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

Sciatica Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03801512
• Other study ID #: N201805024
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: May 28, 2024

Study information

• Verified date: April 2024
• Source: Taipei Medical University Hospital
• Contact: Meng-Huang Wu, PhD
• Phone: 886 2 27372181
• Email: 141036[@]h.tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 28, 2024
• Est. primary completion date: May 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Female or male, 20 to 80 years of age.

2. 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.

3. Participants whose sciatica symptom doesn't have occur time limit.

4. Participants who agreed to follow the trial protocol.

5. Participants who could complete the study treatment and assessments.

6. Participants who had steroid or pain control injection can participate the study after receiving injection more than 3 days.

Exclusion Criteria:

1. Participants with severe progressive neurological symptoms (e.g. cauda equina compression).

2. Participants who had undergone surgery for lumbar disc herniation within 6 months.

3. Participants whose sciatica symptom wasn't caused by lumbar radiculopathy.

4. Participants with cardiovascular, liver, kidney, or hematopoietic system diseases, severe psychiatric or psychological disorder, or cancer.

5. Women who were pregnant.

6. Participants with a pacemaker, metal allergy, or severe fear of needles.

Related Conditions & MeSH terms

• Sciatica

Intervention

Other:
• Steroid
Triamcinolone 1pc + lidocaine 1% 1cc inject at neuritis nerve roots
• Acupuncture
1.5 inch acupuncture needles insert at acupoints BL23, BL24, BL25 and BL26
• Platelet Rich Plasma
Inject investigators Platelet Rich Plasma at neuritis nerve roots

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Abbasipour-Dalivand S, Mohammadi R, Mohammadi V. Effects of Local Administration of Platelet Rich Plasma on Functional Recovery after Bridging Sciatic Nerve Defect Using Silicone Rubber Chamber; An Experimental Study. Bull Emerg Trauma. 2015 Jan;3(1):1-7. — View Citation

Centeno C, Markle J, Dodson E, Stemper I, Hyzy M, Williams C, Freeman M. The use of lumbar epidural injection of platelet lysate for treatment of radicular pain. J Exp Orthop. 2017 Nov 25;4(1):38. doi: 10.1186/s40634-017-0113-5. — View Citation

Inoue M, Hojo T, Yano T, Katsumi Y. Electroacupuncture direct to spinal nerves as an alternative to selective spinal nerve block in patients with radicular sciatica--a cohort study. Acupunct Med. 2005 Mar;23(1):27-30. doi: 10.1136/aim.23.1.27. — View Citation

Kucuk L, Gunay H, Erbas O, Kucuk U, Atamaz F, Coskunol E. Effects of platelet-rich plasma on nerve regeneration in a rat model. Acta Orthop Traumatol Turc. 2014;48(4):449-54. doi: 10.3944/AOTT.2014.13.0029. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale score	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	2 weeks
Secondary	Numeric Rating Scale (NRS)	An 11-point scale for patient self-reporting of pain scored 0-10 ( 0=no pain, 10= pain as bad as can be)	2 weeks
Secondary	EQ-5D	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.	2 weeks
Secondary	Oswestry Disability Index (ODQ)	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'	2 weeks