A Pilot Trial of Acupuncture for Knee Osteoarthritis With Differential Functional Status of Acupoints

NCT03008668 | Completed

• 1 other identifier: 201681590955
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators plan to undertake a rigorous multicentre randomised controlled trial, comparing acupuncture on sensitized acupoints with low/non-sensitive points or no acupuncture (waiting-list), to test if acupuncture on sensitized acupoints may result in improved treatment outcomes in patients with Knee osteoarthritis (KOA).The current pilot study aimed to assess the feasibility of performing the definitive randomised controlled trial.

Conditions

Acupuncture; Knee Osteoarthritis; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks

  It consists of 24 items assessing the knee osteoarthritis patients pain, stiffness, and physical function. Each of the 24 items will be graded on a visual analog scale ranging from 0 to 10, with higher scores reflecting more pain, stiffness and poorer physical function

  Assessments will be conducted at baseline and 16 weeks after randomization

Secondary Outcomes (1)

• The change of Short Form (SF)-12 health survey score from baseline to 16 weeks

  Assessments will be conducted at baseline and 16 weeks after randomization

Other Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Assessments will be conducted at 4 weeks after the acupuncture treatment and followed at 8, 12 and 16 weeks

Study Arms (2)

experimental group: Acupuncture

EXPERIMENTAL

acupuncture on 5 most sensitized points/ acupoints

Other: acupuncture

Control group: Acupuncture

ACTIVE COMPARATOR

acupuncture on 5 least low/non-sensitized points

Other: acupuncture

Interventions

acupuncture OTHER

a stimulation of the body or auricular points

Control group: Acupuncture; experimental group: Acupuncture

Eligibility Criteria

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

You may qualify if:

• Eligible patients are those aged 40 years or older who are diagnosed with KOA and have signed the informed consent.
• The diagnosis of KOA will follow the diagnostic criteria according to the Chinese Guidelines for the Medical Management of Osteoarthritis:
• refractory knee pain for most days in the last month;
• joint space narrowing, sclerosis or cystic change in subchondral bone (as indicated by X-ray);
• laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and white blood cell count \< 2000/mm3;
• age 40 years or older;
• morning stiffness continues less than 30 minutes;
• bone sound exists when joints was taking flexion and/or extension. A person is confirmed to be diagnosed with KOA if meeting the either of the three criteria set: (1 and 2), or (1,3 and 5), or (1,4,5 and 6).

You may not qualify if:

• Patients will be excluded if they:
• Can not adhere to the study protocol in the future 6 months;
• Are diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of knee/bone joint, rheumatoid arthritis;
• Have sprain or other trauma;
• Are unable to walk properly due to foot deformity or pain;
• Are present with mental disorders;
• Have comorbidities including severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus or blood disorder;
• Females who are pregnant or lactating;
• Were using physiotherapy treatments for osteoarthritis knee pain;
• Had used intra-articular injection of glucocorticoid or viscosupplementation in the past 6 months;
• Received knee-replacement surgery;
• Were participating or had participated in the other clinical trials.

Sponsors & Collaborators

• West China Hospital: lead

Related Publications (1)

• Jia P, Liu J, Li L, Luo Y, Li Y, Zhao L, Liang F, Liu Z, Zou K, Tang L, Sun X. Acupuncture for knee osteoarthritis with sensitized acupoints: results from a pilot, feasibility randomized controlled trial. Pilot Feasibility Stud. 2020 Sep 28;6:144. doi: 10.1186/s40814-020-00687-x. eCollection 2020.

  PMID: 33005432 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

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

Study Record Dates

• First Submitted: December 26, 2016
• First Posted: January 2, 2017
• Study Start: October 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: July 19, 2018

Record last verified: 2018-07