Evaluating Combined Electromagnetic Stimulation for Enhanced Physical and Psychological Recovery in Athletes with DOMS

Sierra Varona SL

Status: Not yet enrolling

Conditions: Transcranial Magnetic Stimulation; Recovery, Psychological

Treatments: Device: electromagnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06855316

017

Details and patient eligibility

About

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.

Full 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).

Enrollment: 48 estimated patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. be male,
2. aged between 18 and 35 years
3. engage in regular exercise at least three times per week for a minimum of one year
4. have no hypersensitivity to the areas designated for peripheral stimulation
5. be free from chronic conditions incompatible with exercise performance
6. have no recent musculoskeletal injuries to the lower limbs within the past six months,
7. be non-smokers
8. possess the cognitive capacity to understand the study's objectives and procedures.

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 4 patient groups, including a placebo group

control/placebo group

Placebo Comparator group

Description:

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.

Treatment:

Device: electromagnetic stimulation

Super Inductive (P) Group

Experimental group

Description:

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.

Treatment:

Device: electromagnetic stimulation

Transcranial (T) Group

Experimental group

Description:

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.

Treatment:

Device: electromagnetic stimulation

Combined Stimulation (Comb) Group

Experimental group

Description:

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.

Treatment:

Device: electromagnetic stimulation