Low Back Pain
Conditions
Keywords
nonspecific low back pain, chronic low back pain
Brief summary
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.
Detailed description
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.
Interventions
DEVICEScrambler
Electrotherapy
Sponsors
National Institute of Nursing Research (NINR)
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* be 18-50 years of age * diagnosed with persistent nonspecific LBP * comprehend English
Exclusion criteria
* \<18 or \>50 years of age * chronic pain at another site or associated with a painful condition * pregnant or within 3 months post-partum * implanted drug delivery system * heart stents or metal implants such as pacemakers, automatic defibrillator, aneurysm clips, vena cave slips, or skull plates * history of myocardial infarction or ischemic heart disease within the past six months * history of epilepsy * skin conditions such as open sores that would prevent proper application of electrodes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Worst Low Back Pain Score | baseline to 3 weeks post-treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Scrambler Therapy Scrambler therapy applied to region of low back pain for 30 minutes x 10 days
Scrambler: Electrotherapy | 15 |
| Sham Scrambler Treatment Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days
Scrambler: Electrotherapy | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Scrambler Therapy | Sham Scrambler Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 19 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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.
Time frame: baseline to 3 weeks post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scrambler Therapy | Worst Low Back Pain Score | Baseline Mean Worse Pain Score | 5.4 units on a scale | Standard Deviation 2.1 |
| Scrambler Therapy | Worst Low Back Pain Score | 3-week post-treatment mean worst pain score | 3.2 units on a scale | Standard Deviation 1.2 |
| Sham Scrambler Treatment | Worst Low Back Pain Score | Baseline Mean Worse Pain Score | 4.9 units on a scale | Standard Deviation 1.5 |
| Sham Scrambler Treatment | Worst Low Back Pain Score | 3-week post-treatment mean worst pain score | 5.8 units on a scale | Standard Deviation 1.7 |
p-value: <0.001ANOVA