Different Kinds of Acupuncture Treatment for Knee Osteoarthritis

Zhejiang Chinese Medical University

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Other: treatment3; Other: treatment2; Other: treatment5; Other: treatment1; Drug: Celebrex; Other: treatment4

Study type: Interventional

Funder types: Other

Identifiers

NCT03563690

2018ZY008-KOA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meet the Clinical Classification Criteria for Osteoarthritis of the Knee, diagnosed by specialist.
2. Aged 40-75 years old;
3. History of chronic knee pain for more than 3 months, and complain of knee pain on most days of the past month;
4. Kellgren and Lawrence Grades 1-3;
5. With related knee pain in one or both knees rated > 4 cm on a 10 cm Visual Analog Scale(VAS) (VAS:0 to 10)
6. Who volunteer to participate and sign the consent form .

Exclusion criteria

1. Knee osteoarthritis patients with gout, infection, tumor, autoimmune diseases, trauma or other causes of knee pain or knee deformities;
2. Patients who have local skin damage, poor skin conditions or coagulant dysfunction and patients who are not suitable for acupuncture;
3. Patients who are accompanied with serious medical problems or mental disorders, cognitive dysfunction，disorders of shallow sensation or who cannot cooperate with the treatment;
4. Patients who have received acupuncture or needle knife in the past month;
5. Other patients who are not suitable for acupuncture treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 6 patient groups

Acupuncture group

Experimental group

Description:

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.

Treatment:

Other: treatment1

Electro-acupuncture group

Experimental group

Description:

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.

Treatment:

Other: treatment2

Moxibustion group

Experimental group

Description:

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.

Treatment:

Other: treatment3

Warm-needling group

Experimental group

Description:

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.

Treatment:

Other: treatment4

Sham-needle group

Sham Comparator group

Description:

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.

Treatment:

Other: treatment5

Celebrex group

Active Comparator group

Description:

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.

Treatment:

Drug: Celebrex