BACKGROUND: There is some evidence for the effectiveness of moxibustion for the treatment of lumbar disc herniation (LDH), but it remains unclear what dose is optimal. OBJECTIVE: To compare the effectiveness of a new technique of individualised 'sensitivity elimination' dose versus a standardised 15 min dose in the treatment of LDH. METHODS: This study was a multicentre (four centres in China), randomised, controlled trial with two parallel arms (group A, individualised sensitivity elimination dose; group B, standardised dose). The most heat-sensitised acupuncture point from the triangle bound by BL25 and GV2 was selected. Both groups received 18 sessions over 2 weeks. The outcome was evaluated by Modified Japanese Orthopaedic Association scale (M-JOA) score before and after treatment and at 6-month follow-up examination. All main analyses were by intention to treat. RESULTS:A total of 96 patients were included. A significant difference of total M-JOA score was noted between the groups at weeks 1 and 2 (p<0.05). Significant differences were also evident during the follow-up period (p<0.01). The mean duration of moxibustion was 42.7±5.4 (range, 22-58) minutes in the experimental group. CONCLUSIONS: The effectiveness of the individualised sensitivity elimination dose appears superior to the standardised dose in the treatment of LDH. Only 15 min moxibustion in the conventional dose group seemed insufficient to elicit the satisfactory clinical effects obtained by heat-sensitive moxibustion therapy. However, in view of some limitations of this study further research is necessary before this can be stated conclusively. TRIAL REGISTRATION: Controlled Clinical Trials: ChiCTR-TRC-09000602.
RCT Entities:
BACKGROUND: There is some evidence for the effectiveness of moxibustion for the treatment of lumbar disc herniation (LDH), but it remains unclear what dose is optimal. OBJECTIVE: To compare the effectiveness of a new technique of individualised 'sensitivity elimination' dose versus a standardised 15 min dose in the treatment of LDH. METHODS: This study was a multicentre (four centres in China), randomised, controlled trial with two parallel arms (group A, individualised sensitivity elimination dose; group B, standardised dose). The most heat-sensitised acupuncture point from the triangle bound by BL25 and GV2 was selected. Both groups received 18 sessions over 2 weeks. The outcome was evaluated by Modified Japanese Orthopaedic Association scale (M-JOA) score before and after treatment and at 6-month follow-up examination. All main analyses were by intention to treat. RESULTS: A total of 96 patients were included. A significant difference of total M-JOA score was noted between the groups at weeks 1 and 2 (p<0.05). Significant differences were also evident during the follow-up period (p<0.01). The mean duration of moxibustion was 42.7±5.4 (range, 22-58) minutes in the experimental group. CONCLUSIONS: The effectiveness of the individualised sensitivity elimination dose appears superior to the standardised dose in the treatment of LDH. Only 15 min moxibustion in the conventional dose group seemed insufficient to elicit the satisfactory clinical effects obtained by heat-sensitive moxibustion therapy. However, in view of some limitations of this study further research is necessary before this can be stated conclusively. TRIAL REGISTRATION: Controlled Clinical Trials: ChiCTR-TRC-09000602.