Trial Outcomes & Findings for Trial of Scrambler Therapy or Sham Treatment for Low Back Pain (NCT NCT01896687)
NCT ID: NCT01896687
Last Updated: 2017-06-14
Results Overview
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.
COMPLETED
NA
30 participants
baseline to 3 weeks post-treatment
2017-06-14
Participant Flow
Participant milestones
| Measure |
Scrambler Therapy
Scrambler therapy applied to region of low back pain for 30 minutes x 10 days
Scrambler: Electrotherapy
|
Sham Scrambler Treatment
Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days
Scrambler: Electrotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Scrambler Therapy or Sham Treatment for Low Back Pain
Baseline characteristics by cohort
| Measure |
Scrambler Therapy
n=15 Participants
Scrambler therapy applied to region of low back pain for 30 minutes x 10 days
Scrambler: Electrotherapy
|
Sham Scrambler Treatment
n=15 Participants
Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days
Scrambler: Electrotherapy
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 3 weeks post-treatmentLow 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.
Outcome measures
| Measure |
Scrambler Therapy
n=15 Participants
Scrambler therapy applied to region of low back pain for 30 minutes x 10 days
Scrambler: Electrotherapy
|
Sham Scrambler Treatment
n=15 Participants
Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days
Scrambler: Electrotherapy
|
|---|---|---|
|
Worst Low Back Pain Score
Baseline Mean Worse Pain Score
|
5.4 units on a scale
Standard Deviation 2.1
|
4.9 units on a scale
Standard Deviation 1.5
|
|
Worst Low Back Pain Score
3-week post-treatment mean worst pain score
|
3.2 units on a scale
Standard Deviation 1.2
|
5.8 units on a scale
Standard Deviation 1.7
|
Adverse Events
Scrambler Therapy
Sham Scrambler Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place