temporary feelings of anxiety in a specific moment. STAI-T (Trait Anxiety, 20 items): Measures a person's general tendency to experience anxiety over time. Each item is rated on a 4-point Likert scale: STAI-S: 1 (Not at all) to 4 (Very much so) STAI-T: 1 (Almost never) to 4 (Almost always) Scores range from 20 to 80 for each subscale, with higher scores indicating greater anxiety levels. The STAI is widely used in both clinical and research settings to assess anxiety in different populations.
Acceptance and Action Questionnaire-II (AAQ-II, Spanish version)
Time frame: Participants will complete questionnaires at 2 time points: just before treatment and after de last treatment (3 days after the first time frame)
The AAQ-II measures psychological inflexibility and experiential avoidance, which are critical in understanding how individuals cope with discomfort and stress (Carreira-Míguez et al., 2022). The 7-item questionnaire uses a 7-point Likert scale (0 = "never true" to 7 = "always true"), with higher scores indicating greater levels of psychological distress.The total score ranges from 7 to 49, with higher scores indicating greater experiential avoidance and psychological inflexibility, while lower scores reflect higher psychological flexibility. This scale is commonly used in clinical and research settings to evaluate mental health and intervention outcomes.
UCLA Loneliness Scale (Spanish version):
Time frame: Participants will complete questionnaires at 2 time points: just before treatment and after de last treatment (3 days after the first time frame)
The Spanish version of the Three-Item Loneliness Scale will be administered to assess perceived social isolation. Participants rated each of the three items on a 3-point scale, with 1 meaning "never" and 3 meaning "frequently." This scale helped to explore the role of social support and perceived isolation in recovery from physical exertion.The scale consists of 20 items, each rated on a 4-point Likert scale: 1. (Never) 2. (Rarely) 3. (Sometimes) 4. (Often) The total score ranges from 20 to 80, with higher scores indicating greater levels of loneliness. There is no strict cutoff, but higher scores generally reflect more significant perceived loneliness.
Zung Self-Rating Depression Scale (Spanish version):
Time frame: Participants will complete questionnaires at 2 time points: just before treatment and after de last treatment (3 days after the first time frame)
This self-applied scale contains 20 items designed to assess the severity of depressive symptoms, with both positive and negative formulations. The Zung scale's high specificity (over 80%) makes it a reliable tool for evaluating depression levels in the study's population (Carreira-Míguez et al., 2022). These baseline psychological assessments enabled the researchers to correlate psychological variables with recovery markers throughout the study.t consists of 20 questions, each evaluating various aspects of depression, including mood, physical symptoms, and psychomotor activity. Scoring Each question is rated on a 4-point Likert scale: 1. (A little of the time) 2. (Some of the time) 3. (Good part of the time) 4. (Most of the time) The total score ranges from 20 to 80, with higher scores indicating more severe depression: 20-44: Normal range 45-59: Mild depression 60-69: Moderate to marked depression 70-80: Severe depression
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 3 Mar 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electromagnetic stimulation in people with Recovery, Psychological and Transcranial Magnetic Stimulation, run by Sierra Varona SL at 1 site in Spain.
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 8 inclusion and 1 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 3 Mar 2025. 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 Spain. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Big Five Personality Trait Short Questionnaire (Spanish version) (time frame: Participants will complete questionnaires at 2 time points: just before treatment and after de last treatment (3 days after the first time frame).). The study lists 5 primary outcomes in all. 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 3 Mar 2025.