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

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ClinicalTrials.gov Identifier: NCT03801512
Recruitment Status : Not yet recruiting
First Posted : January 11, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University Hospital

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.

Condition or disease Intervention/treatment Phase
Sciatica Other: Steroid Other: Acupuncture Other: Platelet Rich Plasma Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Sciatica

Arm Intervention/treatment
Experimental: Steroid Injections
Inject steroid at neuritis nerve root.
Other: Steroid
Triamcinolone 1pc + lidocaine 1% 1cc inject at neuritis nerve roots

Experimental: Acupuncture
Acupuncture at acupoints BL23 to BL26.
Other: Acupuncture
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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.


  3. 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'



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • individuals aged 20 to 80 years
  • participants who had dermatome between L3 to S1
  • participants whose straight leg raising test were positiveparticipants 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 lasted less than 6 months
  • participants who agreed to follow the trial protocol
  • participants who could complete the study treatment and assessments

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 with symptoms caused by conditions other than lumbar radiculopathy that might lead to sciatica symptom
  • participants with cardiovascular, liver, kidney, or hematopoietic system diseases, severe psychiatric or psychological disorder, or cancer for whom electrostimulation might be inappropriate or unsafe
  • women who were pregnant
  • participants who were participating in other clinical trials
  • participants with a pacemaker, metal allergy, or severe fear of needles

Information from the National Library of Medicine

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


Contacts
Contact: Meng-Huang Wu, PhD 886 2 27372181 ext 3740 141036@h.tmu.edu.tw
Contact: Ray-Jade Chen, PhD

Locations
Taiwan
Taipei medical university hospital
Taipei, Taiwan, 110
Sponsors and Collaborators
Taipei Medical University Hospital
Investigators
Study Chair: Ray-Jade Chen, PhD Taipei Medical University Hospital

Publications of Results:
Responsible Party: Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT03801512     History of Changes
Other Study ID Numbers: N201805024
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sciatica
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms