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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: IRCT
Last refreshed on: 26 March 2018
Main ID:  IRCT20090301001722N16
Date of registration: 2018-02-08
Prospective Registration: No
Primary sponsor: Tehran University of Medical Sciences
Public title: Effects of Spinal Manipulation and Muscle Energy Technique on Sacroiliac Joint Dysfunction.
Scientific title: Effects of Spinal Manipulation and Muscle Energy Technique on Pain, Function, Thickness of muscles for Patients with Sacroiliac Joint Dysfunction
Date of first enrolment: 2017-04-01
Target sample size: 44
Recruitment status: Complete
URL:  http://en.irct.ir/trial/1224
Study type:  interventional
Study design:  Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Four groups will be divided by simple random sampling by using Four alphabetic chance: A) First group, B) second group and C) third group. D) Fourth Group Patients will be assigned randomly in Four groups by Physical Therapist (Rabiya) by using concealed opaque envelope mentioning Specific Identity Numbers generated through Random Number Generator to avoid biasness, Blinding description: Double Blind: Assessor Blind: Data safety will be ensured by assigning Specific Identity numbers and all consent, readings forms will be placed in locker to bind Assessors (Arif, Amir). Patients Blind: Patients will be blinded from group treatments and Hypothesis by informing partial information regarding treatment.  
Phase:  N/A
Countries of recruitment
Pakistan
Contacts
Name: Dr.Mohammad-Reza Hadian Rasanani   
Address:  Rehabilitation Faculty, Pich e Shemiran, Enghelab Street Tehran Tehran Iran, Islamic Republic Of 1148965141 Tehran Tehran Iran, Islamic Republic Of 1417614411 Tehran Iran (Islamic Republic of)
Telephone: +98 21 8891 3469
Email: hadianrasan@gmail.com
Affiliation:  Rehabilitation Faculty,Department of Physiotherapy
Name: Dr. Mohammad Reza Hadian   
Address:  Rehabilitation Faculty, Pich e Shemiran, Enghelab Street Tehran Tehran Iran, Islamic Republic Of 1148965141 1417614411 Tehran Iran (Islamic Republic of)
Telephone: +98 21 8891 3469
Email: hadianrs@sina.tums.ac.ir
Affiliation:  Rehabilitation Faculty, Brain and Spinal Injury Research center (BASIR), Imam Khomeini Hospital
Key inclusion & exclusion criteria
Inclusion criteria: Age: 18-45years old with unilateral LBP upto knee
At least three out of six SIJ provocation tests must be positive.
Standing flexion test and seating flexion test must be positive.
Male
No strengthening exercise of muscles in last three months.
No surgical history
No disc pathology confirmed by MRI
No facet joint hypomobility
No ankylosing spondylitis

Exclusion criteria: Abnormal recording of thickness by ultrasound.
Over time and fatigability of subjects.
Unwillingness of subjects to continue testing


Age minimum: 18 years
Age maximum: 45 years
Gender: Male
Health Condition(s) or Problem(s) studied
M99.04
Sacroiliac Joint Dysfunction.
Diseases of the musculoskeletal system and connective tissue,Biomechanical lesions, not elsewhere classified,Segmental and somatic dysfunction,Sacral region
Intervention(s)
Intervention 1: Intervention group: Muscle Energy Technique. Treatment session will be twice a week for four weeks. Intervention 2: Intervention group: Spinal Manipulation Therapy. Treatment session will be twice a week for four weeks. Intervention 3: Intervention group: Muscle Energy with Spinal Manipulation Therapy. Treatment session will be twice a week for four weeks. Intervention 4: Control group: Conventional Therapy such as,Therapeutic Ultrasound. Treatment session will be twice a week for four weeks.
Primary Outcome(s)
Pain. Timepoint: Before Intervention,After One month,After three months follow up. Method of measurement: Numeric Pain Rating Scale.
Muscle Thickness (Rest,Contracted,Percent change). Timepoint: Muscle Thickness(at rest,contracted and Percent change) will be measured before treatment ,after treatment at one month and follow up three months. Method of measurement: Ultrasonography.
Secondary Outcome(s)
Function. Timepoint: Function will be measured before treatment , after treatment at one month and follow up three months. Method of measurement: Modified Oswestry Disability Index Score.
Secondary ID(s)
Source(s) of Monetary Support
Tehran University of Medical Sciences
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Tehran University of Medical Sciences
Results
Results available:
Date Posted:
Date Completed:
URL:
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