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Efficacy of Electro-acupuncture Versus Manual Acupuncture on Knee Osteoarthritis

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified September 2017 by zhouping, Beijing Hospital of Traditional Chinese Medicine
Sponsor:
Collaborators:
Beijing Friendship Hospital
Beijing Jishuitan Hospital
Information provided by (Responsible Party):
zhouping, Beijing Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT03274713
First received: August 30, 2017
Last updated: September 5, 2017
Last verified: September 2017
  Purpose
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.

Condition Intervention
Osteoarthritis Of Knee Device: Electro-acupuncture Device: Manual acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Electro-acupuncture Versus Manual Acupuncture for Knee Osteoarthritis: a Randomized Controlled Pilot Trial

Resource links provided by NLM:


Further study details as provided by zhouping, Beijing Hospital of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Success Rate [ Time Frame: baseline, 8 weeks ]
    a change of 50% from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness and function scores at 8 weeks.


Secondary Outcome Measures:
  • Pain [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks ]
    using WOMAC pain subscale

  • Stiffness [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks ]
    using WOMAC stiffness subscale

  • Knee-joint function [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks ]
    using WOMAC functional subscale

  • Quality of life [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks ]
    using the 12-Item Short Form Health Survey (SF-12)

  • Number of emergency analgesics (Celebrex/Loxonin) used [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks ]
    using Drug Use Form

  • Inflammatory markers [ Time Frame: baseline, 8 weeks ]
    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.

  • Credibility/expectancy questionnaires [ Time Frame: baseline ]
    Credibility/expectancy questionnaires are used to assess the credibility and expectancy of the patients

  • Adverse events [ Time Frame: up to 16 weeks ]
    using Adverse Event Form


Estimated Enrollment: 60
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: February 28, 2018
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electro-acupuncture group
After recruiting, patients are assigned to the electro-acupuncture group by randomization,and then receive electro-acupuncture treatment.Both treatments consist of 24 sessions of 30 minutes duration, administered over 8 weeks (usually three sessions per week). Participants in both groups will be evaluated at baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks.
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.
Experimental: Manual acupuncture group
After recruiting, patients are assigned to the manual acupuncture group by randomization,and then receive manual acupuncture treatment.Both treatments consist of 24 sessions of 30 minutes duration, administered over 8 weeks (usually three sessions per week). Participants in both groups will be evaluated at baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks.
Device: 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.

Detailed 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.
  Eligibility

Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03274713

Contacts
Contact: Cunzhi Liu, M.D 010-52176043 lcz623780@126.com
Contact: Yongting Li, Postgraduate Student 15210518799 liyong_ting@126.com

Locations
China, Beijing
Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University Not yet recruiting
Beijing, Beijing, China, 100000
Sponsors and Collaborators
zhouping
Beijing Friendship Hospital
Beijing Jishuitan Hospital
Investigators
Study Director: Cunzhi Liu, M.D Beijing Hospital of Traditional Chinese Medicine
  More Information

Responsible Party: zhouping, Postgraduate Student, Beijing Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03274713     History of Changes
Other Study ID Numbers: 2017BL-020-01
Study First Received: August 30, 2017
Last Updated: September 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 21, 2017