Efficacy of Electro-acupuncture Versus Manual Acupuncture on Knee Osteoarthritis

Osteoarthritis Of Knee Clinical Trial

Official title:

Efficacy of Electro-acupuncture Versus Manual Acupuncture for Knee Osteoarthritis: a Randomized Controlled Pilot Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03274713
• Other study ID #: 2017BL-020-01
• Status: Not yet recruiting
• Phase: N/A
• First received: August 30, 2017
• Last updated: September 5, 2017
• Start date: September 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: September 2017
• Source: Beijing Hospital of Traditional Chinese Medicine
• Contact: Cunzhi Liu, M.D
• Phone: 010-52176043
• 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 often occurs in middle-aged people, especially women. 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.According to the papers published in the past years, we find that acupuncture therapy for the treatment of knee osteoarthritis include manual acupuncture, electro-acupuncture, acupotomy, laser acupuncture, fire needle and so on, among which manual acupuncture and electro-acupuncture are most commonly used.The aim of this study is to compare the effectiveness of electro-acupuncture and manual acupuncture in reducing pain and improving function in patients with KOA.

Description:

Participants will be randomly allocated to one of two groups. Those in the first group receive electro-acupuncture, which involves having needles inserted into acupuncture points (locations on the body affected by acupuncture) which are stimulated manually for 10 seconds to create "De Qi" sensation and an electrical apparatus (HANS-200A acupoint nerve stimulator, Nanjing Jisheng Medical Co., Ltd. production, wave of 2/100Hz) was then connected to the needles with alligator clips to stimulate the needles in pairs ST36-SP9/GB34 and ST34-SP10. The stimulus intensity will be increased until the patient reported a strong but comfortable intensity. Those in the second 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. Both groups will receive 30-minute, 24 sessions intervention over eight weeks. Moreover, a number of questionnaires at the start of the study and then again after 4, 8, 12 and 16 week will be completed by participants.

It is expected that participants will benefit from a decrease in pain and improved function. The risks of participation are minimal. Occasionally, acupuncture can make people feel nauseous or experience a temporary increase in pain either during or after treatment. Rare side effects during acupuncture treatment include fainting, infection and subcutaneous hematoma (pooling of blood under the skin). Participants will be warned of these potential side-effects before consenting to have acupuncture.

Participants will be allowed, or required, to withdraw from the trial based on the following:

1. A major protocol violation;

2. Development of a serious disease preventing continuation in the trial;

3. Adverse events related to acupuncture;

4. Request to be withdrawn from the trial. The purpose is to accumulate clinical data, obtain the outcome data of the intervention method and prove the feasibility of the study protocol. Sixty patients will be selected as the sample size according to clinical experience.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 28, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 45-75 years old, male or female

• Single / bilateral knee pain, duration of more than 6 months

• KL (Kellgren-Lawrence) grade ? or ?

• VAS = 40mm

• Signed informed consent

Exclusion Criteria:

• Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy)

• History of arthroscopy within 1 year or intra-articular injection within 4 months

• Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.)

• Severe acute/chronic organic or mental diseases

• Coagulation disorders (such as hemophilia, etc.)

• Pregnant women, pregnant and lactating women

• History of receiving acupuncture or massage treatment within one month

• Participation in another clinical study in the past 3 months

• With a cardiac pacemaker, metal allergy or needle phobia

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Of Knee
• Osteoarthritis, Knee

Intervention

Device:
• Electro-acupuncture
Patients in this group will be treated by use of 6-7 local acupuncture points (ST34, ST35, ST36, EX-LE2, EX-LE5, GB33, GB34, SP9, SP10, LR7, LR8 and Ashi) and 2-3 distal points (GB31, GB36, GB39, GB41, ST40, ST41, LR3, BL60, SP6 and KI3). Needles will be stimulated manually for 10 seconds to achieve "De Qi" sensation and an electrical apparatus (HANS-200A acupoint nerve stimulator, Nanjing Jisheng Medical Co., Ltd. production, wave of 2/100Hz) will be then connected to the needles with alligator clips to stimulate the needles in pairs ST36-SP9/GB34 and ST34-SP10. The stimulus intensity will be increased until the patient reports a strong but comfortable intensity.
• Manual acupuncture
Participants in the 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.

Locations

Country	Name	City	State
China	Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
zhouping	Beijing Friendship Hospital, Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate	a change of 50% from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness and function scores at 8 weeks.	baseline, 8 weeks
Secondary	Pain	using WOMAC pain subscale	baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Secondary	Stiffness	using WOMAC stiffness subscale	baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Secondary	Knee-joint function	using WOMAC functional subscale	baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Secondary	Quality of life	using the 12-Item Short Form Health Survey (SF-12)	baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Secondary	Number of emergency analgesics (Celebrex/Loxonin) used	using Drug Use Form	baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Secondary	Inflammatory markers	Luminex liquid chip method (LuminexxMAP, Technology, USA) Bio-plex200 system high throughput analysis platform (Bio-Rad) will be used to detect the expression of free protein in serum. Patients will receive fasting blood samples in the morning and then be centrifuged with 3000r/min, 15min in two hours.	baseline, 8 weeks
Secondary	Credibility/expectancy questionnaires	Credibility/expectancy questionnaires are used to assess the credibility and expectancy of the patients	baseline
Secondary	Adverse events	using Adverse Event Form	up to 16 weeks