A randomised, single-blind, two-limbed, parallel-group study to compare the effectiveness of 'individualised traditional Korean acupuncture' with one of 'standardised acupuncture' in Korean patients with knee osteoarthritis
- Conditions
- Knee OsteoarthritisMusculoskeletal DiseasesArthritis
- Registration Number
- ISRCTN40706107
- Lead Sponsor
- Korea Institute of Oriental Medicine (South Korea)
- Brief Summary
2020 protocol in http://www.koreascience.or.kr/article/JAKO200618317168492.j (added 14/01/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1. At least 40 years old
2. Current symptoms of chronic (six months), stable pain and/or stiffness in one or both knees during weight-bearing activities
3. Knee pain due to OA rated more than 4 cm on a 10 cm Visual Analogue Scale (VAS) in one or both knees
4. Morning stiffness of knee for less than or equal to 30 minutes
5. Mild joint space narrowing (more than or equal to 2 mm remaining) in knee AnteroPosterior (AP) standing or Rosenberg view
1. Inflammatory, metabolic, or neuropathic arthropathies
2. Trauma or surgery to the knee(s) which is causing pain or functional problems within six months prior to the enrolment period
3. Suspicious meniscus injury by physical examination
4. Pain emanating more from back or hip than from knee, interfering with patient knee assessment
5. Any condition which severely limits local ambulation, such as amputation or stroke
6. History of or evidence of active rheumatologic disease, severe peripheral neuropathy, clinically evident cardiac or respiratory disease that interferes with functional status, or other serious diseases, including psychiatric disorders
7. Autoimmune disease, Systemic Lupus Erythematosus (SLE), psoriatic arthritis, active (redness, swelling, fever, etc.) gout or pseudo-gout within six months prior to screening
8. History of prolotherapy, or injection of hyaluronic acid or cortisone within the last three months
9. Inability to stop anti-inflammatory medication or Non Steroidal Anti-Inflammatory Drug (NSAID) such as acetaminophen for the entire study
10. Bleeding disorders that might contraindicate acupuncture
11. Pension or disability benefits
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain rating based on a 100 mm VAS
- Secondary Outcome Measures
Name Time Method <br> 1. Western Ontario MacMaster Questionnaire (WOMAC) Scale<br> 2. Quality of Life (Short Form health survey [SF-36])<br> 3. Lequesne Functional Index (LFI) score<br> 4. Physical function was evaluated by the Korean version of Health Assessment Questionnaire (KHAQ)<br>