Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy

September 23, 2024 updated by: Xu Zhou, Jiangxi University of Traditional Chinese Medicine

Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy: a Randomized Controlled Trial

Lumbar disc herniation with radiculopathy (LDHR) is the local displacement of the intervertebral disc and its contents beyond the edge of the normal intervertebral disc space, resulting in pain, weakness or numbness in the muscle or dermatomal distribution area. Electroacupuncture is based on obtaining the needling sensation manually and applying electrical stimulation of different frequencies and intensities, aiming to enhance the intensity of acupoint stimulation to improve the effect. As a kind of acupoint stimulation therapy, electroacupuncture has shown analgesic effects in animal experiments. However, at present, the clinical evidence of electroacupuncture applied in the treatment of LDHR is still insufficient. Therefore, this randomized, single-blind, sham electroacupuncture controlled trial aims to evaluate the efficacy and safety of electroacupuncture as a treatment for LDHR.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Nanchang
      • Jiangxi, Nanchang, China, 330006
        • The Affiliated Hospital of Jiangxi University of Chinese Medicine
        • Contact:
          • Xu Zhou Professor, M.D.
          • Phone Number: +86-0791-86363831
          • Email: 88299077@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged from 18 to 70 years old.
  2. With intervertebral disc protrusion confirmed by a MRI or CT, accompanied by radicular pain in the lower extremities.
  3. With a NRS score ≥ 4 points for both low back pain and leg pain, and the pain lasts for at least 3 months;
  4. Voluntarily participating the trial and signing the informed consent form.

Exclusion Criteria:

  1. Previous surgical treatment of the spine.
  2. Received any physical therapy for lumbar disc herniation within the recent 3 months.
  3. Complicated with diseases that can cause low back and leg pain.
  4. Symptomatic foraminal stenosis caused by severe degenerative diseases, accompanied by severe nerve injuries.
  5. Previous severe mental illness, organ failure, or malignant tumor.
  6. Planned spinal surgery or other major surgeries within the next 3 months.
  7. Pregnancy or lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Electroacupuncture
Other: Electroacupuncture
The main acupoints selected for the electroacupuncture group are bilateral BL23, bilateral BL25, bilateral GB30, bilateral LR11, bilateral LR8, GV4, GV3, and the affected BL40, and the secondary acupoints selected are bilateral BL54, the affected side BL57 and the affected side BL60.The treatment will be administered once every other day for 30 minutes each time, lasting for 8 consecutive weeks, totaling 24 sessions.
Sham Comparator: Sham electroacupuncture
Other: Sham electroacupuncture
In the sham electroacupuncture group, the acupoints will be at a position 2 cm lateral to the correct acupoints horizontally. The dosage and treatment course are the same as those in the electroacupuncture group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of responders
Time Frame: Weeks 8 and 24
Definition of a response: a reduction of at least 2 points in the score of the Numerical Rating Scale for both low back pain and leg pain.
Weeks 8 and 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intensity of low back pain
Time Frame: Weeks 2, 4, 8, 16, and 24
Changes from baseline in the intensity of low back pain assessed by the Numerical Rating Scale
Weeks 2, 4, 8, 16, and 24
Intensity of leg pain
Time Frame: Weeks 2, 4, 8, 16, and 24
Changes from baseline in intensity of leg pain assessed by the Numerical Rating Scale
Weeks 2, 4, 8, 16, and 24
Level of disability
Time Frame: Weeks 2, 4, 8, 16, and 24
Changes from baseline in the level of disability assessed by the Roland-Morris Disability Questionnaire
Weeks 2, 4, 8, 16, and 24
Performance status
Time Frame: Weeks 2, 4, 8, 16, and 24
Changes from baseline in functional status assessed by the Japanese Orthopaedic Association Score
Weeks 2, 4, 8, 16, and 24
Severity of depression
Time Frame: Weeks 2, 4, 8, 16, and 24
Changes from baseline in the severity of depression assessed by the Hamilton Depression Rating Scale
Weeks 2, 4, 8, 16, and 24
Severity of anxiety
Time Frame: Weeks 2, 4, 8, 16, and 24
Changes from baseline in the severity of anxiety assessed by the Hamilton Anxiety Rating Scale
Weeks 2, 4, 8, 16, and 24
Sleep quality
Time Frame: Weeks 2, 4, 8, 16, and 24
Changes from baseline in sleep quality assessed by the Insomnia Severity Index
Weeks 2, 4, 8, 16, and 24
Pain self-efficacy
Time Frame: Weeks 2, 4, 8, 16, and 24
Changes from baseline in pain self-efficacy assessed by the Pain self-efficacy questionnaire
Weeks 2, 4, 8, 16, and 24
Use of analgesics
Time Frame: Weeks 8 and 24
The proportion of patients who used analgesics for emergency.
Weeks 8 and 24
Incidence of lumbar spine surgery
Time Frame: Weeks 8 and 24
The incidence of lumbar spine surgery during the follow-up
Weeks 8 and 24
Incidence of any adverse events
Time Frame: Weeks 8 and 24
Adverse events be reported by patients and determined by clinicians.
Weeks 8 and 24
Incidence of treatment-related adverse events
Time Frame: Weeks 8 and 24
Treatment-related adverse events include adverse events caused by electroacupuncture or sham electroacupuncture treatment.
Weeks 8 and 24
Incidence of serious adverse event
Time Frame: Weeks 8 and 24
Serious adverse events refer to adverse events that require hospitalization or an extended hospital stay, result in disability, pose a threat to life, or cause death.
Weeks 8 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangxi University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JXUCM-ACU-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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