Clinical Study of Acupuncture Treatment of Knee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWu zenan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged 18-70 years old, regardless of gender
meeting the diagnostic criteria of the American College of Rheumatology (ACR) of KOA
patients with an NRS score of at least greater than 4 for knee pain, and the pain has lasted for at least 3 months
diagnosed with osteoarthritis of the knee by magnetic resonance imaging (MRI) or x-ray in the last 3 years
Disqualifiers
Patients with a history of knee surgery
Patients who had received any physical therapy related to osteoarthritis of the knee, such as corticosteroid injections, acupuncture, or moxibustion, within the past 3 months
Patients who had a disease that could lead to pain in the knee, such as a fracture, a synovial cyst, or rheumatoid arthritis
Patients who had a history of knee surgery. or any significant neurological injury
Trial design
Design model
Single group
Treatments tested in this trial
Acupuncture
Other interventionThe intervention was performed by two licensed acupuncturists with at least 10 years of clinical experience who received two weeks of training in standardized intervention methods prior to the trial. Acupoints location refers to the WHO Standard Acupuncture Point Locations in the Western Pacific Region (WHO Standard)〔41〕.The acupuncture group will receive the following acupoints (Figure 3, Table 2): the affected side of Chize(LU5), Quchi (LI11), Dubi (ST35), Fengshi (GB31), and Xiyangguan (GB33). Needling was performed with 0.30mm x 40mm disposable Huatuo brand sterile acupuncture needles.After the needles were inserted, needle manipulation was performed at all acupuncture points to achieve the sensations of soreness, numbness, distension, and heaviness.Each acupoint was manipulated for about 30 seconds, and the acupuncture treatment was performed for one 30-minute session.
Sham acupuncture
Other interventionThe device's sham needling operation mimics real needling through appearance and tactile sensation, making it difficult for patients to distinguish, meeting the requirement of blinding and effectively controlling the patients' cognitive bias towards the type of intervention. Patients in the sham acupuncture group received this sham acupuncture intervention, which was designed to ensure that only the actual biological effects of acupuncture differed between the experimental group and the control group, and to exclude the psychological implication effects caused by the patients' expectation effects or the operation itself, so as to enhance the scientific validity and reliability of the research results.
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: Treatment groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Numerical rating scale
The NRS is a commonly used pain assessment tool〔42〕, especially for joint pain, such as knee pain. The scale consists of 11 numbers, ranging from 0 to 10, each representing a different level of pain, and the patient chooses the number that best represents his or her current level of pain according to his or her own pain perception.The NRS score is accurate and concise, and was once regarded as the gold standard for pain assessment by the American Pain Society.
Time frame
For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.Secondary outcomes
1
WOMAC index
According to the 2020 guidelines for the diagnosis and treatment of osteoarthritis of the knee, four types of indexes are recommended to reflect symptoms and signs, quality of life, structural changes in the joints, and long-term regression. Among them, WOMAC is often chosen as the main outcome index of osteoarthritis index based on the study period, which mainly includes five parts: pain, symptoms, ability to perform activities of daily living, motor function, and quality of life, and the scores can be divided into three grades, and the higher WOMAC index indicates the more serious KOA.
Time frame
For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.2
40m FPWT
The 40m FPWT for the knee is a test that evaluates knee function, lower extremity muscle strength and walking ability〔44〕. The tester uses a stopwatch or timer to accurately record the total time it takes the subject to complete a 40-meter walk. The shorter the time, the better the subject's knee function, lower limb muscle strength and walking ability.
Time frame
For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.3
RMDQ
The RMDQ is a questionnaire used to assess functional impairment due to low back pain. The scale consists of 24 items with scores ranging from 0-24, with higher scores indicating more significant functional impairme
Time frame
For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.4
Depressive condition
Clinically significant depressive symptoms were assessed using the HAMD-17.The HAMD-17 consists of 17 entries, with higher scores indicating more severe depression.
Time frame
For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.Sponsors and contacts
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Wu zenan
Lead sponsor
Jiangxi University of Traditional Chinese Medicine
Sponsor institution
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Collaborator
Source ClinicalTrials.gov