Different Kinds of Acupuncture Treatment for Knee Osteoarthritis：a Multicentre Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- treatment1
- Conditions
- Knee Osteoarthritis
- Sponsor
- Zhejiang Chinese Medical University
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Visual Analog Score change
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Knee osteoarthritis (KOA) a chronic disease with symptoms of persistent pain or rest pain , joint stiffness, numbness, limitation of activity and even disability, with significant associated costs and effects on individuals' life quality. Acupuncture as an approach for the management of chronic pain, is receiving increasing recognition from both the public and professionals. The aim of this study is to indicate the effects of three commonly used acupuncture treatments for KOA.
Detailed Description
360 subjects with KOA recruited from six centers will be randomized to six groups ,and receive four-week acupuncture, Electro-acupuncture, Moxibustion ,Warm-needling ,sham-needle, celebrex treatment. The primary outcomes are Visual Analogue Scale (VAS) and WOMAC function score.The Secondary outcomes are WOMAC pain score, WOMAC stiffness score,the Physical Activity Scale of the Elderly (PASE),knee joint swelling measurement and WHO-BREF life quality scale.The follow-up period is six months. This study will be a rigorous,randomized, sham and drug controlled trial focusing on using different kinds of acupuncture treatment for treating KOA.
Investigators
Jianqiao Fang
President
Zhejiang Chinese Medical University
Eligibility Criteria
Inclusion Criteria
- •Meet the Clinical Classification Criteria for Osteoarthritis of the Knee, diagnosed by specialist.
- •Aged 40-75 years old;
- •History of chronic knee pain for more than 3 months, and complain of knee pain on most days of the past month;
- •Kellgren and Lawrence Grades 1-3;
- •With related knee pain in one or both knees rated \> 4 cm on a 10 cm Visual Analog Scale(VAS) (VAS:0 to 10)
- •Who volunteer to participate and sign the consent form .
Exclusion Criteria
- •Knee osteoarthritis patients with gout, infection, tumor, autoimmune diseases, trauma or other causes of knee pain or knee deformities;
- •Patients who have local skin damage, poor skin conditions or coagulant dysfunction and patients who are not suitable for acupuncture;
- •Patients who are accompanied with serious medical problems or mental disorders, cognitive dysfunction，disorders of shallow sensation or who cannot cooperate with the treatment;
- •Patients who have received acupuncture or needle knife in the past month;
- •Other patients who are not suitable for acupuncture treatment.
Arms & Interventions
Acupuncture group
When recruited from six centers,the participant will be randomized to six groups .In acupuncture group participant will receive four-week acupuncture treatment(three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months.
Intervention: treatment1
Electro-acupuncture group
When recruited from six centers,the participant will be randomized to six groups. In this group participant receive four-week electro-acupuncture treatment(three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months.
Intervention: treatment2
Moxibustion group
When recruited from six centers,the participant will be randomized to six groups. In this group participant receive four-week moxibustion treatment (three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months.
Intervention: treatment3
Warm-needling group
When recruited from six centers,the participant will be randomized to six groups. In this group participant receive four-week warm-needling treatment (three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months.
Intervention: treatment4
Sham-needle group
When recruited from six centers,the participant will be randomized to six groups.In this group participant receive four-week sham acupuncture treatment (three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months.
Intervention: treatment5
Celebrex group
When recruited from six centers,the participant will be randomized to six groups . In this group participant will receive Celebrex (Celebrex, Capsules, Pfizer Pharmaceuticals Ltd)treatment, which will be applied 1 time daily(one time oral 0.2g) for 4 weeks. The follow-up period is six months.
Intervention: Celebrex
Outcomes
Primary Outcomes
Visual Analog Score change
Time Frame: baseline,2 weeks, 4 weeks ,3 months,6months
Intensity of pain range (lately 3 days' average): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain.
WOMAC function change
Time Frame: baseline,2 weeks,4 weeks ,3 months,6months
The WOMAC function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.
Secondary Outcomes
- PASE change(baseline,2 weeks,4 weeks ,3 months,6months)
- WOMAC pain change(baseline,2 weeks,4weeks ,3 months,6months)
- Quality of life change(baseline,2 weeks,4 weeks ,3 months,6months)
- Expectancy questionnaires(baseline)
- WOMAC stiffness change(baseline,2 weeks,4 weeks ,3 months,6months)
- Knee swelling measurement change(baseline,2 weeks, 4 weeks ,3 months,6months)