Evaluation of the effects of phonophoresis of Carum Copticum extract on pain and function in the first two weeks after anterior cruciate ligament repair.
Evaliating the effects of phonophoresis of Carum Copticum extract on pain and function of patients in the first two weeks after anterior cruciate ligament reconstruction.
Design
A Clinical trial with parallel control group, triple blind, Randomized
Settings and conduct
After assignment of patients to intervention or control groups, participants refer to physical therapy clinic of Shiraz University of Medical Sciences and receive the above mentioned treatment. The therapist is unaware of group assignment and also the assessor is unaware of group assignment and treatment and evaluate the patients at the beginning and end of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age older than 18 years old; no injuries to the lower extremities during the past 6 months; unilateral repair of anterior cruciate ligament; the patient has undergone anterior cruciate ligament repair for the first time; lower extremity deformities.
Exclusion criteria: systemic diseases like diabetes according to doctor diagnosis of specialist; patients with allergy to Carum Copticum.
Intervention groups
Intervention group: interventions of first weak includes stretching exercises, and muscle setting exercises of the muscles of lower extremities that abdominal and core strengthening exercises and ambulation are added at second weak. during two weak of treatment, electrotherapy using Russian current on quadriceps muscle to strengthen the muscle is engaged. Phonophoresis of the extract of Carum Copticum for 5-10 minutes is applied on reconstructed knee.
Control group: All methods are the same as intervention group but instead of the phonophoresis of Carum Copticum extract, routine aquagel would be used.
Main outcome variables
pain; inflammation; range of motion; weight tolerance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160614028447N7
Registration date:2020-01-16, 1398/10/26
Registration timing:prospective
Last update:2020-01-16, 1398/10/26
Update count:0
Registration date
2020-01-16, 1398/10/26
Registrant information
Name
Amin Kordi Yoosefinejad
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 1081
Email address
yoosefinejad@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2020-08-05, 1399/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of phonophoresis of Carum Copticum extract on pain and function in the first two weeks after anterior cruciate ligament repair.
Public title
Evaluating the effects of Carum Copticum extract on pain and function of patients after anterior cruciate ligament repair.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18
No injuries to the lower extremities during the past 6 months
Unilateral repair of anterior cruciate ligament
The patient has undergone anterior cruciate ligament repair for the first time
Lower extremity malformations
Exclusion criteria:
Systemic diseases like diabetes with a doctor's diagnosis
Patients who have allergies to women
Age
From 18 years old to 45 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization would be performed with block randomization method with block size of 4 using statistical software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
To blind the participants, a little amount of Carum Capticum gel with 0.5% concentration would be added to routine gel in ultrasound therapy to have similar smelling with produced gel from Carum Capticum. Also, the researcher, assessor, and analyser are blind about group assignment and activity of other members of research group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee on Ethics in Biomedical Research
Street address
Sheikh Abivardi 1, Chamran Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
3366971947
Approval date
2019-12-28, 1398/10/07
Ethics committee reference number
IR.SUMS.REHAB.REC.1398.044
Health conditions studied
1
Description of health condition studied
Anterior cruciate ligament repair
ICD-10 code
S83.5
ICD-10 code description
Sprain of cruciate ligament of knee
Primary outcomes
1
Description
Pain with visual analogue scale (VAS)
Timepoint
At the beginning of study and at the end of study (after 2 weaks)
Method of measurement
With visual analogue scale which is a 10-cm straight line with zero as without pain at one end and 10 as maximum pain at the other end. The participant sign a part of line with equals his/her pain and the sign is measured with ruler and recorded as pain measure.
Secondary outcomes
1
Description
Inflammation
Timepoint
At the beginning of study and at the end (after two weeks of interventions)
Method of measurement
Tape measurement at 15 cm below the central point of patella and 5, 10, 23 cm below the patella on both lower extremities.
2
Description
Passive and active range of motion of involved and sound knees
Timepoint
Before the beginning of study and at the end of study after 2 weeks of intervention
Method of measurement
Manual goniometry and Kinovea software
3
Description
Weight tolerance on involved knee
Timepoint
Before the beginning of study and after 2 weeks of intervention
Method of measurement
Digital scale
Intervention groups
1
Description
Intervention group: stretching of tight soft tissues, strengthening and setting exercises of knee muscles, core training, ambulation, electrotherapy using Russian current, stimulation parameters: 2500 Hz, Burst: 75, ramp up: 12 sec, 12 sec: on, 50 sec: off, Carum Copticum extract phonoresis with frequency of 1 MHz, intensity of 1.5 W/cm2 for 5-10 minutes based on the volume of patients' knee
Category
Rehabilitation
2
Description
Control group: Stretching of tight soft tissues, strengthening and setting exercises, core training ambulation, electrotherapy using Russian current, stimulation parameters: frequency: 2500 Hz, Burst: 75, ramp up: 2 sec, on time: 12 sec, off time: 50 sec, Routine ultrasound therapy with frequency if 1 MHz, intensity of 1.5 W/cm2, for 5-10 minutes based on the volume of patients' knee
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaee hospital, Namazi hospital, Research center of Rehabilitation Sciences
Full name of responsible person
Amin Kordi Yoosefinejad
Street address
Sheikh Abivardi 1, Chamran Blvd., School of Rehabilitation Sciences
City
Shiraz
Province
Fars
Postal code
3366971947
Phone
+98 71 3626 1081
Fax
+98 71 3627 2495
Email
yoosefinejad@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yoones Ghasemi
Street address
No. 1, Sheikh Abivardi Ave., Chamran Blvd., School of Rehabilitation Sciences
City
Shiraz
Province
Fars
Postal code
3366971947
Phone
+98 71 3626 1081
Email
yoosfinejad@sums.ac.ir
Grant name
Vice chancellor of research of Shiraz University of Medical Sciences
Grant code / Reference number
97-01-06-18590
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amin kordi Yoosefinejad
Position
assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No. 1, Sheikh Abivari Ave., Chamran Blvd., School of Rehabilitation Sciences
City
Shiraz
Province
Fars
Postal code
3366971947
Phone
+98 71 3626 1081
Email
yoosfinejad@sum.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amin kordi Yoosefinejad
Position
assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No. 1, Sheikh Abivardi Ave., Chamran Blvd., School of Rehabilitation Sciences
City
Shiraz
Province
Fars
Postal code
3366971947
Phone
+98 71 3626 1081
Email
yoosfinejad@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amin kordi Yoosefinejad
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No. 1, Sheikh Abivardi Avd., Chamran Blvd., School of Rehabilitation Sciences
City
Shiraz
Province
Fars
Postal code
3366971947
Phone
+98 71 3626 1081
Email
yoosfinejad@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data except personal information would be available.
When the data will become available and for how long
All data except personal information would be available.
To whom data/document is available
researchers of universities and scientific academies
Under which criteria data/document could be used
Researchers can use data for advanced analyses or for meta analysis studies.
From where data/document is obtainable
Dr. Amin Kordi Yoosefinejad, Shiraz, Chamran Blvd., Sheikh Abivardi 1 ave., School of Rehabilitation Sciences, Mobile: 09171950589, E-mail: yoosefinejad@sums.ac.ir
What processes are involved for a request to access data/document
After written request and precise explanation about using of data, data would be sent to researcher within a week.