NCT06675981

Placebo Response of Different Types of Sham Acupuncture for Knee Osteoarthritis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-11-10
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2024-11-06
• Last updated: 2024-11-19

Locations

2 sites across 1 country: China