Therapist-dependent Dose of Spinal TENS

July 3, 2017 updated by: University of Castilla-La Mancha

Intensity Matters: Therapist-dependent Dose of Spinal Transcutaneous Electrical Nerve Stimulation

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

Study Overview

Detailed 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".

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Toledo, Spain, 45071
        • Recruiting
        • Juan Avendaño-Coy
        • Contact:
          • Juan Avendaño-Coy, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spinal TENS stimulation
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.
Spinal TENS stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Sham Comparator: Sham stimulation
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.
Sham stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline Current Density
Time Frame: At the onset (0min) of the Spinal TENS session
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
Time Frame: At the end (40min) of the Spinal TENS session
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline Maximal peak-to-peak soleus H-reflex
Time Frame: baseline at 0min
H-reflex data are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
baseline at 0min
Baseline Maximal peak-to-peak soleus M wave
Time Frame: baseline at 0min
M wave ddata are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
baseline at 0min
Baseline Normalized H-reflex response
Time Frame: baseline at 0min
Normalized H-reflex response data are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
baseline at 0min
During Maximal peak-to-peak soleus H-reflex
Time Frame: during treatment at 33min
H-reflex data are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
during treatment at 33min
During Maximal peak-to-peak soleus M wave
Time Frame: during treatment at 33min
M wave data are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
during treatment at 33min
During Normalized H-reflex response
Time Frame: during treatment at 33min
Normalized H-reflex response data are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
during treatment at 33min
Post-treatment Maximal peak-to-peak soleus H-reflex
Time Frame: Immediately after treatment at 40 min
H-reflex data are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
Immediately after treatment at 40 min
Post-treatment Maximal peak-to-peak soleus M wave
Time Frame: Immediately after treatment at 40 min
M wave data are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
Immediately after treatment at 40 min
Post-treatment Normalized H-reflex responseMaximal peak-to-peak soleus H-reflex
Time Frame: Immediately after treatment at 40 min
Normalized H-reflex response data are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
Immediately after treatment at 40 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Juan Avendaño-Coy, PhD, University of Castilla-La Mancha

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2017

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

June 5, 2017

First Submitted That Met QC Criteria

June 5, 2017

First Posted (Actual)

June 7, 2017

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

July 3, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • ddsm22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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