Condition category
Musculoskeletal Diseases
Date applied
09/03/2005
Date assigned
07/11/2006
Last edited
11/05/2007
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 M Fathy ElBatouty

ORCID ID

Contact details

Mansoura University Hospitals
Mansoura
11135
Egypt
amalfehr@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

21161

Study information

Scientific title

Acronym

APOA-Eg

Study hypothesis

Effect of acupuncture on markers of knee OsteoArthritis (OA) in Egyptians.

Ethics approval

Rheumatology and Physical Medicine Department, Faculty of medicine, Mansoura University (Egypt).

Study design

Randomised three armed prospective study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Knee osteoarthritis (OA)

Intervention

Two groups receive verum (real) acupuncture either with manual manipulation, or with electro-acupuncture, and the third sham (control) acupuncture.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Western Ontario and McMaster Universities Arthritis Index (WOMAC) scale

Secondary outcome measures

Immunological study for adhesion molecules such as intercellular adhesion molecule 1 (ICAM1) and cytokines such as interleukin-1beta (IL1B) and Tumor Necrosis Factor (TNF) alpha, before and after treatment.

Overall trial start date

01/06/2005

Overall trial end date

01/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients are included if they:
1. Agreed to participate in the study by written, informed consent
2. Fulfilled the American College of Rheumatology criteria for knee OA

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

300 patients with knee OA

Participant exclusion criteria

1. Non-compliance
2. High serum uric acid

Recruitment start date

01/06/2005

Recruitment end date

01/06/2007

Locations

Countries of recruitment

Egypt

Trial participating centre

Mansoura University Hospitals
Mansoura
11135
Egypt

Sponsor information

Organisation

Mansoura University Hospital (Egypt)

Sponsor details

Elgomhoria Street
Mansoura Faculty of Medicine
Mansoura
35516
Egypt
+20 502247055
mua@mans.edu.eg

Sponsor type

Hospital/treatment centre

Website

http://www.mans.eun.eg/english/

Funders

Funder type

Other

Funder name

Investigator funded trial - no external funding was gained for this trial.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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