Clinical Study of Acupuncture Treatment of Knee Osteoarthritis

NCT06805188 | Recruiting DMC

• 1 other identifier: JZFYLL20250103002
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The main question of this study was to evaluate the efficacy and safety of acupuncture in the treatment of knee osteoarthritis (KOA) through a single-blind, randomized controlled trial divided into two groups. Patients in both groups received a total of 24 acupuncture treatments over an 8-week period. The differences in knee NRS score, WOMAC index, walking test, mental health assessment and other indicators between the acupuncture group and the sham acupuncture group before and after treatment were compared to provide high-quality evidence to support the effectiveness of acupuncture in treating KOA.

Conditions

Osteoarthritis of the Knees; Osteoarthritis (OA) of the Knee; Osteoarthritis

Keywords

Randomized controlled trial; Osteoarthritis of the knee; Acupuncture

Outcome Measures

Primary Outcomes (1)

• Numerical rating scale

  The NRS is a commonly used pain assessment tool〔42〕, especially for joint pain, such as knee pain. The scale consists of 11 numbers, ranging from 0 to 10, each representing a different level of pain, and the patient chooses the number that best represents his or her current level of pain according to his or her own pain perception.The NRS score is accurate and concise, and was once regarded as the gold standard for pain assessment by the American Pain Society.

  For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.

Secondary Outcomes (7)

• WOMAC index

  For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.

• 40m FPWT

  For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.

• RMDQ

  For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.

• Depressive condition

  For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.

• Anxious situation

  For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.

Study Arms (2)

Treatment group

EXPERIMENTAL

The intervention was performed by two licensed acupuncturists with at least 10 years of clinical experience who received two weeks of training in standardized intervention methods prior to the trial. Acupoints location refers to the WHO Standard Acupuncture Point Locations in the Western Pacific Region (WHO Standard)〔41〕.The acupuncture group will receive the following acupoints (Figure 3, Table 2): the affected side of Chize(LU5), Quchi (LI11), Dubi (ST35), Fengshi (GB31), and Xiyangguan (GB33).

Other: Acupuncture

Control group

PLACEBO COMPARATOR

The device's sham needling operation mimics real needling through appearance and tactile sensation, making it difficult for patients to distinguish, meeting the requirement of blinding and effectively controlling the patients' cognitive bias towards the type of intervention. Patients in the sham acupuncture group received this sham acupuncture intervention, which was designed to ensure that only the actual biological effects of acupuncture differed between the experimental group and the control group, and to exclude the psychological implication effects caused by the patients' expectation effects or the operation itself, so as to enhance the scientific validity and reliability of the research results.

Other: Sham acupuncture

Interventions

Acupuncture OTHER

The intervention was performed by two licensed acupuncturists with at least 10 years of clinical experience who received two weeks of training in standardized intervention methods prior to the trial. Acupoints location refers to the WHO Standard Acupuncture Point Locations in the Western Pacific Region (WHO Standard)〔41〕.The acupuncture group will receive the following acupoints (Figure 3, Table 2): the affected side of Chize(LU5), Quchi (LI11), Dubi (ST35), Fengshi (GB31), and Xiyangguan (GB33). Needling was performed with 0.30mm x 40mm disposable Huatuo brand sterile acupuncture needles.After the needles were inserted, needle manipulation was performed at all acupuncture points to achieve the sensations of soreness, numbness, distension, and heaviness.Each acupoint was manipulated for about 30 seconds, and the acupuncture treatment was performed for one 30-minute session.

Treatment group

Sham acupuncture OTHER

The device's sham needling operation mimics real needling through appearance and tactile sensation, making it difficult for patients to distinguish, meeting the requirement of blinding and effectively controlling the patients' cognitive bias towards the type of intervention. Patients in the sham acupuncture group received this sham acupuncture intervention, which was designed to ensure that only the actual biological effects of acupuncture differed between the experimental group and the control group, and to exclude the psychological implication effects caused by the patients' expectation effects or the operation itself, so as to enhance the scientific validity and reliability of the research results.

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-70 years old, regardless of gender
• meeting the diagnostic criteria of the American College of Rheumatology (ACR) of KOA
• patients with an NRS score of at least greater than 4 for knee pain, and the pain has lasted for at least 3 months
• diagnosed with osteoarthritis of the knee by magnetic resonance imaging (MRI) or x-ray in the last 3 years
• volunteering to participate in this trial and signing informed consent

You may not qualify if:

• Patients with a history of knee surgery
• Patients who had received any physical therapy related to osteoarthritis of the knee, such as corticosteroid injections, acupuncture, or moxibustion, within the past 3 months
• Patients who had a disease that could lead to pain in the knee, such as a fracture, a synovial cyst, or rheumatoid arthritis
• Patients who had a history of knee surgery. or any significant neurological injury
• Prior serious mental illness, organ failure, or malignancy
• Planned knee surgery within the next 3 months
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Wu zenan: lead
• The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, 330004, China

RECRUITING

Related Publications (1)

• Wu Z, Hu Z, Xu Z, Xiao T, Huang Q, Zhou X, Zhang H, Fu Y. Efficacy and Safety of Acupuncture at Sensitized Acupoints for Knee Osteoarthritis: Protocol for a Multicenter, Single-Blind Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 24;14:e77336. doi: 10.2196/77336.

  PMID: 40990366 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Wu zenan

CONTACT

13807004791; 2384516405@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outpatient physicians (X.T and X.Z.X) will perform the initial assessment of the patient, independently enter and collect patient information, and randomize assignment. Patients, outcome assessors and data analysts are not aware of the assignment. The treating physician (W.Z.N) will treat the grouped patients. The statistical analysis team will blind the subgroup assignment and the study. Unblinding will take place at the completion of the trial or at the occurrence of a serious adverse event.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: February 3, 2025
• Study Start: February 15, 2025
• Primary Completion: January 5, 2026
• Study Completion: January 5, 2026
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)