Placebo Response of Different Types of Sham Acupuncture for Knee Osteoarthritis (PSAKOA)

Sichuan University

Status: Not yet enrolling

Conditions: Knee Osteoarthritis

Treatments: Other: Shallow acupuncture at real-acupoint; Other: Non-acupuncture at real-acupoint; Other: Real Acupuncture; Other: Shallow acupuncture at non-meridian and non-acupoint

Study type: Interventional

Funder types: Other

Identifiers

NCT06675981

82305045 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 5 patient groups

Real Acupuncture

Experimental group

Description:

Acupuncture at nine acupoints. Patients received 6 sessions of acupuncture (three sessions per week or every other day) for two consecutive weeks

Treatment:

Other: Real Acupuncture

Non-acupuncture at real-acupoint

Sham Comparator group

Description:

The acupuncture simulation device will be used to perform acupuncture at the same acupoints as those of the real acupuncture group.

Treatment:

Other: Non-acupuncture at real-acupoint

Shallow acupuncture at real-acupoint

Sham Comparator group

Description:

At the same acupoint in the acupuncture group, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied

Treatment:

Other: Shallow acupuncture at real-acupoint

Shallow acupuncture at non-meridian and non-acupoint

Sham Comparator group

Description:

At non-meridian and non-acupoint, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied

Treatment:

Other: Shallow acupuncture at non-meridian and non-acupoint

Waiting-list group

No Intervention group

Description:

No acupuncture treatment will be given during the study period.