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

NCT03801512 | Recruiting

• 1 other identifier: N201805024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sciatica

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Numeric Rating Scale (NRS)

  2 weeks

• EQ-5D

  2 weeks

• Oswestry Disability Index (ODQ)

  2 weeks

Study Arms (3)

Steroid Injections

EXPERIMENTAL

Inject steroid at neuritis nerve root.

Other: Steroid

Acupuncture

EXPERIMENTAL

Acupuncture at acupoints BL23 to BL26.

Other: Acupuncture

Platelet Rich Plasma Injection

EXPERIMENTAL

Inject Platelet Rich Plasma at neuritis nerve root.

Other: Platelet Rich Plasma

Interventions

Steroid OTHER

Triamcinolone 1pc + lidocaine 1% 1cc inject at neuritis nerve roots

Steroid Injections

Acupuncture OTHER

1.5 inch acupuncture needles insert at acupoints BL23, BL24, BL25 and BL26

Acupuncture

Platelet Rich Plasma OTHER

Inject investigators Platelet Rich Plasma at neuritis nerve roots

Platelet Rich Plasma Injection

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan, 11031, Taiwan

RECRUITING

Related Publications (4)

• 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.

  PMID: 15844437 BACKGROUND

• 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.

  PMID: 27162893 BACKGROUND

• 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.

  PMID: 25230270 BACKGROUND

• 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.

  PMID: 29177632 BACKGROUND

MeSH Terms

Conditions

Sciatica

Interventions

Steroids; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds; Complementary Therapies; Therapeutics

Study Officials

• Ray-Jade Chen, PhD

  Taipei Medical University Hospital

  STUDY CHAIR

Central Study Contacts

Meng-Huang Wu, PhD

CONTACT

886 2 27372181; 141036@h.tmu.edu.tw

Ray-Jade Chen, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician, Department of Orthopedics

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: April 24, 2019
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)