Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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IRCT |
Last refreshed on:
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22 February 2018 |
Main ID: |
IRCT201111014203N2 |
Date of registration:
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2011-11-22 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Efficacy of Glucosamine in knee osteoarthrosis
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Scientific title:
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Study the efficacy of Glucosamine phonophoresis in knee osteoarthrosis |
Date of first enrolment:
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2011-09-23 |
Target sample size:
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36 |
Recruitment status: |
Complete |
URL:
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http://en.irct.ir/trial/4427 |
Study type:
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interventional |
Study design:
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Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Dr. Atefeh Aminian Far
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Address:
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Kilometer 5 Damghan road, Semnan University of Medical Sciences
1439957181
Semnan
Iran (Islamic Republic of) |
Telephone:
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+98 23 1335 4182 |
Email:
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aminfar83@yahoo.com aminianfar@razi.tums.ac.ir |
Affiliation:
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Semnan University of Medical Sciences |
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Name:
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Dr. Atefeh Aminian Far
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Address:
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Kilometer 5 Damghan road, Semnan University of Medical Sciences
1439957181
Semnan
Iran (Islamic Republic of) |
Telephone:
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+98 23 1335 4182 |
Email:
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aminfar83@yahoo.com aminianfar@razi.tums.ac.ir |
Affiliation:
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Semnan University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion 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)
Exclusion criteria:
Age minimum:
50 years
Age maximum:
75 years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Osteoarthrosis. Erosive (osteo)arthrosis
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Erosive (osteo)arthrosis
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Intervention(s)
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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.
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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.
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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.
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Intervention 1: 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. Intervention 2: 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. Intervention 3: 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.
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Treatment - Other
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Primary Outcome(s)
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Measurement of resting and activity pain. Timepoint: Before treatment and after 10 treatment sessions . Method of measurement: Based on Visual Analogue Scale (0-10).
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Duration of Morning stifness. Timepoint: Before treatment and after 10 treatment sessions . Method of measurement: Based on scale of 0-4.
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Swelling of knee joint. Timepoint: Before treatment and after 10 treatment sessions . Method of measurement: Based on tape measurement.
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Active range of motion of knee flexion. Timepoint: Before treatment and after 10 treatment sessions . Method of measurement: Based on Goniometery.
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Quality of Life. Timepoint: Before treatment and after 10 treatment sessions . Method of measurement: WOMAC INDEX Questionaire.
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Source(s) of Monetary Support
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Deputy of Research, Semnan University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Deputy of Research, Semnan University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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