Jae-Hong Kim1,2, Chang-Su Na3, Gwang-Cheon Park4, Jeong-Soon Lee5. 1. Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, DongShin University, 185 Gunjae-ro, Naju City, 58245, Republic of Korea. nahonga@hanmail.net. 2. Clinical Research Center, DongShin University Gwangju Korean Medicine Hospital, 141 Wolsan-ro, Nam-gu, Gwangju City, 61619, Republic of Korea. nahonga@hanmail.net. 3. Department of Acupoint and Meridian, College of Korean Medicine, DongShin University, 185 Gunjae-ro, Naju City, 58245, Republic of Korea. 4. Clinical Research Center, DongShin University Gwangju Korean Medicine Hospital, 141 Wolsan-ro, Nam-gu, Gwangju City, 61619, Republic of Korea. 5. Department of Nursing, Christian College of Nursing, 6 Baekseo-ro 70 beon-gil, Nam-gu, Gwangju City, 61662, Republic of Korea.
Abstract
BACKGROUND:Chronic non-specific low back pain (CLBP) is a common musculoskeletal disorder for which patients seek complementary and alternative medical treatments, including laser acupuncture (LA). Invasive LA (ILA) involves the simultaneous application of invasive acupuncture treatment at acupoints and focused laser irradiation. The efficacy of ILA for CLBP remains controversial owing to the insufficient clinical trial data. We intend to obtain basic data regarding the efficacy and safety of ILA for CLBP by comparing the effects of different wavelengths of ILA on CLBP. METHODS: This will be a prospective, patient-blinded, parallel-arm, single-center (DongShin University Gwangju Korean Medicine Hospital, Republic of Korea), pilot randomized controlled clinical trial. Forty-five participants with CLBP will be randomized in equal numbers into the control, 650-nm ILA (650 ILA), or 830-nm ILA (830 ILA) group. The control group will receive sham ILA for 10 min and real electroacupuncture (EA) for 10 min. The 650 and 830 ILA groups will receive real ILA (i.e., 650 ILA group, 650-nm wavelength; 830 ILA group, 830-nm wavelength) for 10 min and real EA for 10 min once/day, twice a week for 4 weeks, at bilateral Shenshu (BL23), Qihaishu (BL24), Dachangshu (BL25), and Huantiao (GB30). The primary outcome will be an improvement in pain intensity assessed using the visual analog scale. Scores in the Korean version of the Oswestry Disability Index and the European Quality of Life Five Dimension Five Level scale will be recorded as secondary outcome measures. All scores will be recorded at baseline (before intervention), 4 weeks after the first intervention (at the end of the intervention), and 4 weeks after completion of the intervention. DISCUSSION: The study is expected to provide preliminary evidence regarding the efficacy, safety, and usefulness of ILA for the treatment of CLBP. TRIAL REGISTRATION: This trial was registered with the Clinical Research Information Service (registration No. KCT0004610 ; http://cris.nih.go.kr ). Registered on 7 January 2020.
RCT Entities:
BACKGROUND: Chronic non-specific low back pain (CLBP) is a common musculoskeletal disorder for which patients seek complementary and alternative medical treatments, including laser acupuncture (LA). Invasive LA (ILA) involves the simultaneous application of invasive acupuncture treatment at acupoints and focused laser irradiation. The efficacy of ILA for CLBP remains controversial owing to the insufficient clinical trial data. We intend to obtain basic data regarding the efficacy and safety of ILA for CLBP by comparing the effects of different wavelengths of ILA on CLBP. METHODS: This will be a prospective, patient-blinded, parallel-arm, single-center (DongShin University Gwangju Korean Medicine Hospital, Republic of Korea), pilot randomized controlled clinical trial. Forty-five participants with CLBP will be randomized in equal numbers into the control, 650-nm ILA (650 ILA), or 830-nm ILA (830 ILA) group. The control group will receive sham ILA for 10 min and real electroacupuncture (EA) for 10 min. The 650 and 830 ILA groups will receive real ILA (i.e., 650 ILA group, 650-nm wavelength; 830 ILA group, 830-nm wavelength) for 10 min and real EA for 10 min once/day, twice a week for 4 weeks, at bilateral Shenshu (BL23), Qihaishu (BL24), Dachangshu (BL25), and Huantiao (GB30). The primary outcome will be an improvement in pain intensity assessed using the visual analog scale. Scores in the Korean version of the Oswestry Disability Index and the European Quality of Life Five Dimension Five Level scale will be recorded as secondary outcome measures. All scores will be recorded at baseline (before intervention), 4 weeks after the first intervention (at the end of the intervention), and 4 weeks after completion of the intervention. DISCUSSION: The study is expected to provide preliminary evidence regarding the efficacy, safety, and usefulness of ILA for the treatment of CLBP. TRIAL REGISTRATION: This trial was registered with the Clinical Research Information Service (registration No. KCT0004610 ; http://cris.nih.go.kr ). Registered on 7 January 2020.
Entities:
Keywords:
Chronic non-specific low back pain; Laser acupuncture; Randomized controlled trial; Study protocol
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