An interventional study of Electroacupuncture and Sham electroacupuncture in Lumbar Disc Herniation and Radiculopathy Lumbar, sponsored by Jiangxi University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by Jiangxi University of Traditional Chinese Medicine · Not applicable, Interventional, and Other
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.
474 studies on the registry are indexed under Intervertebral Disc Displacement; 100 are open to participants now.
This study's planned enrollment of 170 is above the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →Jiangxi University of Traditional Chinese Medicine is the lead sponsor of 15 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Electroacupuncture
Other: Sham 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.
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.
Proportion of responders
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.
Time frame: Weeks 8 and 24
Intensity of low back pain
Changes from baseline in the intensity of low back pain assessed by the Numerical Rating Scale
Time frame: Weeks 2, 4, 8, 16, and 24
Intensity of leg pain
Changes from baseline in intensity of leg pain assessed by the Numerical Rating Scale
Time frame: Weeks 2, 4, 8, 16, and 24
Level of disability
Changes from baseline in the level of disability assessed by the Roland-Morris Disability Questionnaire
Time frame: Weeks 2, 4, 8, 16, and 24
Performance status
Changes from baseline in functional status assessed by the Japanese Orthopaedic Association Score
Time frame: Weeks 2, 4, 8, 16, and 24
Severity of depression
Changes from baseline in the severity of depression assessed by the Hamilton Depression Rating Scale
Time frame: Weeks 2, 4, 8, 16, and 24
Severity of anxiety
Changes from baseline in the severity of anxiety assessed by the Hamilton Anxiety Rating Scale
Time frame: Weeks 2, 4, 8, 16, and 24
Sleep quality
Changes from baseline in sleep quality assessed by the Insomnia Severity Index
Time frame: Weeks 2, 4, 8, 16, and 24
Pain self-efficacy
Changes from baseline in pain self-efficacy assessed by the Pain self-efficacy questionnaire
Time frame: Weeks 2, 4, 8, 16, and 24
Use of analgesics
The proportion of patients who used analgesics for emergency.
Time frame: Weeks 8 and 24
Incidence of lumbar spine surgery
The incidence of lumbar spine surgery during the follow-up
Time frame: Weeks 8 and 24
Incidence of any adverse events
Adverse events be reported by patients and determined by clinicians.
Time frame: Weeks 8 and 24
Incidence of treatment-related adverse events
Treatment-related adverse events include adverse events caused by electroacupuncture or sham electroacupuncture treatment.
Time frame: Weeks 8 and 24
Incidence of serious adverse event
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.
Time frame: Weeks 8 and 24
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2024; primary completion for Oct 2025, 12 months later.
Of 178 non-industry interventional studies with no phase under Intervertebral Disc Displacement, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 12 months is close to that.
Counting every sponsor, half of 191 studies reached it within 12 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Displacement →
Jiangxi University of Traditional Chinese Medicine