SciaticaNCT03801512
Comparing the Efficacy of Steroid, Acupuncture and Platelet Rich Plasma Injection in Patients With Sciatica
A study testing Steroid, Acupuncture and Platelet Rich Plasma in people with Sciatica, run by Taipei Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Sciatica
- What is being tested?
- Steroid, Acupuncture and Platelet Rich Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Apr 2019to 28 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ray-Jade Chen, PhD contact
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, Taiwan, 11031
Meng-Huang Wu, +8862273721813470, maxwutmu@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Sciatica
- Being tested
- Steroid, Acupuncture, Platelet Rich Plasma
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SteroidOther
Triamcinolone 1pc + lidocaine 1% 1cc inject at neuritis nerve roots
AcupunctureOther
1.5 inch acupuncture needles insert at acupoints BL23, BL24, BL25 and BL26
Platelet Rich PlasmaOther
Inject investigators Platelet Rich Plasma at neuritis nerve roots
| Study group | Role | What they receive |
|---|---|---|
| Steroid Injections | Experimental | Inject steroid at neuritis nerve root. Receives: Other: Steroid |
| Acupuncture | Experimental | Acupuncture at acupoints BL23 to BL26. Receives: Other: Acupuncture |
| Platelet Rich Plasma Injection | Experimental | Inject Platelet Rich Plasma at neuritis nerve root. Receives: Other: Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (3)
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)
Measured: 2 weeks
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.
Measured: 2 weeks
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'
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start24 Apr 2019
- Primary completion28 May 2025 (estimated)
- Study completion28 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SciaticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng-Huang Wu, Taipei Medical University Hospital
- Investigators
- Ray-Jade Chen, PhD, Study chair, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801512
- Sponsor's protocol ID
- N201805024
- Status last verified
- Apr 2024
- First submitted
- 9 Jan 2019
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
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.
PubMed 15844437Abbasipour-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.
PubMed 27162893Kucuk 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.
PubMed 25230270Centeno 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.
PubMed 29177632
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03801512
- Acronym / sponsor ID
- N201805024
- Conditions
- Sciatica
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 28 May 2025 (estimated)
- Study completion
- 28 May 2025 (estimated)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Steroid Injections | Experimental | Other: SteroidInject steroid at neuritis nerve root. |
| Acupuncture | Experimental | Other: AcupunctureAcupuncture at acupoints BL23 to BL26. |
| Platelet Rich Plasma Injection | Experimental | Other: Platelet Rich PlasmaInject Platelet Rich Plasma at neuritis nerve root. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SteroidTriamcinolone 1pc + lidocaine 1% 1cc inject at neuritis nerve roots | Other | Steroid Injections |
| Acupuncture1.5 inch acupuncture needles insert at acupoints BL23, BL24, BL25 and BL26 | Other | Acupuncture |
| Platelet Rich PlasmaInject investigators Platelet Rich Plasma at neuritis nerve roots | Other | Platelet Rich Plasma Injection |
Primary outcome
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
3 secondary outcomes
Numeric Rating Scale (NRS)
Time frame: 2 weeks
EQ-5D
Time frame: 2 weeks
Oswestry Disability Index (ODQ)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Results publication: PubMed 15844437Inoue 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.
- Results publication: PubMed 27162893Abbasipour-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.
- Results publication: PubMed 25230270Kucuk 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.
- Results publication: PubMed 29177632Centeno 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ray-Jade Chen, PhD contact
Ray-Jade Chen, PhD study chair
Taipei Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steroid, Acupuncture and Platelet Rich Plasma in people with Sciatica, run by Taipei Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng-Huang Wu, PhD (886 2 27372181 ext. 3740, 141036@h.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale score (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03801512, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.