The objective of this randomized trial is to investigate the effect of Glucosamine combinations phonophoresis on knee osteoarthrosis. In this study 36 patients with osteoarthrosis who meet the inclusion/exclusion criteria will be recruited and randomly assigned into intervention or control group. The patients in the intervention group will receive phonophoresis of glucosamine through application of therapeutic ultrasound. The patients in one control group will receive therapeutic ultrasound and the other control group will receive placebo ultrasound. All three groups would receive standard treatment include: IR (Infra Red), TENS (Transcutaneous Electrical Nerve Stimulation) and SLR exercise (Straight Leg Raising to strengthen quadriceps muscle). All treatment sessions last for 10 sessions. Pain, active knee flexion range of motion, swelling of knee joint, morning stiffness and quality of life of all participants will be measured before and after the intervention and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111014203N2
Registration date:2011-11-22, 1390/09/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-11-22, 1390/09/01
Registrant information
Name
Atefeh Aminian Far
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4180
Email address
aminianfar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Semnan University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-02-19, 1390/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the efficacy of Glucosamine phonophoresis in knee osteoarthrosis
Public title
Efficacy of Glucosamine in knee osteoarthrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of mechanical knee pain, osteophytes in knee X-ray, age above 50 years, morning stiffness lasting less than 30 minutes, crepitus in palpation of knee joint.
Exclusion criteria: presence of other knee joint diseases, osteoarthrosis of hip and/or ankle joints, radicular pain originating from lumbar spine, physiotherapy history with intra/peri articular injection (corticosteroids or hyaluronic acid) during past six months, physiotherapy history during past six months, surgery history of knee joints, psychotic or mental disorders, neoplasm, infections, bleeding, neurologic disorders (sensory or motor)
Age
From 50 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of Research, Semnan University of Medical Sciences
Street address
Bassij Blvd, Semnan University of Medical Sciences, Deputy of Research, Semnan, Iran.
City
Semnan
Postal code
3519899951
Approval date
2011-09-26, 1390/07/04
Ethics committee reference number
114743/90
Health conditions studied
1
Description of health condition studied
Osteoarthrosis
ICD-10 code
M15.4
ICD-10 code description
Erosive (osteo)arthrosis
Primary outcomes
1
Description
Quality of Life
Timepoint
Before treatment and after 10 treatment sessions .
Method of measurement
WOMAC INDEX Questionaire
2
Description
Duration of Morning stifness
Timepoint
Before treatment and after 10 treatment sessions .
Method of measurement
Based on scale of 0-4
3
Description
Measurement of resting and activity pain
Timepoint
Before treatment and after 10 treatment sessions .
Method of measurement
Based on Visual Analogue Scale (0-10)
4
Description
Active range of motion of knee flexion
Timepoint
Before treatment and after 10 treatment sessions .
Method of measurement
Based on Goniometery
5
Description
Swelling of knee joint
Timepoint
Before treatment and after 10 treatment sessions .
Method of measurement
Based on tape measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention (3, Phonophoresis of glucosamine): Standard treatment (includes: IR, TENS and Exercise) with phonophoresis of glucosamine. Standard treatment includes: IR lasting for 20 minutes in distance of 40-50 cm from knees, TENS in form of high TENS (f=50-100 Hz, pulse time of 0/05 ms, low intensity level at tingling sensation), placing electrodes at knee joint line around the patella, for 15 minutes and SLR exercise, raising limb from the table at distance of 5 inches to strengthen quadriceps muscle. Ultrasound applied continuously, in combination of 50% gel and 50% glucosamine ointment, frequency of 1 MHz with the intensity of 2 watt/cm2 and duration of 5 minutes increasing gradually during the treatment sessions. For 10 sessions.
Category
Treatment - Other
2
Description
Intervention (2, Ultrasound): Standard treatment (includes: IR, TENS and Exercise) with US. Standard treatment includes : IR lasting for 20 minutes in distance of 40-50 cm from knees, TENS in form of high TENS (f=50-100 Hz, pulse time of 0/05 ms, low intensity level at tingling sensation), placing electrodes at knee joint line around the patella, for 15 minutes and SLR exercise, raising limb from the table at distance of 5 inches to strengthen quadriceps muscle. Ultrasound applied continuously, frequency of 1 MHz with the intensity of 2 watt/cm2 and duration of 5 minutes increasing gradually during the treatment sessions. For 10 sessions.
Category
Treatment - Other
3
Description
Intervention (1, Placebo US): Standard treatment (includes: IR, TENS and Exercise) with placebo US. Standard treatment includes: IR lasting for 20 minutes in distance of 40-50 cm from knees, TENS in form of high TENS (f=50-100 Hz, pulse time of 0/05 ms, low intensity level at tingling sensation), placing electrodes at knee joint line around the patella, for 15 minutes and SLR exercise, raising limb from the table at distance of 5 inches to strengthen quadriceps muscle. Placebo ultrasound for 5 minutes, around the knee joint. For 10 sessions.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics under supervision of Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research, Semnan University of Medical Sciences
Full name of responsible person
Dr. Raheb Ghrbani
Street address
Bassij Blvd, Semnan University of Medical Sciences, Deputy of Research, Semnan, Iran.
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, Semnan University 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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Postal code
1439957181
Phone
+98 23 1335 4182
Fax
+98 23 1335 4180
Email
aminfar83@yahoo.com aminianfar@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Postal code
1439957181
Phone
+98 23 1335 4182
Fax
+98 23 1335 4180
Email
aminfar83@yahoo.com aminianfar@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Postal code
1439957181
Phone
+98 23 1335 4182
Fax
+98 23 1335 4180
Email
aminfar83@yahoo.com aminianfar@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)