Clinical trial NCT06675981: Placebo Response of Different Types of Sham Acupuncture for Knee Osteoarthritis
Official title: Placebo Response of Different Types of Sham Acupuncture for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Sham acupuncture
Randomized controlled trial
Blinding effect
Placebo acupuncture
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis index (WOMAC)
timeFrame: 2 week
Secondary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: 2 week
measure: Blind Assessment Scale
timeFrame: 2 week
measure: Massachusetts General Hospital Acupuncture Sensation Scale (MASS)
timeFrame: 2 week
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
state: Jiangxi
city: Chengdu
country: China
facility: Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Xin Sun, Doctor
role: STUDY_CHAIR
References: