Spinal Cord InjuriesTENSNCT03267810
TENS Trial to Prevent Neuropathic Pain in SCI
A study testing TENS in people with Spinal Cord Injuries, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to: 1) test whether transcutaneous electrical nerve stimulation (TENS) after spinal cord injury can reduce the onset of post-injury neuropathic pain; and 2) to learn more about this kind of pain and who is at risk for suffering from this type of pain after spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- 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
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 4 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18;
- Traumatic spinal cord injury;
- Date of injury occurring within four months of study enrollment.
Who cannot join
- More than four months since date of injury;
- Contraindications for the study intervention, transcutaneous electrical nerve stimulation (TENS),88 including:
- Implanted electronic device such as a pacemaker;
- Cardiovascular problems;
- Pregnancy;
- Epilepsy;
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- Cancer;
- Persons with a spinal cord injury at the C2 level, as placement of TENS electrodes on the neck is not recommended;
- Cognitive dysfunction which limits the ability of the participant to adequately understand procedures and risks.
- Prisoners
- Pregnant Women
- Special populations:
- Adults unable to consent: excluded from study
- Individuals -who are not yet adults: individuals who are less than 18 years old will be excluded from the study
- Pregnant women: Women who are known to be pregnant will not be recruited into the study. A pregnancy test will be administered to females prior to enrollment in TENS (or sham) treatment. Women who become pregnant before or during the 8-week TENS treatment period will be discontinued from the study. Women who become pregnant after the 8-week TENS treatment portion of the study will continue to be enrolled, and followed according to protocol guidelines (no information will be collected specifically on the pregnancy or fetus).
- Prisoners: excluded from study
- Neonates: not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blinded, Controlled Trial of Early-intervention TENS for the Reduction of the Prevalence and Severity of Chronic Neuropathic Pain During the First Year After Spinal Cord Injury
The purpose of this research study is to: 1) test whether transcutaneous electrical nerve stimulation (TENS) after spinal cord injury can reduce the onset of post-injury neuropathic pain; and 2) to learn more about this kind of pain and who is at risk for suffering from this type of pain after spinal cord injury. Neuropathic pain is a type of pain that occurs in about 50% of people with spinal cord injury. This type of pain is usually described as "burning" or "tingling," and is present around the level of injury and/or in areas below the level of injury. The investigators' goal is to try a non-drug treatment (TENS) that may help prevent this pain from occurring. Pain symptoms will be compared between the study participants who receive active TENS and the study participants who receive a sham TENS treatment.
- Conditions
- Spinal Cord Injuries
- Being tested
- TENS, Sham TENS
- Keywords
- Neuropathic Pain, Transcutaneous Electrical Nerve Stimulation
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
TENS: TENS 7000 - : TENS applies low-level electrical current via four pads, 2 pads affixed paraspinally, at the level of the spinal cord injury, and 2 affixed on the ventral side to areas within the dermatome corresponding to the level of injury. 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session
Sham TENSOther
Inactive electrodes - for two 15 minute trials, neither high nor low frequency.
| Study group | Role | What they receive |
|---|---|---|
| Active TENS | Experimental | Participants are given 30 minutes of TENS therapy twice a week for 8 weeks. Receives: Device: TENS |
| Sham TENS | Sham comparator | Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation. Receives: Other: Sham TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Subjects Who Develop Chronic Neuropathic Pain.
as defined by a score of ≥2 on the Spinal Cord Injury Pain Inventory (SCIPI), a self-report scale of symptoms. SCIPI has a total score ranging from 0 to 4 with scores of >=2 screening positive for Neuropathic Pain in people with spinal cord injury
Measured: 12 months
Neuropathic Pain Symptom Inventory (NPSI) Scores
NPSI has a total score ranging from 0 to 100 with the higher score indicating more severe symptoms of neuropathic pain
Measured: 12 months
Secondary outcomes (3)
Number of Participants With Adverse Events
Number of participants reporting adverse events related to study treatment as evaluated by physician
Measured: 12 months
Pain Interference With Function
Self-report composite rating scale of interference of pain with activities, mood, and sleep. This scale has a total score ranging from 0 to 30, with a higher score indicating greater pain interference.
