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
Secondary identifying numbers SR-2
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

Department of Acupuncture and Moxibustion
Dongguk University International Hospital
814, Siksa-dong
Ilsandong-gu
Goyang-si,Gyeonggi-do
411-773
Korea, South

Study information

Study designTwo-armed, single blinded, randomided, controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleA 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 acronymThe effectiveness of Individualised Acupuncture for Knee Osteoarthritis
Study objectivesTo 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) studiedKnee Osteoarthritis
InterventionArm A: Individualised traditional Korean acupuncture
Arm B: Standardised acupuncture
Intervention typeOther
Primary outcome measurePain rating based on a 100 mm VAS
Secondary outcome measures1. 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 study start date01/05/2006
Completion date01/02/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants50
Key inclusion criteria1. 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 criteria1. 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 enrolment01/05/2006
Date of final enrolment01/02/2007

Locations

Countries of recruitment

  • Korea, South

Study participating centre

Department of Acupuncture and Moxibustion
Goyang-si,Gyeonggi-do
411-773
Korea, South

Sponsor information

Korea Institute of Oriental Medicine (South Korea)
Research organisation

461-24, Jeonmin-dong
Yuseong-gu
Daejeon
305-811
Korea, South

Website http://www.kiom.re.kr/english/
ROR logo "ROR" https://ror.org/005rpmt10

Funders

Funder type

Research organisation

Korea Institute of Oriental Medicine (South Korea)
Government organisation / National government
Alternative name(s)
KIOM
Location
Korea, South

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.