Comparing the Efficacy of Steroid Acupuncture and Platelet Rich Plasma Injection in Patients With Sciatica

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    90
  • sponsor
    Taipei Medical University Hospital
Updated on 23 January 2021
ct scan
stenosis
analgesia
acupuncture
lidocaine
MRI
steroid injection
disc prolapse
platelet-rich plasma injection
straight leg raise test

Summary

Disc herniation, stenosis of the spine and spondylolisthesis are the common causes of radiculitis in medical practice today, and can cause symptoms of sciatica. 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.

Description

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.

Details
Condition Sciatica
Treatment Acupuncture, Platelet Rich Plasma, Steroid
Clinical Study IdentifierNCT03801512
SponsorTaipei Medical University Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Female or male, 20 to 80 years of age
Participants who had dermatome between L3 to S1, or participants whose straight leg raising test was positive, or participants had Meyerding Grade I to II spondylolisthesis or herniated intervertebral disc or spinal stenosis diagnosed by X-rays, Magnetic resonance imaging or computed tomography
Participants whose sciatica symptom doesn't have occur time limit
Participants who agreed to follow the trial protocol
Participants who could complete the study treatment and assessments
Participants who had steroid or pain control injection can participate the study after receiving injection more than 3 days

Exclusion Criteria

Participants with severe progressive neurological symptoms (e.g. cauda equina compression)
Participants who had undergone surgery for lumbar disc herniation within 6 months
Participants whose sciatica symptom wasn't caused by lumbar radiculopathy
Participants with cardiovascular, liver, kidney, or hematopoietic system diseases, severe psychiatric or psychological disorder, or cancer
Women who were pregnant
Participants with a pacemaker, metal allergy, or severe fear of needles
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