Comparing the Efficacy of Steroid, Acupuncture and Platelet Rich Plasma Injection in Patients With Sciatica
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03801512|
Recruitment Status : Not yet recruiting
First Posted : January 11, 2019
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sciatica||Other: Steroid Other: Acupuncture Other: Platelet Rich Plasma||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparing the Efficacy of Transforaminal Epidural Injections, Acupuncture and Platelet Rich Plasma Injection in Patients With Sciatica Due to Intervertebral Disc Herniation, Spinal Stenosis and Spondylolisthesis|
|Estimated Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Steroid Injections
Inject steroid at neuritis nerve root.
Triamcinolone 1pc + lidocaine 1% 1cc inject at neuritis nerve roots
Acupuncture at acupoints BL23 to BL26.
1.5 inch acupuncture needles insert at acupoints BL23, BL24, BL25 and BL26
Experimental: Platelet Rich Plasma Injection
Inject Platelet Rich Plasma at neuritis nerve root.
Other: Platelet Rich Plasma
Inject investigators Platelet Rich Plasma at neuritis nerve roots
- visual analogue scale score [ Time Frame: 2 weeks ]Self reported pain intensity: 1. scales with a middle point, graduations or numbers; 2. meter-shaped scales; 3. "box-scales" consisting of circles equidistant from each other; 4. scales with descriptive terms at intervals along a line
- Numeric Rating Scale (NRS) [ Time Frame: 2 weeks ]An 11-point scale for patient self-reporting of pain scored 0-10 ( 0=no pain, 10= pain as bad as can be)
- EQ-5D [ Time Frame: 2 weeks ]
The EQ-5D questionnaire has two components: health state description and evaluation.
In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are.
- Oswestry Disability Index (ODQ) [ Time Frame: 2 weeks ]The Oswestry Disability Index (ODQ) has ten sections: pain, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling. Respondents choose one of six statements that most applies to them in each section. The first statement is scored 0, the second is scored 1, and so on to 5 for the sixth statement. The sum of the section scores is transformed to a percentage score, adjusted for missed sections. The total possible score ranges 0-100 and a higher score indicates worse function. Scores from 0-20% are claimed to indicate 'minimal disability', 20-40% 'moderate disability', 40-60% 'severe disability', 60-80% 'crippled', and 80-100% 'bedbound or exaggerating'
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801512
|Contact: Meng-Huang Wu, PhD||886 2 27372181 ext firstname.lastname@example.org|
|Contact: Ray-Jade Chen, PhD|
|Taipei medical university hospital|
|Taipei, Taiwan, 110|
|Study Chair:||Ray-Jade Chen, PhD||Taipei Medical University Hospital|