Therapist-dependent Dose of Spinal TENS

NCT03179488 | Unknown

• 1 other identifier: ddsm22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Baseline Current Density

  Current density (mA/cm2) is obtained by a mathematical operation which reflects the applied current intensity divided by the electrode area (45cm2)

  At the onset (0min) of the Spinal TENS session

• Final Current Density

  Current density (mA/cm2) is obtained by a mathematical operation which reflects the applied current intensity divided by the electrode area (45cm2)

  At the end (40min) of the Spinal TENS session

Secondary Outcomes (9)

• Baseline Maximal peak-to-peak soleus H-reflex

  baseline at 0min

• Baseline Maximal peak-to-peak soleus M wave

  baseline at 0min

• Baseline Normalized H-reflex response

  baseline at 0min

• During Maximal peak-to-peak soleus H-reflex

  during treatment at 33min

• During Maximal peak-to-peak soleus M wave

  during treatment at 33min

Study Arms (2)

Spinal TENS stimulation

EXPERIMENTAL

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.

Device: Spinal TENS

Sham stimulation

SHAM COMPARATOR

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.

Device: Sham stimulation

Interventions

Spinal TENS DEVICE

Spinal TENS stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Spinal TENS stimulation

Sham stimulation DEVICE

Sham stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers between 18 and 60 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Hospital Nacional de Parapléjicos de Toledo: collaborator

Study Sites (1)

Juan Avendaño-Coy

Toledo, 45071, Spain

RECRUITING

Study Officials

• Juan Avendaño-Coy, PhD

  University of Castilla-La Mancha

  STUDY DIRECTOR

• Diego Serrano-Muñoz, MsC

  Hospital Nacional de Parapléjicos de Toledo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julio Gómez-Soriano, PhD

CONTACT

0034 925268800; Julio.Soriano@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, crossover trial

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 7, 2017
• Study Start: July 3, 2017
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: July 5, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)