Spinal Cord Injuries, Neuropathic Pain
Conditions
Brief summary
A prospective case control study to determine the effectiveness and longevity of 8% capsaicin patch(es) in treating neuropathic pain in persons with spinal cord injury. The investigators will study spinal cord injury patients at South Texas Veterans Health Care Systems Spinal Cord Injury inpatient unit and outpatient clinics.
Detailed description
The investigators will recruit \ 20 patients with chronic spinal cord injury (SCI) and chronic neuropathic pain (\>6months) below level of injury who have failed multiple pharmacological agents. Pre-study data collection will include subjective description of pain, baseline visual analog scale (VAS), numeric pain rating scale (NPRS), a numerical scale such as short form (SF) 36 form that measures quality of life parameters, subjective functional independence (FIM) scores, and pain diagrams will be obtained on each participant. Written informed consent will be obtained. After randomization patients will be assigned to a different sequence of treatment. All patients will receive either the treatment and control patches in a randomized order for a total of three treatment periods (control, treatment, treatment for example). When assigned to received treatment arm of study patients will receive Qutenza Capsaicin 8% patch(es) applied for 1 hour after pre- treatment with topical lidocaine. The control group will receive a low dose (0.04%) amount of capsaicin in patch form using an identical application procedure. Investigators will give each patient a diary to self record daily VAS/NPRS scores. Investigators will then schedule routine f/u via telephone call at 2, 4, 8, and 12 weeks post application to accurately report onset of relief and obtain NPRS scores at 2, 4, 8, 12 week points. Patients will follow up in clinic at the end of the 12 week study to repeat data collection using our quality of life scale (SF 36) and FIM scores. Investigators will then use data analysis to record percentage of reduction in NPRS/ VAS, and changes in SF 36 and FIM scores at any given time point vs baseline. For those that continue to have pain relief at 12 week mark we will periodically call every 4 months after study completion to assess for total duration of pain relief for up to 1 year post application.
Interventions
Applied topically for 1 hour
DRUGLow Dose Capsaicin 0.025% Well Patch
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Study participants are assigned to both strengths of the intervention, so all study participants receive both strengths, thus acting as their own control. Data will be compared according to intervention, rather than following each subject from beginning of study through both interventions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
1. Diagnosis of SCI 2. Neuropathic pain below level of injury 3. Surface area of pain no larger than 2 patches 4. Failed or did not tolerate gabapentin 3600mg/day, pregabalin 600mg/day, capsaicin cream and/or lidocaine cream 5. Skin over painful area intact
Exclusion criteria
1. Pain over open wound 2. Previously documented allergy to capsaicin 3. Superficial burn over area of pain 4. Premorbid (before SCI) neuropathic pain 5. HIV/AIDS neuropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Relief With Visual Analog (VAS) Pain Scale | Change in pain at 2,4,6,8, 10 and 12 weeks | The Visual Analog Scale (VAS) was used as the primary outcome measure to quantify pain on a scale of 0-10, with 0 being no pain and 10 being the worst pain. VAS was measured at weeks 2,4,6,8,10 and12 during each 12- week block. |
| Change in Quality of Life as Measured by the World Health Organization Quality of Life (WHOQOL-BREF) | Every 4 weeks for 12 weeks | The World Health Organization Quality of Life (WHOQOL-BREF) questionnaire is a scale used to assess an individual's perception of their quality of life. Its domains include physical health, psychological health, social relationships, and patient environment. It is scored from 0-100, where lower scores indicate poorer perception of quality of life and higher scores indicate better perception. This scale was used to investigate if there was any pattern of change in QOL due to improved pain control. WHO-QOL-BREF was also measured every 4 weeks of each period. |
| Change in Spinal Cord Independence Measure (SCIM) | Every 4 weeks for12 weeks | The Spinal Cord Independence Measure (SCIM) is a reliable scale that measures proficiency of activities of daily living (ADL's) of patients with spinal cord injuries. (28) It is broken up into four subscales including self-care, respiration and sphincter control, and mobility with a total score combining all 3 outcomes. It is scored from 0-100, where lower numbers indicate more dependence on others and higher numbers indicate less dependence. This tool can be applied practically to the study to investigate everyday function before and after patch application. SCIM was administered every 4 weeks of each period. |
Countries
United States
Participant flow
Recruitment details
Study participants will be randomized to either the low dose control capsacin or the higher dose 8% capsacin intervention first, and after 12 weeks, will be assigned to the opposite intervention for 12 weeks so that each person acts as their own control. Data collected will compare only the investigational drug group to the control group.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Demographics All subjects were included in both arms of the study, so demographics are reported together for all participants. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Overall Study Demographics | — |
|---|---|---|
| Age, Continuous | 49.72 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 11 participants | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Change in Pain Relief With Visual Analog (VAS) Pain Scale
The Visual Analog Scale (VAS) was used as the primary outcome measure to quantify pain on a scale of 0-10, with 0 being no pain and 10 being the worst pain. VAS was measured at weeks 2,4,6,8,10 and12 during each 12- week block.
Time frame: Change in pain at 2,4,6,8, 10 and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group | Change in Pain Relief With Visual Analog (VAS) Pain Scale | 2 weeks | 3.586 score on a scale | Standard Error 0.5345 |
| Experimental Group | Change in Pain Relief With Visual Analog (VAS) Pain Scale | 4 weeks | 4.041 score on a scale | Standard Error 0.5345 |
| Experimental Group | Change in Pain Relief With Visual Analog (VAS) Pain Scale | 6 weeks | 4.984 score on a scale | Standard Error 0.554 |
| Experimental Group | Change in Pain Relief With Visual Analog (VAS) Pain Scale | 8 weeks | 4.184 score on a scale | Standard Error 0.554 |
| Experimental Group | Change in Pain Relief With Visual Analog (VAS) Pain Scale | 10 weeks | 4.284 score on a scale | Standard Error 0.554 |
| Experimental Group | Change in Pain Relief With Visual Analog (VAS) Pain Scale | 12 weeks | 4.049 score on a scale | Standard Error 0.5775 |
| Control Group | Change in Pain Relief With Visual Analog (VAS) Pain Scale | 10 weeks | 4.753 score on a scale | Standard Error 0.5769 |
| Control Group | Change in Pain Relief With Visual Analog (VAS) Pain Scale | 2 weeks | 5.494 score on a scale | Standard Error 0.5775 |
| Control Group | Change in Pain Relief With Visual Analog (VAS) Pain Scale | 8 weeks | 4.834 score on a scale | Standard Error 0.5544 |
| Control Group | Change in Pain Relief With Visual Analog (VAS) Pain Scale | 4 weeks | 5.677 score on a scale | Standard Error 0.5345 |
| Control Group | Change in Pain Relief With Visual Analog (VAS) Pain Scale | 12 weeks | 4.311 score on a scale | Standard Error 0.6795 |
| Control Group | Change in Pain Relief With Visual Analog (VAS) Pain Scale | 6 weeks | 5.768 score on a scale | Standard Error 0.5345 |
Primary
Change in Quality of Life as Measured by the World Health Organization Quality of Life (WHOQOL-BREF)
The World Health Organization Quality of Life (WHOQOL-BREF) questionnaire is a scale used to assess an individual's perception of their quality of life. Its domains include physical health, psychological health, social relationships, and patient environment. It is scored from 0-100, where lower scores indicate poorer perception of quality of life and higher scores indicate better perception. This scale was used to investigate if there was any pattern of change in QOL due to improved pain control. WHO-QOL-BREF was also measured every 4 weeks of each period.
Time frame: Every 4 weeks for 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group | Change in Quality of Life as Measured by the World Health Organization Quality of Life (WHOQOL-BREF) | 4 weeks | 79.26 score on a scale | Standard Error 4.092 |
| Experimental Group | Change in Quality of Life as Measured by the World Health Organization Quality of Life (WHOQOL-BREF) | 8 weeks | 80.91 score on a scale | Standard Error 4.204 |
| Experimental Group | Change in Quality of Life as Measured by the World Health Organization Quality of Life (WHOQOL-BREF) | 12 weeks | 74.90 score on a scale | Standard Error 4.092 |
| Control Group | Change in Quality of Life as Measured by the World Health Organization Quality of Life (WHOQOL-BREF) | 4 weeks | 80.91 score on a scale | Standard Error 4.092 |
| Control Group | Change in Quality of Life as Measured by the World Health Organization Quality of Life (WHOQOL-BREF) | 8 weeks | 85.42 score on a scale | Standard Error 4.207 |
| Control Group | Change in Quality of Life as Measured by the World Health Organization Quality of Life (WHOQOL-BREF) | 12 weeks | 87.42 score on a scale | Standard Error 4.207 |
Primary
Change in Spinal Cord Independence Measure (SCIM)
The Spinal Cord Independence Measure (SCIM) is a reliable scale that measures proficiency of activities of daily living (ADL's) of patients with spinal cord injuries. (28) It is broken up into four subscales including self-care, respiration and sphincter control, and mobility with a total score combining all 3 outcomes. It is scored from 0-100, where lower numbers indicate more dependence on others and higher numbers indicate less dependence. This tool can be applied practically to the study to investigate everyday function before and after patch application. SCIM was administered every 4 weeks of each period.
Time frame: Every 4 weeks for12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group | Change in Spinal Cord Independence Measure (SCIM) | 4 weeks | 20.32 score on a scale | Standard Error 0.9886 |
| Experimental Group | Change in Spinal Cord Independence Measure (SCIM) | 8 weeks | 20.70 score on a scale | Standard Error 1.0132 |
| Experimental Group | Change in Spinal Cord Independence Measure (SCIM) | 12 weeks | 19.23 score on a scale | Standard Error 0.9886 |
| Control Group | Change in Spinal Cord Independence Measure (SCIM) | 12 weeks | 18.86 score on a scale | Standard Error 1.014 |
| Control Group | Change in Spinal Cord Independence Measure (SCIM) | 4 weeks | 18.86 score on a scale | Standard Error 0.9886 |
| Control Group | Change in Spinal Cord Independence Measure (SCIM) | 8 weeks | 18.66 score on a scale | Standard Error 1.014 |