Objectives: the aim of our study is to evaluate effect of manual therapy on pain and disability of patients with imaging proven herniated lumbar disc and concomitant sacroiliac joint dysfunction.
Methods: following randomized selection of 47 subjects, more than or equal to 18 years with image proven herniated lumbar disc and physical findings of concomitant SIJD (Sacroiliac Joint Dysfunction), routine physical or manual therapy would be applied to two separated groups. For all of patients, electrodiagnostic evaluation prior to beginning of therapy, and VAS, Margolis pain drawing and Oswestry functional disability scoring at three times, before starting of 1st (baseline), 3rd and 6th therapy sessions will done. The data were statistically analyzed using t-test and ANOVA statistical methods. SPSS 11.5 software will be used for statistical analysis of findings.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110719839N1
Registration date:2016-02-23, 1394/12/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-23, 1394/12/04
Registrant information
Name
Seyed Pezhman Madani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 9331
Email address
madani.p@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2010-12-31, 1389/10/10
Expected recruitment end date
2013-12-31, 1392/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Manual Therapy on Pain and Disability of Patients with Imaging Proven Herniated Lumbar Disc and Concomitant Sacroiliac Joint Dysfunction
Public title
Effect of Manual Therapy on Pain and Disability of Patients with Imaging Proven Herniated Lumbar Disc and Concomitant Sacroiliac Joint Dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
We include the subjects with age ≥18 years old; both male and female provided paracentral or intraforaminal herniated lumbar discs on magnetic resonance imaging (MRI) and physical exam results indicative of lumbosacral root irritation concomitant with SIJ dysfunction.
Patients with positive history of lumbar spine surgery, spinal or hip fractures, osteoporosis, severe hip joint degenerative disorders, diabetes mellitus and polyneuropathy, progressive neurological deficit signs owing to discopathy, relative contraindication for electrodiagnostic exam or manual therapy also all of subjects had current pregnancy or unfinished extensive physical examination for any reason, would be excluded.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
47
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Postal code
Approval date
2001-08-20, 1380/05/29
Ethics committee reference number
496
Health conditions studied
1
Description of health condition studied
Sacroiliac joint dysfunction
ICD-10 code
M 54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain
Timepoint
At the beginning and 6th session
Method of measurement
VAS
Secondary outcomes
1
Description
disability
Timepoint
at the beggining and 6 wks
Method of measurement
oswestry questionnaire
2
Description
Pain area
Timepoint
At the beginning and 6th session
Method of measurement
Margolis
Intervention groups
1
Description
Manual therapy techniques in case group
Category
Rehabilitation
2
Description
Routin physical theray modalities such as heat and electrotherapy in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Yahyaian Rehabilitation Hospital
Full name of responsible person
Seyyed Pezhman Madani
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mrs. Kordloo
Street address
Research Office, Iran University of Medical Sciences, 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
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
Seyed Pezhman Madani
Position
Assistant professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Postal code
Phone
+98 21 8896 9331
Fax
Email
madani.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
Seyed Pezhman Madani
Position
Assistant professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Postal code
Phone
+98 21 8896 9331
Fax
Email
madani.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
Seyed Pezhman Madani
Position
Assistant professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Postal code
1437735634
Phone
+98 21 8896 9331
Fax
+98 21 8896 9331
Email
madani.p@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)