Effectiveness and safety of acupotomy for lumbar disc herniation: a study protocol for a randomized, assessor-blinded, controlled pilot trial

Abstract

BackgroundAcupotomy aims to reduce pressure on the nerve, improve surrounding blood circulation, and recover the kinetic state of soft tissue in treating lumbar disc herniation. Although several previous studies have suggested the potential use and substantial benefits of acupotomy, there is still insufficient evidence regarding this technique. This trial is designed to determine if acupotomy is more effective than manual acupuncture in improving low back pain and/or leg pain, disability, lumbar mobility, and quality of life in patients with herniated lumbar disc.MethodsFifty eligible patients will be randomly assigned to an acupotomy group or a manual acupuncture group in a 1:1 ratio. The experimental group will receive acupotomy at the affected side’s inner core muscles and soft tissue at the level of the herniated disc where tenderness appears (twice per week for 2 weeks). The control group will receive manual acupuncture (thrice per week for 2 weeks) at GV3 (Yaoyangguan) and the bilateral BL23 (Shenshu), BL24 (Qihaishu), BL25 (Dachangshu), and BL26 (guanyuanshu) for local points and the bilateral GB30 (Huantio), BL40 (Weizhong), and BL60 (Kunlun) for distant points. The primary outcome will be the mean change in the visual analog scale from baseline to 4 weeks (2 weeks after final treatment). The Oswestry Disability Index, Modified-Modified Schober Test, and EuroQol five dimensions questionnaire will determine secondary outcomes. Adverse events will be evaluated at every visit.DiscussionThis study will provide valuable data and insights for a confirmative, full-scale randomized controlled trial to determine the clinical effects of acupotomy.

Effectiveness and Safety of Acupotomy for Lumbar Disc Herniation: A Randomized, Assessor‐Blinded, Controlled Pilot Study

“…The study protocol has been previously published [ 18 ]. In summary, 50 participants with symptomatic LDH were recruited to this randomized, two parallel-armed, controlled, assessor-blinded, single center, pilot clinical trial.…”

The Effectiveness of Moxibustion for Treating of Lumbar Disc Herniation(LDH): A Protocol for Systematic Review and Meta-ananlysis

“…Based on what we know so far, we have found some limitations of this Protocol:(1)Most of the sites included in the study are in China; (2)The application of moxibustion in other countries and regions needs further study. (3)At the same time, the differences of moxibustion operation methods between different countries should also need be considered.…”

“…Lumbar disc herniation (LDH) is a clinically common degenerative spinal disease, which adversely affects patients' quality of life and work ability [1] .The clinical symptoms of the disease are localized low back pain or lower extremity radioactive neuralgia, which is distributed in a region corresponding to the dermal nodes of the associated nerve roots [2] ,LDH mainly affects 1-3% of the general population, and most of the patients are aged 30-50 years old. Meanwhile, the common lesion site of LDH is the lumbar disc between L4/L5 and L5/S1, which has become a common occupational health problem and brought severe test to the medical security system [3] .The treatment of LDH includes surgery and conservative modalities, nowadays, more and more attention has been paid to conservative treatment, One study showed that less than 2% of patients with low back pain receive LDH surgery [4] .…”

Acupotomy therapy for lumbar disc herniation

“…Lumbar disc herniation (LDH) is one of the most common degenerative spinal disorders in young and middle-aged patients. [ 1 ] LDH is highly prevalent among patients aged 30 to 50 years, and approximately 95% of lumbar disc herniations occur at the L4/L5 and L5/S1 levels. [ 2 ] The main symptoms of LDH include lower back pain, radiation pain on one side or in the lower extremities, weakening of muscle strength, and sensory disturbances.…”

“…[ 22 , 23 ] In the treatment of lumbar disc herniation, the role of acupotomy is to reduce nerve pressure, improve peripheral blood circulation, and restore the kinetic state of soft tissue. [ 1 , 24 ]…”