Steroid injection, acupuncture and platelet-rich plasma injection are often used
interventions for the treatments of sciatica. The investigators will investigate the
efficacy and safety of steroid injection, acupuncture and platelet-rich plasma injection
for sciatica in this single center, parallel, randomized-controlled clinical trial.
Participants will be randomized into 3 groups (steroid injection, acupuncture and
platelet-rich plasma injection) by central allocation. Randomized participants will
complete a questionnaire that solicited information regarding age, sex, marital status,
occupation, education, and medical history. The blinding credibility of the treatments
will be evaluated at the end of the treatment.
Participants in steroid injection group will receive Triamcinolone 1pc plus lidocaine 1%
1cc injection at neuritis nerve roots. Participants in platelet-rich plasma injection
group will receive 15cc blood draw first to concentrate into platelet-rich plasma and
then inject at neuritis nerve roots. Participants in acupuncture group received
standardized acupuncture treatment. hat treatment was accomplished by selecting a group
of acupuncture points that predefined. Acupuncture points will be bladder meridian
pattern acupuncture points including Shenshu (BL23), Qihaishu (BL24), Dachangshu (BL25),
and Guanyuanshu(BL26). The needles will be inserted perpendicular to a depth of 5 to 35
mm depending on the acupuncture point, which was followed by manual stimulation by
bidirectional rotation to induce Deqi sensation. Deqi was defined as a dull, localized,
and aching sensation, which signaled the attainment of qi.
Outcome Measures Primary Outcome Measure The primary outcome measure is visual analogue
scale for sciatica. To understand the impact of sciatica on the participants' life,
visual analogue scale for bothersomeness is chosen instead of pain intensity. The
participants will be asked to mark, on a 10 cm visual analogue scale (0, absence of
bothersomeness; 10, the worst bothersomeness imaginable), the average degree of
bothersomeness due to sciatica experienced within the most recent 1 week from the day of
the assessment. This measurement has substantial validity. Bothersomeness of sciatica
will be measured at baseline, 1-, 2-, 4-, 8-, 12-, 16-, and 24-week.
Secondary Outcome Measures Numeric Rating Scale for pain intensity is a simple method
evaluating the subjective intensity of pain. Pain intensity will be measured in the same
way as visual analogue scale for bothersomeness. Validity of its reliability has been
demonstrated. The Chinese version Oswestry Disability Index is used to measure back
pain-related dysfunction. Health-related quality of life will be measured using the
well-validated EuroQol 5 dimensions (EQ-5D). A higher score is indicative of a better
general health status. Participants satisfaction will be evaluated with 5 point scale (1
is worst, and 5 is best)
We will perform the Shapiro-Wilk normality test to determine whether or not the sample
values followed a normal distribution and finally assumed normality according to the test
result. For the description of baseline characteristics, mean with standard deviation
(SD) for continuous data and frequency with percentage for dichotomous data will be
described. Also, for the homogeneity test of baseline characteristics between 3 groups,
2-sample t tests for continuous data and chi-square test for dichotomous data will be
performed. A mixed-model approach of repeated-measures 2-factor analysis will be used to
analyze the difference and mean change in baseline, 1-, 2-, 4-, 8-, 12-, 16-, and 24-week
visual analogue scale score, Oswestry Disability Index, EQ-5D, patient satisfaction
difference and mean change between groups, interaction between groups, and periods.