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The central mechanism of acupuncture for the patients with knee osteoarthritis: study protocol for a randomized controlled trial

Phase 1
Conditions
Knee osteoarthritis
Registration Number
ITMCTR2000003978
Lead Sponsor
The First Affiliated Hospital of Henan University of CM
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Male or female, aged 45–75 years;
2. Following the diagnostic criteria of knee osteoarthritis, and Right-handed;
3. Good compliance and willing to cooperate with the research;
4. Radiologic confirmation of knee osteoarthritis (Kellgren–Lawrence grade I-III);
5. The informed consent form was signed by the patient or by their immediate family members.

Exclusion Criteria

1. Complicated with other knee joint diseases, such as tuberculosis, tumor, rheumatism and rheumatoid arthritis; 2. Complicated with sprain, contusion or other trauma, foot deformity, pain and other diseases affecting normal walking;
3. Patients with severe cardiovascular disease, damage of liver and kidney function, immune deficiency, diabetes mellitus, and blood disease;
4. Severe drug and alcohol dependence, mania or schizophrenia;
5. Patients with obvious headache, migraine, dysmenorrhea and other chronic pain diseases, history of head trauma;
6. Be insensitive to pain due to advanced diabetes, neuropathy or use of strong painkillers;
7. have knee pain caused by radiculopathy/herniation of an intervertebral disc;
8. Have a history of prolotherapy, hyaluronic acid injections or corticosteroids injections within 3 months;
9. have received acupuncture, electro-acupuncture, Tui-na therapy, massage, or physiotherapy 8 weeks prior to enrolment in the trial;
10. Have MRI contraindications such as claustrophobia, cardiac pacemaker, defibrillator, heart stenting, or intrauterine device.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Western Ontario and McMaster University Osteoarthritis Index scores;
Secondary Outcome Measures
NameTimeMethod
Baker anxiety scale (BAI);The pain visual analogue scale (VAS);Baker Depression scale (BDI);Arthritis Quality of Life Measurement Scale Simplified Scale (AIMS2-SF);The Chinese version of the modified Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS)The Chinese version of the modified Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS);Knee Injury and Osteoarthritis Outcome Score, KOOS;
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