 Treating Spinal Cord Injury Pain with Cranial
Electrotherapy StimulationAuthors: G Tan, PhD1,2
DH Rintala, PhD1,2 J Thornby, PhD1,2
J. Yang, MD3 WH Wade, MD1,2
C Vasilev4
1. Michael E. DeBakey Veterans Affairs Medical
Center
2. Baylor College of Medicine, Dept. of PM&R
3. Washington, DC Veterans Affairs Medical Center
4. University of Texas M. D. Anderson Cancer Center
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INTRODUCTION
Chronic pain is a serious problem
following spinal cord injury (SCI) and a major impediment to
successful rehabilitation. Cranial electrotherapy stimulation (CES)
has been shown to “normalize” neurotransmitter homeostasis, stimulate
the hypothalamic-pituitary axis by increasing IGF-1 production, and
bring neurotransmitters in stressed subjects to normal levels of
homeostasis. Recent studies have shown CES to be effective in
reducing pain and enhancing quality of life of chronic pain sufferers
with a number of pain conditions, including fibromyalgia,
which has a centrally mediated pain
component. A pilot study was undertaken to assess the effectiveness of
CES in persons with SCI.
PROCEDURE
1. Recruited veterans with SCI known to have pain
from the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC)
SCI registry via telephone
2. Obtained informed consent and pre-treatment data in person at the
MEDVAMC (See Measures below)
3. For each participant’s worst pain (study target pain), a physician
determined whether it was neuropathic or musculoskeletal
4. Trained participants in the use of the cranial electrotherapy
device and daily pain rating sheet
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5. Randomized (double blind) participants into Sham and
Active groups
6. Participants used the device one hour per day for 21 consecutive
days and completed the Daily Pain Rating Sheet before and after each
session
7. Contacted participants weekly by telephone to assure compliance,
identify and solve any problems, and answer questions
8. Obtained post-treatment data in person at the MEDVAMC and collected
the device and the daily pain rating sheet
9. Provided an open-label device to Sham group to use for another 21
days, which allowed participants to adjust the level of stimulation
10. Obtained post-open-label data from Sham group in person at the
MEDVAMC and collected the device and the daily pain rating sheet
MEASURES
1. Demographic information
2. Level and completeness of injury from medical records
3. Brief Pain Inventory (BPI) – Pain Intensity and Pain Interference
scales
4. Daily Pain Rating Sheet – Numeric pain intensity on 0 – 10 scale
before and after each daily session
RESULTS
Brief Pain Inventory - Pain Intensity – 0 to 10 Scale
Pain decreased more in the Active group than in the
Sham group for pain at its worst, average pain,
and least pain, however the differences were not statistically
significant. Change from pre- to post- treatment within the Active
group approached significance (p < .10) for worst and average pain.
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Composite Pain Intensity (0 to 40
scale) and Pain Interference Scores (0 to 100 scale)
Decrease in pain intensity approached significance
in a within-group paired t-test. Pain interference in daily activities
had a main effect of time and a time by group interaction.
Interference decreased
significantly in the Active CES group, but not in the Sham CES group.
Pain Ratings Before and After Each Daily Session – 0 to 10 Scale
Pain was reduced after the sessions in the Active
group and in the Open-Label treatment for the Sham group. An
independent-samples t-test comparing Active and Sham average daily
change was significant (-.73 vs. -.08, p = .034).
CONCLUSIONS
Based on reported pain reduction pre and post each
session, the Active CES treatment was found to be significantly more
efficacious than the Sham treatment with a moderate to large effect
size (Cohen’s d = .76). Future studies will be needed to evaluate the
long-term effectiveness of CES.
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