Efficacy and Mechanism of Acupuncture on Patients with Chronic Sciatica
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0003267
- Lead Sponsor
- Kyung Hee University Oriental Medicine Hospital at Gangdong
- Brief Summary
Seventy-six patients aged 19-70 years with chronic sciatica (100 mm visual analog scale (VAS) for bothersomeness of sciatica = 40mm) were recruited and screened. Sixty-eight participants were randomly assigned to receive manual acupuncture plus electroacupuncture (n = 34), or acupuncture without electrical stimulation (n = 34). All participants received treatment twice a week for four weeks. The primary outcome measure was the VAS for bothersomeness at the end of eight treatments. The secondary outcomes included the VAS for pain intensity, VAS response rate, Oswestry Disability Index, EuroQol 5-Dimension, Coping Strategy Questionnaire, Beck’s Depression Inventory, and State-Trait Anxiety Inventory. Forty patients (20 from each group) had functional magnetic resonance imaging at baseline and at the end of the treatment. Blood-oxygenation-level-dependent signal changes for electrical bothersomeness plus negative emotional stimulation in each group before and after treatment were investigated. In a randomized patient-assessor blinded, sham-controlled clinical trial, sixty-six patients completed the study. Although the improvements in VAS bothersomeness in the real acupuncture group were greater than in the sham control group at the primary end-point, the difference did not reach statistical significance. The response rate of VAS bothersomeness at the primary end-point in the real acupuncture group (60.87%) was significantly higher than in the sham acupuncture group (39.13%) (P = 0.0210). A total of 34 brain magnetic resonance imaging scans (17 subjects from each group) were acquired for the neurophysiological analysis. Significant signal decreases were observed in the inferior frontal gyrus (IFG), the ventromedial prefrontal cortex (vmPFC), the anterior cingulate cortex (ACC), and the fusiform gyrus in the treatment group after eight sessions of treatment compared to before treatment. In the sham control group post-treatment, significant signal increases were seen in the angular gyrus, the posterior cingulate cortex, and the precuneus, while signal decreases were seen in the IFG, vmPFC, and ACC compared to pre-treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 68
1.Participants from 19 to 70 years of age
2.Participants with clinical diagnosis of chronic sciatica (pain lasting three months or more)
3.Participants with a bothersomeness score on the VAS = 40 mm
4.Participants who have voluntarily agreed to participate in the study and have signed written informed consent.
1.Participants previously having spinal surgery during the last six months
2.Participants previously or currently diagnosed with specific severe diseases resulting in sciatica (e.g. malignant tumor, spinal infection, inflammatory spondylitis)
3.Participants with progressive neurological deficit or severe neurological signs
4.Participants currently having other chronic diseases that could disturb the effect of treatments and the results of the study, including cardiovascular diseases, autoimmune diseases, renal diseases, diabetic neuropathy, dementia, epilepsy
5.Participants for whom acupuncture/ EA may potentially be inadequate or unsafe (e.g. hemorrhagic diseases, medication of anticoagulant, serious diabetes mellitus vulnerable to infections, serious cardiovascular diseases/ pacemaker, metal materials interior of the body)
6.Participants who are currently pregnant or planning to become pregnant
7.Participants with a history of severe mental illness
8.Participants currently participating other clinical trials
9.Participants previously or currently receiving acupuncture or EA treatment for sciatica or taking medicines that might affect pain symptoms (e.g. corticosteroids, narcotics, NSAIDs) or considered to be inadequate by the investigators during the last week (but they could be included only after going through two weeks of wash out period)
10.Participants having difficulty writing the informed consent
11.Participants for whom MRI scanning may potentially be inadequate or unsafe (e.g. claustrophobia, metal materials interior of the body)
12.Other reasons for exclusion in this trial, including unwillingness to comply with the study protocol or inability to complete the study-related questionnaires by themselves or with assistance, as assessed by researchers
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS for bothersomeness
- Secondary Outcome Measures
Name Time Method VAS for pain intensity;Oswestry Disability Index, ODI;euroQol 5-Dimension (EQ-5D);Coping Strategy Questionnaire (CSQ);Beck Depression Inventory (BDI);State-Trait Anxiety Inventory (STAI);functional Magnetic Resonance Imaging (fMRI);adverse events