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Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trial.
- Source :
-
Trials [Trials] 2017 Apr 24; Vol. 18 (1), pp. 188. Date of Electronic Publication: 2017 Apr 24. - Publication Year :
- 2017
-
Abstract
- Background: Conventional moxibustion is a representative non-drug intervention in traditional Chinese medicine, and it has been reported to produce encouraging results and benefits in relieving symptoms and improving the quality of life for patients with knee osteoarthritis (KOA) in previous clinical trials and systematic reviews. Given that increasing concerns on the safety of generated smoke from conventional moxibustion have received much attention, smoke-free moxibustion is regarded as a potential alternative. However, whether smoke-free moxibustion would display a similar efficacy to that of conventional moxibustion still remains unclear. Therefore, this randomized controlled trial attempts to investigate the difference of efficacy between conventional moxibustion and smoke-free moxibustion in patients with KOA.<br />Methods/design: This is a multicenter, randomized, single-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated to two groups (conventional moxibustion group and smoke-free moxibustion group) in seven hospitals in China. Participants will receive 12 sessions of moxibustion treatment at three acupoints (EX-LE4, ST35, and ST36) over a period of 4 weeks (3 sessions per week). A smoke-removing device is placed at the top of the moxibustion device for the smoke-free moxibustion group (nā=ā69), while the conventional moxibustion group (nā=ā69) is treated with traditional moxibustion. The primary outcome measure will be the change of the global scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from the baseline to 4 weeks. Secondary outcomes include the visual analog scale VASand Patient Global Assessment scores. Follow-up measurements will be performed on the 8th and 12th weeks after random allocation.<br />Discussion: This study will contribute to providing a solid foundation for the selection of moxibustion in clinical application as well as future research in moxibustion therapy.<br />Trial Registration: ClinicalTrials.gov, NCT02772055 . Registered on 12 May 2016.
- Subjects :
- Acupuncture Points
Adult
Aged
Biomechanical Phenomena
China
Clinical Protocols
Comparative Effectiveness Research
Disability Evaluation
Female
Humans
Male
Middle Aged
Moxibustion adverse effects
Osteoarthritis, Knee diagnosis
Osteoarthritis, Knee physiopathology
Recovery of Function
Research Design
Single-Blind Method
Time Factors
Treatment Outcome
Knee Joint physiopathology
Moxibustion methods
Osteoarthritis, Knee therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1745-6215
- Volume :
- 18
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 28438185
- Full Text :
- https://doi.org/10.1186/s13063-017-1846-2