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| ID | Type | Description | Link |
|---|---|---|---|
| 90SI5023 | Other Grant/Funding Number | Nat. Institute on Disability, Indep. Living, and Rehab. Res. |
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Difficulty with recruitment
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| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TENS | Experimental | Participants are given 30 minutes of TENS therapy twice a week for 8 weeks. |
|
| Sham TENS | Sham Comparator | Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Number of participants reporting adverse events related to study treatment as evaluated by physician | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Special populations:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Felix, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active TENS | Participants are given 30 minutes of TENS therapy twice a week for 8 weeks. TENS: TENS 7000 - : TENS will apply low-level electrical current via four pads, two applied paraspinally at the level of spinal cord injury, and two applied on the ventral side of the body 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 |
| FG001 | Sham TENS | Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation. Sham TENS: Inactive electrodes - for two 15 minute trials, neither high nor low frequency. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active TENS | Participants are given 30 minutes of TENS therapy twice a week for 8 weeks. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years at entry into study |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Analyses were performed were on all participants enrolled in each arm using the "last observation carried forward" process. | Posted | Number | percentage of participants | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active TENS | Participants are given 30 minutes of TENS therapy twice a week for 8 weeks. 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| episode of severe nerve pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Felix | University of Miami | 305-243-4497 | efelix@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2022 | Jul 1, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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|
| Sham TENS | Other | Inactive electrodes - for two 15 minute trials, neither high nor low frequency. |
|
| 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 | 12 months |
| BG001 | Sham TENS | Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation. Sham TENS: Inactive electrodes - for two 15 minute trials, neither high nor low frequency. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Sham TENS |
Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation. Sham TENS: Inactive electrodes - for two 15 minute trials, neither high nor low frequency. |
|
|
| Primary | 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 | Analyses were performed were on all participants enrolled in each arm using the "last observation carried forward" process. | Posted | Median | Inter-Quartile Range | score on a scale | 12 months |
|
|
|
| Secondary | Number of Participants With Adverse Events | Number of participants reporting adverse events related to study treatment as evaluated by physician | Analyses were performed were on all participants enrolled in each arm using the "last observation carried forward" process. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | 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. | Analyses were performed were on all participants enrolled in each arm using the "last observation carried forward" process. | Posted | Median | Inter-Quartile Range | score on a scale | 12 months |
|
|
|
| Secondary | 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 | Analyses were performed were on all participants enrolled in each arm using the "last observation carried forward" process. | Posted | Median | Inter-Quartile Range | score on a scale | 12 months |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 4 |
| 13 |
| EG001 | Sham TENS | Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation. Sham TENS: Inactive electrodes - for two 15 minute trials, neither high nor low frequency. | 0 | 13 | 0 | 13 | 4 | 13 |
| broken foot | Injury, poisoning and procedural complications | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| increased pain | General disorders | Systematic Assessment |
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| prolonged dysesthesia | General disorders | Systematic Assessment |
|
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| D014947 | Wounds and Injuries |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |