Effectiveness of acupuncture in osteoarthritis
- Conditions
- Knee Osteoarthritis.Osteoarthritis of knee
- Registration Number
- IRCT20170305032893N3
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
Patients diagnosed with knee OA based on ACR criteria (ACR=American college of Rheumatology )( OA=Osteoarthritis )
Age should be between 45 and 65 years old
Only one knee is involved
Have a VAS pain score of four or more than four.(VAS=visual Analogue scale )
Be literate (writing and reading ability)
The surgery has been detailed or is in the process of surgery
Knee arthroscopy has been done during the last year
Have an intra-articular injection during the last six months
Any disease that disrupts the functioning of the immune system, such as inflammatory diseases, autoimmune diseases, connective tissue diseases, diabetes, cancer, etc.
Severe physical or cognitive illness of the participant that prevents the continuation of cooperation
Have a pacemaker
Pregnancy and breastfeeding
Have done acupuncture during the last six months
Coagulation disorders and the use of anticoagulants
Participation of the candidate in other clinical studies currently or during the last three months
Getting infected with covid during the study or ... in the last month or other infectious diseases during the struggle .
BMI more than 30 (BMI =body mass index )
Any forced changes in treatment regimen
Non-cooperation in applying intervention for more than two sessions
If the joint has liquid effusion (joint effusion)
Life-threatening medical and clinical events
Extreme fear of needles( Belonephebia)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome 1) changes in the level of pain based on the VAS scale before the intervention and weeks 8, 12, and 16.--- . 2) Measuring the amount of inflammatory factors: including IFN-? (gama interferon )secreted by T-helper1 cells, IL-4 ( interleukin-4 ) secreted by T-helper-2 cells. -- and TGF-ß ( transforming growth factor beta ) and IL10 ( interleukin 10 )secreted by regulatory T cells (T REG CELLS), and TNFa (tumor necrosis factor alpha )secreted by M1 macrophages before and after treatment at the end of weeks 8 . Timepoint: 0-8-12-16 weeks. Method of measurement: Based on numerical scale of vas and based on laboratory numerical values.
- Secondary Outcome Measures
Name Time Method Changes in the level of physical activity. Timepoint: Before intervention and weeks 8, 12 and 16. Method of measurement: WOMAC Scale( Western Ontario McMaster Universities Osteoarthritis Index).;Changes in morning stiffness. Timepoint: Before intervention and weeks 8, 12 and 16. Method of measurement: WOMAC Scale.;Changes in quality of life. Timepoint: Before intervention and weeks 8, 12 and 16. Method of measurement: Based on the quality of life form (QoL ).