Wu Zenan
Wu Zenan
The main question of this study was to evaluate the efficacy and safety of acupuncture in the treatment of knee osteoarthritis (KOA) through a single-blind, randomized controlled trial divided into two groups. Patients in both groups received a total of 24 acupuncture treatments over an 8-week period. The differences in knee NRS score, WOMAC index, walking test, mental health assessment and other indicators between the acupuncture group and the sham acupuncture group before and after treatment were compared to provide high-quality evidence to support the effectiveness of acupuncture in treating KOA.
Osteoarthritis of the Knees
Osteoarthritis (OA) of the Knee
Osteoarthritis
Acupuncture
Sham acupuncture
NA
Knee osteoarthritis (KOA) is a common clinical bone and joint disease.There is a lack of effective specific treatment for KOA.Acupuncture is increasingly being studied for the treatment of KOA, but its efficacy and safety are still controversial.This study aims to provide high-quality evidence by evaluating the results of studies on acupuncture for KOA. A single-blind, randomized controlled trial design was used in this study, in which the generation and preservation of the randomized sequence was done by an independent follow-up researcher through R software. The random allocation method used was block group randomization to ensure a balanced allocation. At the same time, opaque sealed envelopes containing grouping information were prepared to ensure that the grouping process was concealed. The principle of blinding was strictly implemented throughout the study, and the outcome evaluator was blinded until the end of the trial, when participants remained unknown about their grouping information. The study population consisted of 350 patients with KOA who met the inclusion and exclusion criteria. These patients were randomized in a 1:1 ratio into the following 2 groups:(1) Acupuncture Group (AG) (2) False Acupuncture Group (FAG).Patients in both groups received a total of 24 acupuncture treatments over an 8-week period. The sham acupuncture group utilized a Takakura acupuncture simulation device to mimic acupuncture, where the needles would not penetrate the skin, and the duration of needle retention, treatment points, frequency of treatments, duration of treatment, and follow-up period were kept the same as that of the real acupuncture group. The primary outcome index was the Numerical rating scale (NRS), and secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC),40m Fast-Paced Walking Test(40m FPWT), Roland-Morris Disability Questionnaire (RMDQ), Hamilton Depression Rating Scale (HAMD-17), Hamilton Anxiety Rating Scale (HAMA), Insomnia Severity Index (ISI), Pain self-efficacy questionnaire (PSEQ). Any adverse events during treatment will be recorded.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 350 participants |
| Masking : | DOUBLE |
| Masking Description : | Outpatient physicians (X.T and X.Z.X) will perform the initial assessment of the patient, independently enter and collect patient information, and randomize assignment. Patients, outcome assessors and data analysts are not aware of the assignment. The treating physician (W.Z.N) will treat the grouped patients. The statistical analysis team will blind the subgroup assignment and the study. Unblinding will take place at the completion of the trial or at the occurrence of a serious adverse event. |
| Primary Purpose : | TREATMENT |
| Official Title : | Efficacy and Safety of Acupuncture in the Treatment of Osteoarthritis of the Knee: Study Protocol for a Randomized Controlled Trial |
| Actual Study Start Date : | 2025-02-15 |
| Estimated Primary Completion Date : | 2026-01-05 |
| Estimated Study Completion Date : | 2026-01-05 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 70 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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RECRUITING
Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, China, 330004