Condition category
Musculoskeletal Diseases
Date applied
27/10/2006
Date assigned
16/01/2007
Last edited
16/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Seung-deok Lee

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SR-2

Study information

Scientific title

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 measures

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

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

http://www.kiom.re.kr/english/

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

Federal/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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes