Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SCRA-LBP | Other Identifier | VCU |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This pilot study will evaluate Scrambler therapy and Sham treatment on levels of low back pain, pain sensitivity and mRNA expression of pain sensitivity candidate genes.
This pilot study will evaluate the feasibility of the experimental protocol and provide sufficient pilot data to estimate statistical power and sample size requirements. The study will include 30 individuals (15 per group) diagnosed with persistent low back pain who will receive a standard protocol of Scrambler therapy or sham treatment. Participant data will include subjective measures of low back pain, pain sensitivity using quantitative sensory testing, and mRNA expression levels of pain sensitivity candidate genes at baseline (prior to treatment) and 1 and 3 weeks post-treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scrambler therapy | Experimental | Scrambler therapy applied to region of low back pain for 30 minutes x 10 days |
|
| Sham Scrambler treatment | Sham Comparator | Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scrambler | Device | Electrotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Worst Low Back Pain Score | Low back pain will be measured by the Brief Pain Inventory (BPI). The BPI assesses the severity of pain, location of pain, pain medications, amount of pain relief in the past 24 hours and the past week, and the impact of pain on daily functions. For this study, the worst pain score will be used in the analysis. The worst pain score is rated from "0" meaning no pain to "10" meaning pain as bad as you can imagine. | baseline to 3 weeks post-treatment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Angela Starkweather, PhD, ACNP-BC | Virginia Commonwealth University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University School of Nursing | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25572279 | Derived | Starkweather AR, Coyne P, Lyon DE, Elswick RK Jr, An K, Sturgill J. Decreased low back pain intensity and differential gene expression following Calmare(R): results from a double-blinded randomized sham-controlled study. Res Nurs Health. 2015 Feb;38(1):29-38. doi: 10.1002/nur.21632. Epub 2015 Jan 8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Scrambler Therapy | Scrambler therapy applied to region of low back pain for 30 minutes x 10 days Scrambler: Electrotherapy |
| FG001 | Sham Scrambler Treatment | Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days Scrambler: Electrotherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Scrambler Therapy | Scrambler therapy applied to region of low back pain for 30 minutes x 10 days Scrambler: Electrotherapy |
| BG001 | Sham Scrambler Treatment | Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days Scrambler: Electrotherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Worst Low Back Pain Score | Low back pain will be measured by the Brief Pain Inventory (BPI). The BPI assesses the severity of pain, location of pain, pain medications, amount of pain relief in the past 24 hours and the past week, and the impact of pain on daily functions. For this study, the worst pain score will be used in the analysis. The worst pain score is rated from "0" meaning no pain to "10" meaning pain as bad as you can imagine. | Posted | Mean | Standard Deviation | units on a scale | baseline to 3 weeks post-treatment |
|
1 month
Information from standard questionnaires, investigator assessment, subjective measures of low back pain, and pain sensitivity levels using quantitative sensory testing will be documented at baseline (prior to treatment) and 1 and 3 weeks post-treatment. This information will be used as a means to assess for any serious or other adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Scrambler Therapy | Scrambler therapy applied to region of low back pain for 30 minutes x 10 days Scrambler: Electrotherapy |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Angela Starkweather | Virginia Commonwealth University | 8048283986 | astarkweathe@vcu.edu |
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days
Scrambler: Electrotherapy
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Sham Scrambler Treatment | Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days Scrambler: Electrotherapy | 0 | 15 | 0 | 15 |
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |