Electro-acupuncture in Knee Osteoarthritis

NCT03359603 | Unknown DMC

• 1 other identifier: 2017BL-076-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis (KOA) is one of the most common musculoskeletal diseases in clinic. It usually occurs in middle-aged people, especially women. An estimated lifetime risk for KOA is approximately 40% in men and 47% in women. KOA is a chronic disease which can lead to obvious pain, joint stiffness, limitation of activity and even disability, with significant associated costs and effects on society, health systems, and individuals. The use of acupuncture as an approach for the management of chronic pain, is receiving increasing recognition from both the public and professionals. However, there are no universally accepted treatment frequency criteria in previous studies. The number of acupuncture treatments is no more than twice per week in most previous studies, while it is usually 3-5 sessions per week in clinical practice in China. The aim of this study is to compare the effects of different EA sessions (3 sessions per week versus once per week) in a pilot randomized controlled trial of KOA.

Conditions

Knee Osteoarthritis

Keywords

Electro-acupuncture; Knee osteoarthritis; Treatment frequency

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 8 weeks

Secondary Outcomes (8)

• Pain

  baseline, 8 weeks and 16 weeks

• Knee-joint function

  baseline, 8 weeks and 16 weeks

• Stiffness

  baseline, 8 weeks and 16 weeks

• Overall effect

  baseline, 8 weeks and 16 weeks

• Quality of life

  baseline, 8 weeks and 16 weeks

Study Arms (2)

Group A

EXPERIMENTAL

After recruiting, patients are assigned to the group by randomization,and then receive electro-acupuncture treatment. Patients in the group will receive EA 3 sessions per week for 8 weeks. The EA stimulation lasted for 30 minutes with a dilatational wave of 2/100 Hz and a current intensity depending on the patient's comfort level (preferably with skin around the acupoints shivering mildly without pain).

Device: Electro-acupuncture

Group B

EXPERIMENTAL

After recruiting, patients are assigned to the group by randomization,and then receive electro-acupuncture treatment. Patients in the group will receive EA once per week for 8 weeks. The EA stimulation lasted for 30 minutes with a dilatational wave of 2/100 Hz and a current intensity depending on the patient's comfort level (preferably with skin around the acupoints shivering mildly without pain).

Device: Electro-acupuncture

Interventions

Electro-acupuncture DEVICE

Patients will be treated by use of 5 obligatory and 3 customized acupoints. Obligatory points (ST35, EX-LE5, LR8, GB33 and Ashi) will be used in all patients. Other 3 customized acupoints should be chosen by the physicians on the basis of traditional Chinese medicine diagnosis for acupuncture channels related to the individual pain area, with the intent of optimizing efficacy. ST34, ST36, ST32, ST40 and EX-LE2 will be used for pain at stomach meridian. GB31, GB36, GB34, GB39 and GB41 will be used for pain at gallbladder meridian. BL39, BL40, BL57 and BL60 will be used for pain at bladder meridian. LR7, SP9, SP10, KI10, SP4, SP6, LR3 and KI3 will be used for pain at three yin meridians of foot. Needles will be stimulated manually for 10 seconds to achieve"De Qi". Paired alligator clips will be attached transversely to the needle holders at LR8-GB33 and two other customized acupoints. Other needles will be manipulated for 10 seconds during the treatments.

Group A; Group B

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45-75 years old, male or female;
• Single / bilateral knee pain, duration of more than 6 months;
• KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ in recent 6 months;
• NRS ≥ 40mm;
• Signed informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Ping Zhou: lead

Study Sites (1)

Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (1)

• Lin LL, Tu JF, Shao JK, Zou X, Wang TQ, Wang LQ, Yang JW, Sun N, Liu CZ. Acupuncture of different treatment frequency in knee osteoarthritis: a protocol for a pilot randomized clinical trial. Trials. 2019 Jul 11;20(1):423. doi: 10.1186/s13063-019-3528-8.

  PMID: 31296249 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Cun-Zhi Liu, MD

  Beijing Hospital of Traditional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Cun-Zhi Liu, MD

CONTACT

010-52176043; lcz623780@126.com

Lu-Lu Lin, Postgraduate Student

CONTACT

15628933890; linlulu365@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postgraduate

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: December 2, 2017
• Study Start: December 25, 2017
• Primary Completion: April 30, 2018
• Study Completion: June 30, 2018
• Last Updated: December 28, 2017

Record last verified: 2017-11

Locations

CN (1)