Acupuncture Therapy for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

— ATKOA ?  

Official title:

Efficacy of Acupuncture Therapy Versus Sham Acupuncture on Knee Osteoarthritis: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03366363
• Other study ID #: 2017BL-077-01
• Status: Not yet recruiting
• Phase: N/A
• First received: November 20, 2017
• Last updated: December 3, 2017
• Start date: December 15, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: December 2017
• Source: Beijing Hospital of Traditional Chinese Medicine
• Contact: Cun-Zhi Liu
• Phone: 0086-10-52176043
• Email: lcz623780[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: June 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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 ? or ?

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• acupuncture
acupuncture is a therapy of traditional Chinese medicine,in which acupuncturist puncture the patient's skin at specific acupoints with needle.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijin	Beijing
China	Beijing Hospital of Traditional Chinese and Western Medicine	Beijing	Beijing
China	Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University	Beijing	Beijing
China	Dongfang Hospital Affiliated to Beijing University of Chinese Medicine	Beijing	Beijing
China	Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine	Beijing	Beijing
China	Guang'an Men Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing
China	Hospital of acupuncture-Moxibustion, China Academy of Chinese Medical Sciences	Beijing	Beijing
China	Affiliated Hospital of Hebei University of Chinese Medicine	Hebei	Hebei
China	First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Hospital of Traditional Chinese Medicine	Beijing science and technology commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	the percentage of patients with improvement in average pain (numerical rating scale, NRS) at least 2 units and in Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC) function subscale score at least 6 units at 8 weeks. Pain NRS was a self-administered instrument, a number selected from 0-10 by participant. Intensity of pain range (over past week): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain. 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.	8 weeks
Secondary	Response rate	the percentage of patients with improvement in average pain (numerical rating scale, NRS) at least 2 units and in Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC) function subscale score at least 6 units at 16 and 26 weeks. Pain NRS was a self-administered instrument, a number selected from 0-10 by participant. Intensity of pain range (over past week): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain. 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.	16 weeks, 26 weeks
Secondary	Knee-joint pain	using numerical rating scale (NRS). NRS was a self-administered instrument, a number selected from 0-10 by participant. Intensity of pain range (over past week): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain.	baseline, 8 weeks, 16 weeks and 26 weeks
Secondary	Knee-joint pain	using WOMAC pain subscale. The WOMAC pain subscale referred to the patient's pain. It was comprised of 5 items, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst pain condition. An overall score range of 0 (minimum) to 20 (maximum), with higher scores indicating worse physical function.	baseline, 8 weeks, 16 weeks and 26 weeks
Secondary	Knee-joint function	using WOMAC function subscale. 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.	baseline, 8 weeks, 16 weeks and 26 weeks
Secondary	Knee-joint stiffness	using WOMAC stiffness subscale. The WOMAC stiffness subscale was comprised of 2 questions regarding the degree of stiffness experienced in the study knee. The WOMAC stiffness subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse stiffness. An overall score range of 0 (minimum) to 8 (maximum), with higher scores indicating more stiffness.	baseline, 8 weeks, 16 weeks and 26 weeks
Secondary	Quality of life	using 12-Item Short Form Health Survey. An overall score range of 0 (minimum) to 100(maximum), with higher scores indicating better quality of life.	baseline, 8 weeks, 16 weeks and 26 weeks
Secondary	Credibility score	using Credibility/expectancy questionnaire	1 week(after the first treatment)
Secondary	Expectancy score	using Credibility/expectancy questionnaire	1 week(after the first treatment)
Secondary	Blinding assessment	Blinding assessment will be performed in all 9 centers	4 weeks and 8 weeks
Secondary	Global effect	Overall Treatment Effect (extremely improved, slightly improved, not changed, slightly aggravated, extremely aggravated)	8 weeks, 16 weeks and 26 weeks
Secondary	Adverse events	Adverse Event Form	first treatment up to 8 weeks