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Efficacy and safety of blade needle combined with lower limb exercise in the treatment of knee osteoarthritis : a randomized controlled trial protocol

Clinical study on the treatment of knee osteoarthritisby blade needle combined with lower limb exercise based on the concept of " paying equal attention to treatment and maintenance "

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087242
Enrollment
Unknown
Registered
2024-07-23
Start date
2024-08-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis

Interventions

Test group:Blade needle combined with lower limb exercises treatment
Control group:Blade needle therapy

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine , Guangdong, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: ( 1 ) In line with the clinical diagnostic criteria of knee osteoarthritis ( using the diagnostic criteria proposed by the Chinese Medical Association in 2023 ) : 1 Repeated knee pain in the past 1 month ; 2 age = 50 years old ; 3 morning stiffness time = 30 min ; 4 bone friction sound ( sense ) during activity ; 5 X-ray film ( standing or weight-bearing position ) showed joint space narrowing, subchondral bone sclerosis and / or cystic degeneration, and osteophyte formation at the joint margin ; mRI showed cartilage injury, osteophyte formation, subchondral bone marrow edema and ( or ) cystic degeneration, meniscus degenerative tear, partial or full-thickness cartilage loss. Meet the diagnostic criteria 1 + 2 + 3 + 4 or 1 + 5 or 1 + 6, can be diagnosed. (2) Have repeated pain in the past month, with mild to moderate pain intensity (NRS of 1-6 points); (3) Age ranges from 40 to 75 years old, with unilateral knee involvement, regardless of gender; (4) Have good tolerance to scalpel-needle therapy, able to actively cooperate, and have good compliance; (5) Voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with knee joint lesions caused by metabolic, infectious, and congenital reasons, such as gouty arthritis and rheumatic arthritis; (2) Patients with severe underlying diseases, such as cardiopulmonary insufficiency, tumors, hematologic diseases, diabetes, or peripheral neuropathy; (3) Patients with knee joint trauma, fractures, surgical history, or local skin ulcers, masses, damage, or infection; (4) Patients with a severe bleeding tendency, including those currently using anticoagulants; (5) Patients with a history of needle fear or needle syncope, or those unable to tolerate needle knife therapy due to old age, physical weakness, mental stress, hunger, fatigue, or other reasons; (6) Patients who have received other forms of treatment for this condition within 2 weeks, such as hormone closure or oral analgesic drugs, or those who participated in other clinical trials that may affect the results of this study; (7) Patients with poor compliance, inability to cooperate, inability to comply with the requirements of the trial, or unwillingness to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Western Ontario and McMaster Universities Osteoarthritis Index Score;

Secondary

MeasureTime frame
Numerical pain assessment scale;Quality of Life Rating Scale ( SF-12 );

Countries

China

Contacts

Public ContactLin Qiang

Guangdong Provincial Hospital of Traditional Chinese Medicine , Guangdong, China

qiang_lin@163.com+86 135 6039 3808

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026