Measured: 12 months
Depressive Symptoms
Patient Health Questionnaire - 9 (PHQ-9) has a total score ranging from 0 to 27, with a higher score indicating greater depressive symptoms
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start14 Aug 2017
- Primary completion4 Mar 2022
- Study completion4 Mar 2022
Why it stopped: Difficulty with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuriesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Elizabeth Felix, University of Miami
- Investigators
- Elizabeth Felix, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267810
- Sponsor's protocol ID
- 20160951
- Other IDs
- 90SI5023
- Acronym
- TENS
- Status last verified
- Jul 2023
- First submitted
- 23 Aug 2017
- Last updated
- 14 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blinded, Controlled Trial of Early-intervention TENS for the Reduction of the Prevalence and Severity of Chronic Neuropathic Pain During the First Year After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03267810
- Acronym / sponsor ID
- TENS / 20160951
- Conditions
- Spinal Cord Injuries
- Keywords
- Neuropathic Pain, Transcutaneous Electrical Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with recruitment
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Posted 22 Jun 2023
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 research study is to: 1) test whether transcutaneous electrical nerve stimulation (TENS) after spinal cord injury can reduce the onset of post-injury neuropathic pain; and 2) to learn more about this kind of pain and who is at risk for suffering from this type of pain after spinal cord injury. Neuropathic pain is a type of pain that occurs in about 50% of people with spinal cord injury. This type of pain is usually described as "burning" or "tingling," and is present around the level of injury and/or in areas below the level of injury. The investigators' goal is to try a non-drug treatment (TENS) that may help prevent this pain from occurring. Pain symptoms will be compared between the study participants who receive active TENS and the study participants who receive a sham TENS treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TENS | Experimental | Device: TENSParticipants are given 30 minutes of TENS therapy twice a week for 8 weeks. |
| Sham TENS | Sham comparator | Other: Sham TENSElectrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18;
- Traumatic spinal cord injury;
- Date of injury occurring within four months of study enrollment.
Key exclusion criteria (17 listed)
- More than four months since date of injury;
- Contraindications for the study intervention, transcutaneous electrical nerve stimulation (TENS),88 including:
- Implanted electronic device such as a pacemaker;
- Cardiovascular problems;
- Pregnancy;
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: TENS 7000 - : TENS applies low-level electrical current via four pads, 2 pads affixed paraspinally, at the level of the spinal cord injury, and 2 affixed on the ventral side to areas within the dermatome corresponding to the level of injury. 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session | Device | Active TENS |
| Sham TENSInactive electrodes - for two 15 minute trials, neither high nor low frequency. | Other | Sham TENS |
Primary outcome
The Percentage of Subjects Who Develop Chronic Neuropathic Pain.
Time frame: 12 months
as defined by a score of ≥2 on the Spinal Cord Injury Pain Inventory (SCIPI), a self-report scale of symptoms. SCIPI has a total score ranging from 0 to 4 with scores of >=2 screening positive for Neuropathic Pain in people with spinal cord injury
Neuropathic Pain Symptom Inventory (NPSI) Scores
Time frame: 12 months
NPSI has a total score ranging from 0 to 100 with the higher score indicating more severe symptoms of neuropathic pain
3 secondary outcomes
Number of Participants With Adverse Events
Time frame: 12 months
Pain Interference With Function
Time frame: 12 months
Depressive Symptoms
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Elizabeth Felix, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Spinal Cord Injuries, run by University of Miami at 1 site in United States.
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 3 inclusion and 17 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: stopped early, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Percentage of Subjects Who Develop Chronic Neuropathic Pain. (time frame: 12 months). The study lists 2 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 14 Jul 2023.