Sinew Acupuncture for Knee Osteoarthritis

Status Completed

Clinical Trial Summary

The study aims to exam whether sinew acupuncture can relieve pain and symptoms of KOA and improve functional movement by Visual Analog Scale (VAS), Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed up & Go Test (TUG) and 8-step Stair Climb Test (SCT) assessment, and Quality of life by Short Form-36 (SF-36). A randomized, sham acupuncture controlled, patient and assessor blinded, pilot study will be employed.

Clinical Trial Description

Objective:

The proposal aims to examine the efficacy and safety of sinew acupuncture for knee osteoarthritis (KOA).

Hypothesis to be tested:

Sinew acupuncture can reduce pain intensity, and improve knee function and health-related quality of life without significant side effects for KOA subjects compared to a sham acupuncture.

Design:

A randomized, subject- and assessor-blind, sham acupuncture-controlled clinical trial

Participants:

Subjects (N=86) will be randomized into sinew acupuncture or sham acupuncture group (in 1:1 ratio).

Study instrument:

Visual Analog Scale (VAS), Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed up & Go Test (TUG), 8-step Stair Climb Test (SCT) assessment, and the Short Form-36 (SF-36).

Intervention:

Sinew acupuncture group will receive 10 sessions of needling in 4 weeks. Sham group will receive the non-invasive intervention with the same procedures. All subjects are followed up for 6 weeks.

Main outcome measures:

VAS for knee pain intensity at week 4 serves as the primary outcome. VAS at other time points, WOMAC score, TUG, SCT and SF-36 will be analyzed as the secondary outcomes.

Data analysis:

Analysis will be on the 'intention to treat' principle. T-test and mixed-effect model analysis will be used to measure primary and secondary outcomes respectively.

Expected results:

Sinew acupuncture treatment can significantly reduce knee pain intensity, and improve knee function and quality of life without obvious side effects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03099317
Study type	Interventional
Source	The University of Hong Kong
Contact
Status	Completed
Phase	N/A
Start date	June 1, 2017
Completion date	September 30, 2018

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.