Skip to content

A multicenter randomized controlled clinical trial of ultrasound-guided Acupotomy release combined with electroacupuncture in the treatment of knee osteoarthritis

A multicenter randomized controlled clinical trial of ultrasound-guided Acupotomy release combined with electroacupuncture in the treatment of knee osteoarthritis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002425
Enrollment
Unknown
Registered
2025-12-10
Start date
2025-05-13
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

knee osteoarthritis

Interventions

Combination Group:Ultrasound-guided acupotomy release combined with electroacupuncture therapy
Traditional Acupotomy Group:conventional acupotomy release

Sponsors

The Second Affiliated Hospital of Anhui University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Diagnostic Criteria: Western Medicine Diagnosis Standards: Based on the Guidelines for Diagnosis and Treatment of Osteoarthritis (2018 Edition) published in 2018: 1) Recurrent knee joint pain within the past month; 2) X-ray findings indicating narrowed joint space, subchondral sclerosis/cystic changes, or osteophyte formation around the joint; 3) Morning stiffness lasting =30 minutes; 4) Audible crepitus during movement. Diagnosis confirmed if criterion 1) + any one of criteria 2)–4) are met. Kellgren-Lawrence (K-L) Grading System: Grade 0: Normal joint space without osteophytes; Grade I: Mild joint space narrowing with possible osteophytes; Grade II: Suspected joint space narrowing with definite osteophytes; Grade III: Moderate joint space narrowing, subchondral sclerosis, and moderate osteophytes; Grade IV: Severe joint space narrowing, marked sclerosis, deformity, and large osteophytes. Traditional Chinese Medicine (TCM) Diagnosis Standards: Formulated according to the Clinical Guidelines for Acupotomy Treatment of Knee Osteoarthritis for "Cold-Damp Obstruction Syndrome": 1) Primary Symptoms: Severe joint pain worsened by cold exposure, relieved by warmth, and restricted range of motion; 2) Secondary Symptoms: Heavy sensation/pain in the lower back and body; 3) Tongue and Pulse: Pale tongue with white greasy coating; soggy and slow pulse. Inclusion Criteria: (1) Meeting the above diagnostic criteria; (2) Age 50–75 years; (3) Unilateral knee involvement; (4) K-L grade 0–III; (5) No medications affecting study outcomes taken in the past 2 weeks; (6) Informed consent obtained from all patients and their families.

Exclusion criteria

Exclusion criteria: (1) Patients with severe knee joint infections; (2) Patients with knee osteoarthritis caused by a history of knee trauma tuberculosis tumors or rheumatic immune diseases; (3) Patients with severe cardiovascular disease or significant impairment of liver/kidney function; (4) Patients with hematological disorders respiratory diseases endocrine disorders hematologic malignancies rheumatic immune diseases or severe psychiatric illnesses; (5) Patients exhibiting cognitive impairment or communication difficulties .

Design outcomes

Primary

MeasureTime frame
Western Ontario and Mcmaster Universities Osteoarthritis Index;Hip-Knee-Ankle;

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Score;Lysholm scores;Visual Analogue Scale;The Short-From-36 Health Survey;

Countries

China

Contacts

Public ContactLi Fei

The Second Affiliated Hospital of Anhui University of Chinese Medicine

316029622@qq.com19965510509

Outcome results

None listed

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