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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Real Acupuncture; Other: Non-acupuncture at real-acupoint; Other: Shallow acupuncture at real-acupoint; Other: Shallow acupuncture at non-meridian and non-acupoint

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xin Sun, Doctor; Phone Number: 18980606047; Email: sunx79@hotmail.com
• Study Contact Backup: Name: Jiali Liu, Doctor; Phone Number: 18200231130; Email: liujiali@wchscu.cn

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
      • Contact: Yaoguang Guo; Email: newguoo@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real Acupuncture; Acupuncture at nine acupoints. Patients received 6 sessions of acupuncture (three sessions per week or every other day) for two consecutive weeks	Other: Real Acupuncture; Patients received 6 sessions of acupuncture (three sessions per week or every other day) for two consecutive weeks
Sham Comparator: 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: 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.
Sham Comparator: 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 real-acupoint; At the same acupoint in the acupuncture group, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied
Sham Comparator: 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	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
No Intervention: Waiting-list group; No acupuncture treatment will be given during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities Osteoarthritis index (WOMAC)	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	2 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale (VAS)	The Visual Analogue Scale (VAS) measures pain on a scale of 0 to 10, with a higher score indicating more severe symptoms.	2 week
Blind Assessment Scale	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."	2 week
Massachusetts General Hospital Acupuncture Sensation Scale (MASS)	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).	2 week

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Study Chair: Xin Sun, Doctor, West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 10, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Sham acupuncture; Blinding effect; Placebo acupuncture
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 82305045 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be shared with other researchers with the agreement of the Coordinating Committee and the Ethics Committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No