ABSTRACT
Purpose:
Chinese herbal medicine and
electroacupuncture (EA) have been used to control
pain for many decades in
China. We aim to explore the
efficacy of intervening
patients whose discogenic
sciatica symptoms lasting longer than 3 months with these
conservative treatments.
Patients and
Methods:
This is a single-center, parallel-group,
patient-unblinded
Randomized Controlled Trial (RCT) with blinded
outcome assessment and statistician. One hundred and twenty-four
patients will be assigned randomly into 2 groups including
conservative treatment group (Shenxie Zhitong
capsule combined with EA
treatment) and Nonsteroidal Anti-inflammatory
Drugs (Nonsteroidal Anti-inflammatory
Drugs,
NSAIDs)
control group (
Celecoxib) in a 11 ratio. The trial involves a 4-week
treatment along with follow-up for 6 months. The primary outcome is the
leg pain intensity measured by the visual analogue scale (VAS) at 6 months after
randomization.
Secondary outcomes include
leg pain intensity at other
time points,
back pain intensity,
leg pain and
back pain frequency,
functional status,
quality of life,
return to work status and
satisfaction of
patients. Adverse events
will also be recorded. Strengths and Limitations of This Study Through this study, we want to observe the
efficacy of
electroacupuncture combined with
Chinese herbal medicine on
pain intensity for chronic
sciatica secondary to Lumbar
Disc Herniation. If the final results are favorable, it is expected to be a safe, economical, and effective
treatment for
patients. The study design has the following
limitations:
the setup of
control group was less than perfect;
patients and doctors could not be blinded in this trial; we skipped the
feasibility study. We have tried our best to minimize adverse impacts. Trial Registration ChiCTR2300070884 (
Chinese Clinical Trial Registry, http//www.chictr.org.cn, registered on 25th April 2023).
