Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SR-2
Study information
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
Acronym
The effectiveness of Individualised Acupuncture for Knee Osteoarthritis
Study hypothesis
To determine whether individualised acupuncture provides greater pain relief compared with standardised acupuncture in patients with OsteoArthritis (OA) of the knee.
Ethics approval
This trial was approved by an ethics board of Dongguk International Hospital on 23rd May 2006.
Study design
Two-armed, single blinded, randomided, controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Knee Osteoarthritis
Intervention
Arm A: Individualised traditional Korean acupuncture
Arm B: Standardised acupuncture
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Pain rating based on a 100 mm VAS
Secondary outcome measures
1. Western Ontario MacMaster Questionnaire (WOMAC) Scale
2. Quality of Life (Short Form health survey [SF-36])
3. Lequesne Functional Index (LFI) score
4. Physical function was evaluated by the Korean version of Health Assessment Questionnaire (KHAQ)
Overall trial start date
01/05/2006
Overall trial end date
01/02/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
50
Participant 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
Recruitment start date
01/05/2006
Recruitment end date
01/02/2007
Locations
Countries of recruitment
Korea, South
Trial participating centre
Department of Acupuncture and Moxibustion
Goyang-si,Gyeonggi-do
411-773
Korea, South
Sponsor information
Organisation
Korea Institute of Oriental Medicine (South Korea)
Sponsor details
461-24
Jeonmin-dong
Yuseong-gu
Daejeon
305-811
Korea
South
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Korea Institute of Oriental Medicine (South Korea)
Alternative name(s)
KIOM
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Korea, South
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2020 protocol in http://www.koreascience.or.kr/article/JAKO200618317168492.j (added 14/01/2021)