Knee Osteoarthritis
Conditions
Keywords
Sham acupuncture, Randomized controlled trial, Blinding effect, Placebo acupuncture
Brief summary
This study aims to conduct a randomized controlled trial to investigate the difference in clinical efficacy and blinding effect between real acupuncture and various sham acupuncture techniques.
Detailed description
This study aimed to recruit 150 patients with knee osteoarthritis from the hospital outpatient department. Random coding was generated using a computer network-based random system, and the subjects will be divided into five groups: real acupuncture, non-acupuncture at real-acupoint, shallow acupuncture at real-acupoint, shallow acupuncture at non-meridian and non-acupoint, and waiting treatment group in a 1:1:1:1 ratio. Acupuncture sessions were conducted three times a week for two weeks. Patients in the waiting treatment group did not receive acupuncture therapy during the study period but received acupuncture treatment after the trial. Outcome measures included Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) score, Visual Analogue Pain (VAS) score, Massachusetts General Hospital Acupuncture Sensation Scale (MASS) needle sensation score, and blind evaluation scale. Data collection occurred at baseline, one week, and two weeks.
Interventions
OTHERReal Acupuncture
Patients received 6 sessions of acupuncture (three sessions per week or every other day) for two consecutive weeks
OTHERNon-acupuncture at real-acupoint
The acupuncture simulation device will be used to perform acupuncture at the same acupoints as those of the real acupuncture group.
OTHERShallow acupuncture at real-acupoint
At the same acupoint in the acupuncture group, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied
OTHERShallow acupuncture at non-meridian and non-acupoint
At non-meridian and non-acupoint, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of knee osteoarthritis. * Age over 40 years old.
Exclusion criteria
* Tuberculosis, tumors, rheumatism of the knee joint, and rheumatoid arthritis. * Sprain or trauma in the lower limb. * Mental disorders. * Severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease. * Pregnancy or lactation. * Use of physiotherapy for osteoarthritis knee pain in the past month; use of intra-articular injection of glucocorticoid or viscosupplementation in the past 6 months; received knee-replacement surgery; and positive floating patella test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) | 2 week | The WOMAC, a disease-specific scale with high reliability and validity, has been translated into different languages and used widely in clinical trials for KOA. The Chinese version of WOMAC contains 24 items that measure pain (5 items, scored 0-50), stiffness (2 items, scored 0-20) and physical function (17 items, scored 0-170), with a total score ranging from 0 to 240 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale (VAS) | 2 week | The Visual Analogue Scale (VAS) measures pain on a scale of 0 to 10, with a higher score indicating more severe symptoms. |
| Blind Assessment Scale | 2 week | The patients in the real acupuncture and sham acupuncture groups will be asked, Do you think you are receiving real acupuncture treatment? The patients' response options were yes, no, and not sure. |
| Massachusetts General Hospital Acupuncture Sensation Scale (MASS) | 2 week | The scale consists of 13 items and measures the body sensation experienced during acupuncture, including sensations such as acid, numbness, distension, pain, and heat. Each of the 13 entries utilizes a Visual Analogue Scale (VAS) with a range from 0cm (indicating no needle sensation) to 10cm (representing strong to unbearable needle sensation). |
Countries
China
Contacts
Primary ContactXin Sun, Doctor
Backup ContactJiali Liu, Doctor
Outcome results
None listed