Condition category
Musculoskeletal Diseases
Date applied
04/04/2016
Date assigned
04/07/2016
Last edited
04/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Osteoarthritis (OA) is the most common type of arthritis and affects millions of people worldwide. It occurs when the protective cartilage on the end of bones wears away. The bones then rub against one another, causing stiffness, pain and a reduction in the range of movement. The knee is the most common joint to be affected by OA and in many sufferers, the pain prevents people from moving around leading to muscle weakness and disability. Acupuncture is a popular treatment taken from ancient Chinese medicine, in which fine needels are placed into the body at specific points. Studies have shown that it can help to stimulate nerves under the skin, causing the body to produce natural pain-relieving substances (endorphins). The aim of this study is to evaluate the effectiveness of acupuncture in reducing pain and improving function in patients with knee OA.

Who can participate?
Patients diagnosed with mild-moderate knee osteoarthritis.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive traditional Chinese acupuncture, which involves having needles placed in acupoints (locations on the body affected by acupuncture) which are stimulated manually for 10 seconds to create the intended sensation. Those in the second group receive minimal acupuncture, which involves having needles placed under the skin at non-acupoints very shallowly so that it does not cause the acupuncture sensation. Both groups receive 24, 20-minute sessions over eight weeks. Participants in both groups complete a number of questionnaires at the start of the study and then again after 8, 16 and 24 weeks to find out whether their pain levels have decreased and if their joint function has improved.

What are the possible benefits and risks of participating?
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 are warned of these potential side-effects before consenting to have acupuncture.

Where is the study run from?
1. Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (China)
2. Beijing Friendship Hospital Affiliated to Capital Medical University (China)
3. Beijing Ji Shui Tan Hospital (China)

When is the study starting and how long is it expected to run for?
December 2015 to December 2016

Who is funding the study?
Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support (China)

Who is the main contact?
Dr Cun-Zhi Liu
lcz623780@126.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Cun-Zhi Liu

ORCID ID

Contact details

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
23 Meishuguanhou Street
Dongcheng District
Beijing
100010
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

XMLX201607

Study information

Scientific title

Traditional Chinese Acupuncture vs minimal acupuncture for mild to moderate Knee OsteoArthritis: A randomized controlled pilot trial

Acronym

CAKOA-I

Study hypothesis

Acupuncture at acupoints is more effective than minimal acupuncture in the treatment of mild-moderate knee osteoarthritis.

Ethics approval

Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, 14/03/2016, ref: 2016BL-010-02

Study design

Two-arm randomized controlled pilot trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Osteoarthritis

Intervention

Participants are randomly allocated to one of two groups.

Intervention group: Participants are treated with Traditional Chinese Acupuncture for 8 weeks. Patients in Traditional Chinese Acupuncture group will be treated by use of 4-5 local acupuncture points from the following selection: ST34, ST35, ST 36, EX-LE2, EX-LE5, GB33, GB34, SP9, SP10, LV8 and Ahshi. Additionally, acupuncturists will select and needl 2-3 distant points from the following selection: GB31, GB36, GB39, GB41, ST40, ST41, LR3, BL60, SP6, KI3, LI4. Needles will be stimulated manually to achieve “De Qi” sensation for 10 seconds.

Control group: Participants are treated with minimal acupuncture for 8 weeks. Treatment in Minimal Acupuncture group will be performed at 6-8 non-acupuncture points. Needles will be placed at non-acupoints with a superficial puncture (2 mm in depth) to avoid “De Qi” and manual stimulation.

Both the Traditional Chinese Acupuncture and Minimal Acupuncture treatments consist of 24 sessions of 20 minutes duration, administered over 8 weeks (usually three sessions per week). Participants in both groups are followed up at the end of the intervention period (8 weeks), 16 weeks and 26 weeks.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Response rate is determined using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline and 8 weeks.

Secondary outcome measures

1. Pain is measured using WOMAC pain subscore at baseline, 8 weeks, 16 weeks and 26 weeks
2. Knee-joint function is measured using WOMAC functional subscore at baseline, 8 weeks, 16 weeks and 26 weeks
3. Number of emergency analgesics (Celebrex) used is recorded using Drug Use Form at 8 weeks, 16 weeks and 26 weeks
4. Quality of life is measured using the 12-Item Short Form Health Survey (SF-12) at baseline, 8 weeks, 16 weeks and 26 weeks
5. Adverse events are measured using Adverse Event Form at 8 weeks and 16 weeks

Overall trial start date

01/12/2015

Overall trial end date

30/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between 45 and 75 years
2. Pain in single or double knee joints for at least 6 months
3. Kellgren–Lawrence grade Ⅱ or Ⅲ in the last six months
4. Morning stiffness at most 30 minutes
5. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

42

Participant exclusion criteria

1. Surgery of the afflicted extremity or waiting for surgery
2. Knee pain induced by other conditions (bone tumor, bone fracture, acute infection, gout, etc.)
3. Serious organic or psychiatric diseases (epilepsy, depression, etc.)
4. Severe coagulopathy
5. Pregnant or breast-feeding
6. History of receiving acupuncture, physical therapy, rehabilitation, analgesia, anti-inflammatory medication or cartilage nutrition agent in the past week
7. Current gastrointestinal ulcer
8. Participation in another clinical study in the past three months
9. Inadequacy for this trial

Recruitment start date

30/04/2016

Recruitment end date

30/06/2016

Locations

Countries of recruitment

China

Trial participating centre

Beijing Hospital of Traditional Chinese Medicine
23 Meishuguanhou Street Dongcheng District
Beijing
100010
China

Trial participating centre

Beijing Friendship Hospital
36 Yong'an Road Xicheng District
Beijing
100050

Trial participating centre

Beijing Ji Shui Tan Hospital
31 Xinjiekou E Road Xicheng District
Beijing
100000

Sponsor information

Organisation

Beijing Municipal Administration of Hospitals

Sponsor details

70 Zaolin Front Street
Xicheng District
Beijing
100035
China

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support (code: XMLX201607)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

31/03/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes