Protocol summary

Summary
Aim: to compare the effects of acupuncture, physical modality and home based exercise training on symptoms of knee osteoarthritis. Patients: all patients with knee osteoarthritis, according to American college of rheumatology (ACR) criteria, referred to the clinic of physical therapy in Firoozgar hospital, Tehran, Iran. Main inclusion criteria were knee pain lasting for 6 months or longer and age between 40-65 years. Main exclusion criteria were receiving NSAIDs during study and exacerbation of symptoms. Sixty patients with knee osteoarthritis were randomly divided into three groups (A,B and C) .The acupuncture group (A) received only acupuncture at selected acupoint for knee pain; the physical modality group (B) received TENS (transcutaneous Electrical Nerve Stimulation), ultrasound and hot pack at pain areas .The exercise group (C) received isometric exercise of the knee. Each group received treatment 3 sessions per week for 4 weeks. Evaluating measurement tools were Visual Analogue Scale (VAS) for pain intensity and KOOS questionnaire for function.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138811163284N1
Registration date: 2009-04-21, 1388/02/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-04-21, 1388/02/01
Registrant information
Name
Dr Bijan Forogh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1229
Email address
bijhanfr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Iran univercity of medical sciences
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2009-11-30, 1388/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of acupuncture, physical modality and home based exercise training on symptoms of knee osteoarthritis
Public title
Effects of acupuncture, physiotherapy and exercise training on knee arthrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Male and female with knee pain lasting for 6 months or longer 2-Age between 40-65 years 3-Normal neurological examination 4-At least one osteophyte at tibiofemoral joint (Kellgren- Lawrence grade >2) 5-Not receiving intra articular injection from 3 months ago 6- Not consuming NSAIDs during last week before study 7-No history of knee surgery 8-No history of treatment with acupuncture 9-No history of cancer, pregnancy and secondary osteoarthritis. Exclusion criteria: 1-Low adherence to treatment 2-Receiving NSAIDs during study 3-Exacerbation of symptoms.
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice Chancellor for Research, Iran univercity of medical sciences
Street address
Hemmat highway
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
8512

Health conditions studied

1

Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Other primary gonarthrosis

Primary outcomes

1

Description
pain, symptoms, and activities of daily living
Timepoint
Before and after treatment
Method of measurement
Koos questionnare

2

Description
Pain
Timepoint
Before and after treatment
Method of measurement
Visual Analogue Scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
The acupuncture group (A): acupuncture at selected acupoint for knee pain, 3 sessions per week for 4 weeks
Category
Rehabilitation

2

Description
The physical modality group (B): TENS (transcutaneous electrical nerve stimulation), ultrasond and hot pack at pain areas, 3 sessions per week for 4 weeks.
Category
Rehabilitation

3

Description
The exercise group (C):isometric exercise of the knee, 3 sessions pr week for 4 weeks
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Dr Bijan Forogh, MD
Street address
Behafarin street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Iran univercity of medical sciences
Full name of responsible person
Dr Said Abbas Motavalian
Street address
Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Iran univercity of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran univercity of medical sciences
Full name of responsible person
Dr Mohammad Saleki, MD
Position
Sport medicin resident
Other areas of specialty/work
Street address
Firoozgar Hospital
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
+98 21 8894 2970
Email
drsaleki@yahoo.com , tannaz.ahadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran univercity of medical sciences
Full name of responsible person
Dr Tannaz Ahadi, MD
Position
Assistant Professor / Physiatrist
Other areas of specialty/work
Street address
Firoozgar Hospital, Behafarin street
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
+98 21 8894 2970
Email
drsaleki@yahoo.com , tannaz.ahadi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran univercity of medical sciences
Full name of responsible person
Dr Mohammad Saleki, MD
Position
Sport medicine resident
Other areas of specialty/work
Street address
Firoozgar Hospital, Behafarin street
City
Tehran
Postal code
1593748711
Phone
+98 21 8214 1229
Fax
+98 21 8894 2970
Email
drsaleki@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...