Traditional Chinese acupuncture for mild to moderate knee osteoarthritis
| ISRCTN | ISRCTN14016893 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14016893 |
| Secondary identifying numbers | XMLX201607 |
- Submission date
- 04/04/2016
- Registration date
- 04/07/2016
- Last edited
- 18/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
23 Meishuguanhou Street
Dongcheng District
Beijing
100010
China
Study information
| Study design | Two-arm randomized controlled pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Traditional Chinese Acupuncture vs minimal acupuncture for mild to moderate Knee OsteoArthritis: a randomized controlled pilot trial |
| Study acronym | CAKOA-I |
| Study objectives | Acupuncture at acupoints is more effective than minimal acupuncture in the treatment of mild-moderate knee osteoarthritis. |
| Ethics approval(s) | Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, 14/03/2016, ref: 2016BL-010-02 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/12/2015 |
| Completion date | 30/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 45 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 42 |
| Key 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 6 months 4. Morning stiffness at most 30 minutes 5. Signed informed consent |
| Key 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 |
| Date of first enrolment | 30/04/2016 |
| Date of final enrolment | 30/06/2016 |
Locations
Countries of recruitment
- China
Study participating centres
Dongcheng District
Beijing
100010
China
Xicheng District
Beijing
100050
China
Xicheng District
Beijing
100000
China
Sponsor information
Government
70 Zaolin Front Street
Xicheng District
Beijing
100035
China
"ROR" |
https://ror.org/04baakq55 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/03/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Cun-Zhi Liu at lcz623780@126.com. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 20/12/2017 | 06/02/2018 | No | No | |
| Protocol article | 13/12/2016 | 18/08/2023 | Yes | No |
Additional files
- ISRCTN14016893_BasicResults_20Dec17.pdf
- Uploaded 06/02/2018
Editorial Notes
18/08/2023: Publication reference added.
06/02/2018: The participant level data-sharing statement has been added. The basic results of this trial have been uploaded as an additional file.
