Can acupuncture affect cytokine levels in multiple sclerosis?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2020
INTERVENTION: Participants are randomized into three groups: an intervention group receiving real acupuncture, a control group receiving sham acupuncture, and a second control group receiving no acupuncture. A simple randomization approach is used in which participants are assigned a random number between 0 and 1 using the Microsoft Excel RAND function. They are then placed in order from lowest to highest number and finally divided into groups in that order. The acupuncture treatments are performed by two practitioners with university degrees in TCM as well as in Western medicine and the sessions take place in the clinics of the two acupuncturists. Each patient from the two treatment groups (real acupuncture and sham treatment) receive a total of six treatments over a period of 4 weeks: two treatments in each of the first 2 weeks and one treatment in each of the following 2 weeks. A standardized TCM treatment using ten acupuncture points has been developed to specifically target inflammation levels. The chosen acupuncture points are GV20, CV6, BL23 (bilateral), LI4 (bilateral) ST36 (bilateral), and SP6 (bilateral). These ten points are used in each treatment session in both treatment groups. Needles will be removed after 40 minutes, except for BL23 which will be removed after 20 minutes. Streitberger Placebo needles will be used for the sham treatment. In addition to the standard treatment, the acupuncturists can place additional needles to target specific symptoms reported by the participant. Any additional needles are removed after 20 minutes. CONDITION: Multiple sclerosis ; Nervous System Diseases ; Multiple sclerosis PRIMARY OUTCOME: Cytokine plasma levels (IFN?, IL‐1ß, IL‐6, IL‐8, IL‐12p70, IL‐13, TNFa, IL‐10, IL‐4, IL‐2 and IL‐17A) measured using the Mesoscale Multi‐spot Assay System on blood samples taken at baseline, the day after the 4th treatment, the day after the final treatment, and at 4 weeks following the final treatment SECONDARY OUTCOME: Health‐related quality of life (HRQoL) measured using the MS‐specific Functional Assessment of Multiple Sclerosis (FAMS) instrument at baseline, after 4 weeks (following the last treatment), and at 4 weeks after the final treatment INCLUSION CRITERIA: 1. Aged 18 years or older 2. Diagnosed with relapsing‐remitting multiple sclerosis for a minimum of 2 years 3. Must be able to walk unassisted (equivalent to an EDSS of 6.5) 4. Must have been relapse‐free for the past 3 months 5. If treated with disease‐modifying medicine, treatment must have been unchanged for the past 3 months
Epistemonikos ID: fc0b7db2533e0700d3e90c4231d534dfca7582d9
First added on: Aug 24, 2024