Therapist-dependent Dose of Spinal TENS

University of Castilla-La Mancha

Status: Unknown

Conditions: Spinal Cord Stimulation; Transcutaneous Electrical Nerve Stimulation; Dose-response Relationship

Treatments: Device: Sham stimulation; Device: Spinal TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT03179488

ddsm22

Details and patient eligibility

About

The intensity used during transcutaneous electrical nerve stimulation (TENS) in both, clinical practice and research studies, is often based on subjective commands such as "strong but comfortable sensation". There is not consensus regarding the effectiveness dose of TENS

Full description

Twenty healthy volunteers will divide into two groups: Therapist 1 and Therapist 2. Both therapist will apply spinal TENS and sham stimulation for 40min in random order to each subject, at an intensity to produce a "strong but comfortable sensation".

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers between 18 and 60 years old

Exclusion criteria

• Musculoskeletal pathology of the lower limbs
• History of neuromuscular disease
• Unable to tolerate electrical current
• Allergy to the electrode material
• Pacemaker or any implanted device
• Epilepsy
• Neurotrauma
• Recent surgical procedures
• Pain affecting the lower limbs or lower back
• Diabetes
• Pregnancy
• Cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Spinal TENS stimulation

Experimental group

Description:

Spinal TENS stimulation: A constant voltage and a symmetric biphasic current of 200 microseg pulse-width at a frequency of 100Hz. The intensity will increase until participants report a "strong but comfortable" sensation, just below motor threshold.

Treatment:

Device: Spinal TENS

Sham stimulation

Sham Comparator group

Description:

The same procedures as experimental group, but but will be applied a sham electrical stimulation increasing the current intensity until sensory perception of the stimulus, and then decreased to zero where it will fix until the end of the stimulation.

Treatment:

Device: Sham stimulation