Placebo Response of Different Types of Sham Acupuncture for Knee Osteoarthritis

NCT06675981 | Not Yet Recruiting

• 1 other identifier: 82305045
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Osteoarthritis

Keywords

Sham acupuncture; Randomized controlled trial; Blinding effect; Placebo acupuncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Visual analogue scale (VAS)

  2 week

• Blind Assessment Scale

  2 week

• Massachusetts General Hospital Acupuncture Sensation Scale (MASS)

  2 week

Study Arms (5)

Real Acupuncture

EXPERIMENTAL

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

Non-acupuncture at real-acupoint

SHAM COMPARATOR

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

Shallow acupuncture at real-acupoint

SHAM COMPARATOR

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

Shallow acupuncture at non-meridian and non-acupoint

SHAM COMPARATOR

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

Waiting-list group

NO INTERVENTION

No acupuncture treatment will be given during the study period.

Interventions

Real Acupuncture OTHER

Patients received 6 sessions of acupuncture (three sessions per week or every other day) for two consecutive weeks

Real Acupuncture

Non-acupuncture at real-acupoint OTHER

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

Non-acupuncture at real-acupoint

Shallow acupuncture at real-acupoint OTHER

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

Shallow acupuncture at real-acupoint

Shallow acupuncture at non-meridian and non-acupoint OTHER

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

Shallow acupuncture at non-meridian and non-acupoint

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of knee osteoarthritis.
• Age over 40 years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (2)

Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, 330000, China

Location

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Xin Sun, Doctor

  West China Hospital

  STUDY CHAIR

Central Study Contacts

Xin Sun, Doctor

CONTACT

18980606047; sunx79@hotmail.com

Jiali Liu, Doctor

CONTACT

18200231130; liujiali@wchscu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: November 10, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)