Placebo Response of Different Types of Sham Acupuncture for Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-10

Study Completion Date

2025-04-01

Brief Summary

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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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Detailed Description

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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

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Real Acupuncture

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

Group Type EXPERIMENTAL

Real Acupuncture

Intervention Type OTHER

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

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.

Group Type SHAM_COMPARATOR

Non-acupuncture at real-acupoint

Intervention Type 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

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

Group Type SHAM_COMPARATOR

Shallow acupuncture at real-acupoint

Intervention Type 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

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

Group Type SHAM_COMPARATOR

Shallow acupuncture at non-meridian and non-acupoint

Intervention Type OTHER

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

Waiting-list group

No acupuncture treatment will be given during the study period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Real Acupuncture

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

Intervention Type 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.

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No