Protocol summary

Summary
The aim of present study was to compare the effects of manipulation and stabilization exercise in patients with subacute or chronic sacroiliac dysfunction. Methods: Patients with subacute and chronic sacroiliac joint dysfunction for more than 4 weeks and less than 1 year were included in the study. A total of 27 patients were randomized to either manipulation (n=14) or to stabilization exercise (n=13). The patients underwent a two week treatment program in the manual therapy group and a 4-week treatment program in stabilization therapy group. Pain, Functional Disability (Oswestry Disability Index) and sacroiliac joint Test results were recorded before and immediately after the treatment period.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138808232708N1
Registration date: 2010-09-07, 1389/06/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-09-07, 1389/06/16
Registrant information
Name
Ali Ghanbari
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
ghanbary@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research Affairs, Shiraz University of Medical Sciences
Expected recruitment start date
2009-04-04, 1388/01/15
Expected recruitment end date
2009-08-21, 1388/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Manipulation as compared with stabilization exercise in sacroiliac joint dysfunction patients
Public title
A comparison between exercise therapy and manual therapy in treatment of low back pain patient with sacroiliac joint dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- age between 20- 60 years 2- subacute or chronic low back pain for more than 4 weeks, with pain localized to sacroiliac joint region .3- The diagnosis of sacroiliac dysfunction by clinical tests . Exclusion criteria:1- low back pain for more than 1 year,2- pain predominantly in cervical and thoracic pain 3- spondylosis and spondylolystesis 4-known lumbar disc herniation,5- pain below the knee ,6- a history of spinal surgery, 7- osteoporosis, 8-scoliosis,9- pregnancy, 10- malignancy, 11- low back pain less than 4 weeks (acute low back pain).
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
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 Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Postal code
7194733669
Approval date
2009-06-10, 1388/03/20
Ethics committee reference number
‍CT- 88- 4755

Health conditions studied

1

Description of health condition studied
sacroiliac joint dysfunction
ICD-10 code
M99
ICD-10 code description
Other disorders of the musculoskeletal system and connective tissue

Primary outcomes

1

Description
functional disability level
Timepoint
before and after the treatment
Method of measurement
The Oswestry low back pain Disability Questionnaire (OSW), Each item was scored on a 0- 5 scale, and the maximum score was 50 (total score divided by total possible score multiplied by 100%).

Secondary outcomes

1

Description
pain intensity
Timepoint
before and after the treatment
Method of measurement
Visual Analogue Scales, a 100 mm scale

2

Description
Sacroiliac Joint Tests
Timepoint
before and after the treatment
Method of measurement
The results of the five tests were recorded as positive or negative values

Intervention groups

1

Description
manipulation
Category
Treatment - Other

2

Description
exercise therapy
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Rehabilitation, Shiraz University of Medical Sciences
Full name of responsible person
Ali Ghanbari
Street address
Chamran Boulevard, 1th Abivardi street
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellery of Research affairs of Shiraz University of Medical Sciences
Full name of responsible person
DR. Dabaghmanesh
Street address
Karimkhan Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellery of Research affairs of Shiraz 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
School of rehabilitation
Full name of responsible person
Ali Ghanbari
Position
ph.D Physiotherapy
Other areas of specialty/work
Street address
Chamran Boulevard- Abiverdi 1
City
Shiraz
Postal code
7194733669
Phone
+98 71 1627 1551
Fax
+98 71 1627 2495
Email
ghanbary@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Rehabilitation
Full name of responsible person
Ali Ghanbari
Position
ph.D- Physiotherapy
Other areas of specialty/work
Street address
Chamran Boulevard - Abiverdi 1
City
Shiraz
Postal code
7194733669
Phone
+98 71 1627 1551
Fax
+98 71 1627 2495
Email
ghanbary@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Rehabilitation
Full name of responsible person
Ali Ghanbari
Position
Ph.D- Physiotherapy
Other areas of specialty/work
Street address
Shiraz- Chamran Boulevard - Abiverdi 1
City
Shiraz
Postal code
7194733669
Phone
+98 71 1627 1551
Fax
+98 71 1627 2495
Email
ghanbary@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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