Ma’s bamboo-based medicinal moxibustion therapy of low back pain in lumbar disc herniation: study protocol for a randomized controlled trial
Abstract Background Lumbar disc herniation (LDH) is a common and frequently occurring disease in clinics. Low back pain and sciatica are the presenting symptoms of LDH. To some extent, it can be considered that measures with the capability to improve low back pain or sciatica have the potential to t...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-05-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-022-06382-x |
| _version_ | 1811324512891830272 |
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| author | Xian-zhu Wang Kai-yang Xue Ping-nan Chen Cai-hong Xiao Jin Cui Jing Fu |
| author_facet | Xian-zhu Wang Kai-yang Xue Ping-nan Chen Cai-hong Xiao Jin Cui Jing Fu |
| author_sort | Xian-zhu Wang |
| collection | DOAJ |
| description | Abstract Background Lumbar disc herniation (LDH) is a common and frequently occurring disease in clinics. Low back pain and sciatica are the presenting symptoms of LDH. To some extent, it can be considered that measures with the capability to improve low back pain or sciatica have the potential to treat LDH. Ma’s bamboo-based medicinal moxibustion therapy can effectively reduce the degree of low back pain and has been widely used. Studies of small sample size have seen significant improvement on pain relief. The aim of this trial is to evaluate the clinical efficacy and safety of Ma’s bamboo-based medicinal moxibustion therapy in the treatment of LDH low back pain. Methods/design The trial is a multicenter, randomized, parallel-group, non-inferiority study. Three hundred and twelve patients will be randomly assigned to a Ma’s bamboo-based medicinal moxibustion group (n=156) and an acupuncture group (n=156). Patients in each group will receive treatment every day, 6 times a week, 12 times in total. Follow-up will be conducted 14 days after treatment. The primary outcome will be the visual analog scale(VAS) at baseline, after 6 times of treatment, end of treatment, and follow-up. The secondary outcomes will include Oswestry disability indexes (ODI), modified Japanese Orthopaedic Association low back pain (M-JOA) score, serum β-endorphin (β-EP), and serum substance P (SP). β-EP and SP, as well as safety evaluation indexes (routine blood, liver, and kidney function and electrocardiogram), will be measure at baseline and after the end of treatment. The number, nature, and severity of adverse events will be recorded. Discussion The results of the trial will compare the efficacy of low back pain in LDH between Ma’s bamboo-based medicinal moxibustion group and the acupuncture group and will be expected to make a systematic and objective evaluation of the clinical efficacy and safety of Ma’s bamboo-based medicinal moxibustion therapy. Trial registration ChiCTR2000038725 . Registered on 29 September 2020. |
| first_indexed | 2024-04-13T14:15:41Z |
| format | Article |
| id | doaj.art-aef638f3d0fe4ddda1217103dffa37ff |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T14:15:41Z |
| publishDate | 2022-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-aef638f3d0fe4ddda1217103dffa37ff2022-12-22T02:43:39ZengBMCTrials1745-62152022-05-0123111310.1186/s13063-022-06382-xMa’s bamboo-based medicinal moxibustion therapy of low back pain in lumbar disc herniation: study protocol for a randomized controlled trialXian-zhu Wang0Kai-yang Xue1Ping-nan Chen2Cai-hong Xiao3Jin Cui4Jing Fu5Guizhou University of Traditional Chinese MedicineGuizhou University of Traditional Chinese MedicineFirst Affiliated Hospital of Guizhou University of Traditional Chinese MedicineFirst Affiliated Hospital of Guizhou University of Traditional Chinese MedicineGuizhou University of Traditional Chinese MedicineGuizhou University of Traditional Chinese MedicineAbstract Background Lumbar disc herniation (LDH) is a common and frequently occurring disease in clinics. Low back pain and sciatica are the presenting symptoms of LDH. To some extent, it can be considered that measures with the capability to improve low back pain or sciatica have the potential to treat LDH. Ma’s bamboo-based medicinal moxibustion therapy can effectively reduce the degree of low back pain and has been widely used. Studies of small sample size have seen significant improvement on pain relief. The aim of this trial is to evaluate the clinical efficacy and safety of Ma’s bamboo-based medicinal moxibustion therapy in the treatment of LDH low back pain. Methods/design The trial is a multicenter, randomized, parallel-group, non-inferiority study. Three hundred and twelve patients will be randomly assigned to a Ma’s bamboo-based medicinal moxibustion group (n=156) and an acupuncture group (n=156). Patients in each group will receive treatment every day, 6 times a week, 12 times in total. Follow-up will be conducted 14 days after treatment. The primary outcome will be the visual analog scale(VAS) at baseline, after 6 times of treatment, end of treatment, and follow-up. The secondary outcomes will include Oswestry disability indexes (ODI), modified Japanese Orthopaedic Association low back pain (M-JOA) score, serum β-endorphin (β-EP), and serum substance P (SP). β-EP and SP, as well as safety evaluation indexes (routine blood, liver, and kidney function and electrocardiogram), will be measure at baseline and after the end of treatment. The number, nature, and severity of adverse events will be recorded. Discussion The results of the trial will compare the efficacy of low back pain in LDH between Ma’s bamboo-based medicinal moxibustion group and the acupuncture group and will be expected to make a systematic and objective evaluation of the clinical efficacy and safety of Ma’s bamboo-based medicinal moxibustion therapy. Trial registration ChiCTR2000038725 . Registered on 29 September 2020.https://doi.org/10.1186/s13063-022-06382-xLDHLow back painMa’s bamboo-based medicinal moxibustion therapyAcupunctureRandomized controlled trial |
| spellingShingle | Xian-zhu Wang Kai-yang Xue Ping-nan Chen Cai-hong Xiao Jin Cui Jing Fu Ma’s bamboo-based medicinal moxibustion therapy of low back pain in lumbar disc herniation: study protocol for a randomized controlled trial Trials LDH Low back pain Ma’s bamboo-based medicinal moxibustion therapy Acupuncture Randomized controlled trial |
| title | Ma’s bamboo-based medicinal moxibustion therapy of low back pain in lumbar disc herniation: study protocol for a randomized controlled trial |
| title_full | Ma’s bamboo-based medicinal moxibustion therapy of low back pain in lumbar disc herniation: study protocol for a randomized controlled trial |
| title_fullStr | Ma’s bamboo-based medicinal moxibustion therapy of low back pain in lumbar disc herniation: study protocol for a randomized controlled trial |
| title_full_unstemmed | Ma’s bamboo-based medicinal moxibustion therapy of low back pain in lumbar disc herniation: study protocol for a randomized controlled trial |
| title_short | Ma’s bamboo-based medicinal moxibustion therapy of low back pain in lumbar disc herniation: study protocol for a randomized controlled trial |
| title_sort | ma s bamboo based medicinal moxibustion therapy of low back pain in lumbar disc herniation study protocol for a randomized controlled trial |
| topic | LDH Low back pain Ma’s bamboo-based medicinal moxibustion therapy Acupuncture Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-022-06382-x |
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