Our study compares the effect of exercise therapy and manipulation in Sacroiliac dysfunction. The patients will be divided in three groups randomly by the table of random numbers. One group will take manipulative techniques and exercise therapy. These patients will do exercises protocol for 3 months after taking manipulation techniques twice at the first session. The second group will take only two manipulative techniques and the patients will do self-mobilization techniques for 3 months daily. The third group will do only exercise for three months. All of the patients will be visited once a week for 3 months. The patients can use 100 mg Diclofenac a day if they have VAS > 5. The patients will be followed in 6, 12, 24 weeks after initiation of treatment. Severity of pain will be evaluated by Visual Analog Scale (VAS). Disability will be evaluated by ODI and Roland Morris Questionnaires and functional tests before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412144409N4
Registration date:2015-02-01, 1393/11/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-01, 1393/11/12
Registrant information
Name
Parisa Nejati
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4480 0361
Email address
parisanejati@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-01-30, 1393/11/10
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of manipulative techniques and exercise therapy on pain and function in patients with Sacroiliac joint dysfunction
Public title
Exercise therapy and manipulation in sacroiliac dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age older than 20, low back pain or buttock pain at least for 3 months, no surgery in spine or pelvis in last year, not pregnant, at least 3 positive tests of following tests: Standing forward bending Test, Faber Test, Gilet Test, Yeoman Test, Ganselen Test, no severe osteoporosis or bone fracture, no radicular pain to below the knee, not using physical modalities in low back or buttock in last month, not using corticosteroid injection in sacroiliac joint in last month, no sacroileitis or sacroiliac joint infection.
Exclusion criteria:
Exacerbation of pain that need a different therapeutic approach
Age
From 20 years old to 100 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Vice chancellor for research, second floor, medicine faculty, Iran University of Medical Sciences, next to Milad tower, Hemmat highway
City
Tehran
Postal code
Approval date
2014-09-09, 1393/06/18
Ethics committee reference number
93-02-30-24400-103949
Health conditions studied
1
Description of health condition studied
Low back pain / Sacroiliac joint dysfunction
ICD-10 code
M-53.3 , M
ICD-10 code description
Sacrococcygeal disorders, not elsewhere classified low back pain
Primary outcomes
1
Description
Pain
Timepoint
Before intervention, 6 , 12 and 24 weeks after intervention
Method of measurement
visual analog scale
2
Description
function and ability
Timepoint
before intervention, 6 , 12 and 24 weeks after intervention
Method of measurement
Rollandmorris, ODI questionnaires
Secondary outcomes
1
Description
function
Timepoint
before intervention , 12, 24 weeks after intervention
Method of measurement
timed up and go test , Self-paced walk test
Intervention groups
1
Description
After two techniques of manipulation, stretching exercises and core exercises and self- mobilization techniques will be educated to patient. They will do each exercise 3 times a day and repeat each exercise 5 times that long 20 seconds.
Category
Rehabilitation
2
Description
Second group take 2 techniques of manipulation. The patients will do self mobilization techniques 3 times a day without extra exercises for 3 months.
Category
Rehabilitation
3
Description
Third group take exercise without manipulation. They will do sacroiliac stretching exercises, core exercises, self mobilization exercises 3 times a day for 3 months. Each exercises longs for 20 seconds.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram hospital
Full name of responsible person
Parisa Nejati, Assistant professor of sports medicine
Street address
Sports medicine department, Eight floor, Rasool Akram hospital, Niyayesh street, Satarkhan street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
Vice chancellor for research, fifth floor, central building, Iran University of Medical Sciences, next to Millad tower, 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
Iran University of Medical Sciences, Vice chancellor for research
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 University of Medical Sciences
Full name of responsible person
Parisa Nejati
Position
Assistant professor of sports medicine
Other areas of specialty/work
Street address
Sports medicine department, eighth floor, Rasool Akram hospital, Niyayesh street, Satarkhan street
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2446
Fax
+98 21 6650 9108
Email
parisanejati@yahoo.com nejati.p@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Nejati
Position
Assistant professor of sports medicine
Other areas of specialty/work
Street address
Sports medicine department, eighth floor, Rasool Akram hospital, Niyayesh street, Satarkhan street
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2446
Fax
+98 21 6650 9108
Email
parisanejati@yahoo.comnejati.p@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Nejati
Position
Assisstant professor of sports medicine
Other areas of specialty/work
Street address
Sports medicine department, eighth floor, Rasool Akram hospital, Niyayesh street, Satarkhan street
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2446
Fax
+98 21 6650 9108
Email
parisanejati@yahoo.comnejati.p@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)