Acupuncture Therapy for Knee Osteoarthritis (ATKOA Ⅱ)

Beijing Hospital of Traditional Chinese Medicine

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Other: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03366363

2017BL-077-01

Details and patient eligibility

About

Knee osteoarthritis (KOA), also called degenerative knee disease, is one of the most common bone and joint diseases in clinic. It was estimated to affect more than 9 million individuals in the United States in 2005 and is a leading cause of disability and medical costs. Most elderly people over the age of 65 have radiographic and/or clinical evidence of osteoarthritis. KOA is a lifelong disease which can lead to obvious pain, joint stiffness, limitation of activity and even joint failure or disability. Acupuncture is a popular treatment taken from ancient Chinese medicine, in which fine needles are placed into the body at specific points. Studies have shown that acupuncture can stimulate nerves under the skin, causing the body to produce natural pain-relieving substances (endorphins). However the evidences of acupuncture for KOA are contradictory. According to the review, intensive acupuncture with three sessions a week is more effective for KOA than sparse acupuncture with one session a week. Moreover, the papers published in the past years suggest that manual acupuncture and electro-acupuncture are most commonly used acupuncture therapy for the treatment of knee osteoarthritis. The aim of this study is to evaluate the efficacy of intensive electro-acupuncture or manual acupuncture versus sham acupuncture in reducing pain and improving function in patients with KOA.

Enrollment: 480 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 45-75 years old, male or female
2. Single / bilateral knee pain, duration of more than 6 months
3. KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ
4. NRS ≥ 4

Exclusion criteria

1. Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy)
2. Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, fracture, gout, lumbosacral vertebrae disease, etc.)
3. History of arthroscopy within 1 year or intra-articular injection within 4 months
4. History of receiving acupuncture or massage treatment within 3 months
5. Severe acute/chronic organic or mental diseases
6. Coagulation disorders (such as hemophilia, etc.)
7. Cardiac pacemaker, metal allergy or needle phobia
8. Pregnant women, pregnant and lactating women
9. Participation in another clinical study in the past 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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480 participants in 3 patient groups

Electro-acupuncture

Experimental group

Description:

5 compulsory acupoints (ST35、EX-LE5、LR8、GB33 and Ashi) and 3 optional matching acupoints (stomach meridian syndrome：ST34、ST36、ST32、ST40、EX-LE2；gallbladder meridian syndrome：GB31、GB36、GB34、GB39、GB41；bladder meridian syndrome：BL39、BL40、BL57、BL60；San Yin meridian syndrome：LR7、SP9、SP10、KI10、SP4、SP6、LR3、KI3) will be chosen. Needles will be stimulated manually to achieve "De Qi" sensation and an electrical apparatus (Nanjing Jisheng Medical Co., Ltd., wave of 2/100Hz) will be then connected to the needles with alligator clips in pairs LR8-GB33 and two other matching acupoints. The stimulus intensity will be increased until the patient reports a strong but comfortable intensity. Patients will receive 30-minute, 24 sessions intervention over eight weeks.

Treatment:

Other: acupuncture

manual acupuncture

Experimental group

Description:

Participants in the manual acupuncture group have the same schedule as the Electro-acupuncture group except that the electrical apparatus has working power indicator and sound without actual current output.

Treatment:

Other: acupuncture

sham acupuncture

Sham Comparator group

Description:

Those in the sham acupuncture group receive shallow acupuncture at non-acupoints without manipulation，Deqi or actual current output.

Treatment:

Other: acupuncture