Placebo Response of Different Types of Sham Acupuncture for Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Real Acupuncture, Non-acupuncture at real-acupoint, Shallow acupuncture at real-acupoint, Shallow acupuncture at non-meridian and non-acupoint.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Real Acupuncture
Patients received 6 sessions of acupuncture (three sessions per week or every other day) for two consecutive weeks - Other Non-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. - Other Shallow 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 - Other Shallow 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
Primary outcome measures
- Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) [Time frame: 2 week]
Secondary outcome measures (3)
- Visual analogue scale (VAS) [Time frame: 2 week]
- Blind Assessment Scale [Time frame: 2 week]
- Massachusetts General Hospital Acupuncture Sensation Scale (MASS) [Time frame: 2 week]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine — Nanchang
- Affiliated Hospital of Chengdu University of Traditional Chinese Medicine — Chengdu
Identifiers
NCT: NCT06675981 · 82305045 · 82305045