SpasticityNCT02718690
Importance of the Current Density in TENS
A study testing TENS in people with Spasticity, run by University of Castilla-La Mancha.
Trial summary
The purpose of this study is demonstrate the importance of density current of TENS in the effect about H-reflex in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Spasticity
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.
Who cannot join
- Neuromuscular disease.
- Epilepsy.
- Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
- Osteosynthesis material in the upper limb.
- Diabetes.
- Cancer.
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- Cardiovascular disease.
- Pacemaker or other implanted electrical device.
- Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
- Presence of tattoos or other external agent introduced into the treatment or assessment area.
- Pregnancy.
- Sensitivity disturbance in lower limb.
About this study
Official title: Importance of the Current Density: Effects of TENS About H-reflex. A Pilot Study
The purpose of this study is demonstrate the importance of density current of TENS in the effect about H-reflex in healthy volunteers.
Read the detailed description
TENS have been used to treatment against pain and reflex modulation. However, the most part of evidence do not show the current density. This parameter has been demonstrated like a important factor in the effect of the current about the outcome measures.
This study show the difference between the same subjective sensation "strong but comfortable" in current density and the relation with the effect about H-reflex.
- Conditions
- Spasticity
- Being tested
- TENS, Sham stimulation
- Keywords
- H-Reflex, Current Density, TENS
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
TENS transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Sham stimulationDevice
Sham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous nerve stimulation | Experimental | Transcutaneous application of TENS current over the back for a 40 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold. Receives: Device: TENS |
| Sham stimulation | Sham comparator | Electrodes are placed over the back for a 40 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline H reflex
H-reflex data are obtained by EMG signal. The EMG electrode (SignalConditioningElectrodes v2.3, Delsys Inc., USA) is fixed on triceps surae by the SENIAM protocol (www.seniam.org). The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
Measured: baseline at 0 min.
During treatment H reflex
H-reflex data are obtained by EMG signal. The EMG electrode (SignalConditioningElectrodes v2.3, Delsys Inc., USA) is fixed on triceps surae by the SENIAM protocol (www.seniam.org). The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
Measured: During treatment at 33min.
Post-treatment H reflex
H-reflex data are obtained by EMG signal. The EMG electrode (SignalConditioningElectrodes v2.3, Delsys Inc., USA) is fixed on triceps surae by the SENIAM protocol (www.seniam.org). The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
Measured: Immediately after treatment at 40 min.
Secondary outcomes (1)
Change Current Density
Current density (mA/cm2) is obtained by a mathematical operation. It is the result of the quotient between the current intensity by the area of the electrodes (in this case 45cm²).
Measured: At 1 min. treatment session, at 40 min. treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startDec 2014
- Primary completionFeb 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego Serrano-Muñoz, MsC, Principal investigator, Hospital Nacional de Parapléjicos de Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718690
- Sponsor's protocol ID
- ddsm
- Status last verified
- Mar 2016
- First submitted
- 3 Mar 2016
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of the Current Density: Effects of TENS About H-reflex. A Pilot Study
- ClinicalTrials.gov ID
- NCT02718690
- Acronym / sponsor ID
- ddsm
- Conditions
- Spasticity
- Keywords
- H-Reflex, Current Density, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 Mar 2016 (estimated)
- 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.
The purpose of this study is demonstrate the importance of density current of TENS in the effect about H-reflex in healthy volunteers.
Detailed description
TENS have been used to treatment against pain and reflex modulation. However, the most part of evidence do not show the current density. This parameter has been demonstrated like a important factor in the effect of the current about the outcome measures.
This study show the difference between the same subjective sensation "strong but comfortable" in current density and the relation with the effect about H-reflex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous nerve stimulation | Experimental | Device: TENSTranscutaneous application of TENS current over the back for a 40 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold. |
| Sham stimulation | Sham comparator | Device: Sham stimulationElectrodes are placed over the back for a 40 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.
Key exclusion criteria (12 listed)
- Neuromuscular disease.
- Epilepsy.
- Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
- Osteosynthesis material in the upper limb.
- Diabetes.
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 |
|---|---|---|
| TENSTENS transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) | Device | Transcutaneous nerve stimulation |
| Sham stimulationSham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) | Device | Sham stimulation |
Primary outcome
Baseline H reflex
Time frame: baseline at 0 min.
H-reflex data are obtained by EMG signal. The EMG electrode (SignalConditioningElectrodes v2.3, Delsys Inc., USA) is fixed on triceps surae by the SENIAM protocol (www.seniam.org). The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
During treatment H reflex
Time frame: During treatment at 33min.
H-reflex data are obtained by EMG signal. The EMG electrode (SignalConditioningElectrodes v2.3, Delsys Inc., USA) is fixed on triceps surae by the SENIAM protocol (www.seniam.org). The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
Post-treatment H reflex
Time frame: Immediately after treatment at 40 min.
H-reflex data are obtained by EMG signal. The EMG electrode (SignalConditioningElectrodes v2.3, Delsys Inc., USA) is fixed on triceps surae by the SENIAM protocol (www.seniam.org). The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
1 secondary outcome
Change Current Density
Time frame: At 1 min. treatment session, at 40 min. treatment session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: Yes
Related trials for Spasticity
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Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
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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. This study is not recruiting at the moment.
Diego Serrano-Muñoz, MsC principal investigator
Hospital Nacional de Parapléjicos de Toledo
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Spasticity, run by University of Castilla-La Mancha.
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 1 inclusion and 12 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: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline H reflex (time frame: baseline at 0 min.). The study lists 3 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 12 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.