A randomised, single-blind, two-limbed, parallel-group study to compare the effectiveness of 'individualised traditional Korean acupuncture' with one of 'standardised acupuncture' in Korean patients with knee osteoarthritis
| ISRCTN | ISRCTN40706107 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40706107 |
| Protocol serial number | SR-2 |
| Sponsor | Korea Institute of Oriental Medicine (South Korea) |
| Funder | Korea Institute of Oriental Medicine (South Korea) |
- Submission date
- 27/10/2006
- Registration date
- 16/01/2007
- Last edited
- 14/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Seung-deok Lee
Scientific
Scientific
Department of Acupuncture and Moxibustion
Dongguk University International Hospital
814, Siksa-dong
Ilsandong-gu
Goyang-si,Gyeonggi-do
411-773
Korea, South
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-armed, single blinded, randomided, controlled trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised, single-blind, two-limbed, parallel-group study to compare the effectiveness of 'individualised traditional Korean acupuncture' with one of 'standardised acupuncture' in Korean patients with knee osteoarthritis |
| Study acronym | The effectiveness of Individualised Acupuncture for Knee Osteoarthritis |
| Study objectives | To determine whether individualised acupuncture provides greater pain relief compared with standardised acupuncture in patients with OsteoArthritis (OA) of the knee. |
| Ethics approval(s) | This trial was approved by an ethics board of Dongguk International Hospital on 23rd May 2006. |
| Health condition(s) or problem(s) studied | Knee Osteoarthritis |
| Intervention | Arm A: Individualised traditional Korean acupuncture Arm B: Standardised acupuncture |
| Intervention type | Other |
| Primary outcome measure(s) |
Pain rating based on a 100 mm VAS |
| Key secondary outcome measure(s) |
1. Western Ontario MacMaster Questionnaire (WOMAC) Scale |
| Completion date | 01/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. At least 40 years old 2. Current symptoms of chronic (six months), stable pain and/or stiffness in one or both knees during weight-bearing activities 3. Knee pain due to OA rated more than 4 cm on a 10 cm Visual Analogue Scale (VAS) in one or both knees 4. Morning stiffness of knee for less than or equal to 30 minutes 5. Mild joint space narrowing (more than or equal to 2 mm remaining) in knee AnteroPosterior (AP) standing or Rosenberg view |
| Key exclusion criteria | 1. Inflammatory, metabolic, or neuropathic arthropathies 2. Trauma or surgery to the knee(s) which is causing pain or functional problems within six months prior to the enrolment period 3. Suspicious meniscus injury by physical examination 4. Pain emanating more from back or hip than from knee, interfering with patient knee assessment 5. Any condition which severely limits local ambulation, such as amputation or stroke 6. History of or evidence of active rheumatologic disease, severe peripheral neuropathy, clinically evident cardiac or respiratory disease that interferes with functional status, or other serious diseases, including psychiatric disorders 7. Autoimmune disease, Systemic Lupus Erythematosus (SLE), psoriatic arthritis, active (redness, swelling, fever, etc.) gout or pseudo-gout within six months prior to screening 8. History of prolotherapy, or injection of hyaluronic acid or cortisone within the last three months 9. Inability to stop anti-inflammatory medication or Non Steroidal Anti-Inflammatory Drug (NSAID) such as acetaminophen for the entire study 10. Bleeding disorders that might contraindicate acupuncture 11. Pension or disability benefits |
| Date of first enrolment | 01/05/2006 |
| Date of final enrolment | 01/02/2007 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Department of Acupuncture and Moxibustion
Goyang-si,Gyeonggi-do
411-773
Korea, South
411-773
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 30/12/2006 | 14/01/2021 | Yes | No |
Editorial Notes
14/01/2021: Publication reference added.
