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NCT Number: NCT06675981

Placebo Response of Different Types of Sham Acupuncture for Knee Osteoarthritis

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang, Jiangxi, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Real acupuncture

Other

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

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.

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 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

Primary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis index (WOMAC)

    Time frame: 2 week

    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

Secondary outcomes

  1. Visual analogue scale (VAS)

    Time frame: 2 week

    The Visual Analogue Scale (VAS) measures pain on a scale of 0 to 10, with a higher score indicating more severe symptoms.

  2. Blind Assessment Scale

    Time frame: 2 week

    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."

  3. Massachusetts General Hospital Acupuncture Sensation Scale (MASS)

    Time frame: 2 week

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jiali Liu, Doctor

CONTACT

[email protected]

18200231130

Xin Sun, Doctor

CONTACT

[email protected]

18980606047

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Acronym: PSAKOA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 6, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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