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Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial.
Trials. 2018 Mar 05; 19(1):159.T

Abstract

BACKGROUND

Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care.

METHODS

This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of "ashi", if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements.

DISCUSSION

This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT03287570 . Registered on 19 September 2017.

Authors+Show Affiliations

Department of Acupuncture & Moxibustion, Dongguk University Ilsan Oriental Hospital, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea.College of Korean Medicine, Dongguk University, Dongdae-ro, Gyeongju-si, Gyeongsangbuk-do, Republic of Korea.College of Korean Medicine, Dongguk University, Dongdae-ro, Gyeongju-si, Gyeongsangbuk-do, Republic of Korea.Department of Acupuncture & Moxibustion, Dongguk University Ilsan Oriental Hospital, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea.Department of Acupuncture & Moxibustion, Dongguk University Ilsan Oriental Hospital, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea.Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea. hanijjung@naver.com.

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

29506572

Citation

Kang, Ha-Ra, et al. "Efficacy and Safety of Electrical Moxibustion for Knee Osteoarthritis: Study Protocol for a Randomized Controlled Trial." Trials, vol. 19, no. 1, 2018, p. 159.
Kang HR, Jung CY, Lee SD, et al. Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial. Trials. 2018;19(1):159.
Kang, H. R., Jung, C. Y., Lee, S. D., Kim, K. H., Kim, K. S., & Kim, E. J. (2018). Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial. Trials, 19(1), 159. https://doi.org/10.1186/s13063-018-2514-x
Kang HR, et al. Efficacy and Safety of Electrical Moxibustion for Knee Osteoarthritis: Study Protocol for a Randomized Controlled Trial. Trials. 2018 Mar 5;19(1):159. PubMed PMID: 29506572.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial. AU - Kang,Ha-Ra, AU - Jung,Chan-Yung, AU - Lee,Seung-Deok, AU - Kim,Kyung-Ho, AU - Kim,Kap-Sung, AU - Kim,Eun-Jung, Y1 - 2018/03/05/ PY - 2017/11/27/received PY - 2018/02/01/accepted PY - 2018/3/7/entrez PY - 2018/3/7/pubmed PY - 2019/3/15/medline KW - Electrical moxibustion KW - Knee osteoarthritis KW - Moxibustion KW - Randomized controlled trial SP - 159 EP - 159 JF - Trials JO - Trials VL - 19 IS - 1 N2 - BACKGROUND: Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. METHODS: This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of "ashi", if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. DISCUSSION: This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03287570 . Registered on 19 September 2017. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/29506572/Efficacy_and_safety_of_electrical_moxibustion_for_knee_osteoarthritis:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2514-x DB - PRIME DP - Unbound Medicine ER -