NCT03274713

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

September 7, 2017

Status Verified

September 1, 2017

Enrollment Period

4 months

First QC Date

August 30, 2017

Last Update Submit

September 5, 2017

Conditions

Osteoarthritis Of Knee

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Pain

    baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks

  • Stiffness

    baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks

  • Knee-joint function

    baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks

  • Quality of life

    baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks

  • Number of emergency analgesics (Celebrex/Loxonin) used

    baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks

  • +3 more secondary outcomes

Study Arms (2)

Electro-acupuncture group

EXPERIMENTAL

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

Manual acupuncture group

EXPERIMENTAL

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

Interventions

Electro-acupunctureDEVICE

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.

Electro-acupuncture group
Manual acupunctureDEVICE

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.

Manual acupuncture group

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • VAS ≥ 40mm
  • Signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (3)

  • Shi GX, Tu JF, Wang TQ, Yang JW, Wang LQ, Lin LL, Wang Y, Li YT, Liu CZ. Effect of Electro-Acupuncture (EA) and Manual Acupuncture (MA) on Markers of Inflammation in Knee Osteoarthritis. J Pain Res. 2020 Aug 26;13:2171-2179. doi: 10.2147/JPR.S256950. eCollection 2020.

    PMID: 32904642DERIVED

  • Wang TQ, Li YT, Wang LQ, Shi GX, Tu JF, Yang JW, Hou YQ, Lin LL, Sun N, Zhao JJ, Hou HK, Liu CZ. Electroacupuncture versus manual acupuncture for knee osteoarthritis: a randomized controlled pilot trial. Acupunct Med. 2020 Oct;38(5):291-300. doi: 10.1177/0964528419900781. Epub 2020 Feb 5.

    PMID: 32022581DERIVED

  • Tu JF, Yang JW, Lin LL, Wang TQ, Du YZ, Liu ZS, Hu H, Zhao JJ, Yu XG, Jia CS, Wang J, Wang T, Hou YQ, Zou X, Wang Y, Shao JK, Wang LQ, Yu ZS, Liu CZ. Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial. Trials. 2019 Jan 25;20(1):79. doi: 10.1186/s13063-018-3138-x.

    PMID: 30683147DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Cunzhi Liu, M.D

    Beijing Hospital of Traditional Chinese Medicine

    STUDY DIRECTOR

Central Study Contacts

Cunzhi Liu, M.D

CONTACT

010-52176043lcz623780@126.com

Yongting Li, Postgraduate Student

CONTACT

15210518799liyong_ting@126.com

Study Design

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

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 7, 2017

Study Start

September 1, 2017

Primary Completion

December 31, 2017

Study Completion

February 28, 2018

Last Updated

September 7, 2017

Record last verified: 2017-09

Locations

CN(1)