Protocol summary

Summary
Objective: To investigate the effect of lumbar and sacroiliac joint (SIJ) manipulation on pain and functional disability in patients with lumbar disc herniation (LDH) concomitant with SIJ hypomobility Methods: Twenty subjects with LDH suffering from SIJ hypomobility will receive five sessions of spinal manipulative therapy (SMT) to the SIJ and lumbar spine through two weeks. Back and leg pain intensity and functional disability level will be assessed by Numerical Rating Scale (NRS) and Oswestry Disability Index (ODI), at baseline, immediately after, 3rd and 5th session and one month after the treatment. Inclusion criteria: Age between 20 and 50 years old; MRI-proven unilateral lumbar disc herniation; Symptomatic lumbar disc disease at one segment( L4-L5 or L5-S1); Ipsilateral sacroiliac joint hypomobility; Leg pain during one to 10 months before the study; Leg pain over previous 24 hours should be 30-70 out of 100 Exclusion criteria: Sequestrated lumbar disc herniation; Spinal canal stenosis; Spondylolysthesis; Previous lumbar surgery; Gross instability; Positive SLR test

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011924149N33
Registration date: 2017-02-19, 1395/12/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-19, 1395/12/01
Registrant information
Name
Fahimeh Kamali
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
kamalif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-01-21, 1388/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Spinal manipulation in the treatment of patients with MRI-confirmed lumbar disc herniation who had sacroiliac joint hypomobility: a quasi-experimental study
Public title
Spinal manipulation in the treatment of patients with lumbar disc herniation who had sacroiliac joint hypomobility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 20 and 50 years old; MRI-proven unilateral lumbar disc herniation; Symptomatic lumbar disc disease at one segment( L4-L5 or L5-S1); Ipsilateral sacroiliac joint hypomobility; Leg pain during one to 10 months before the study; Leg pain over previous 24 hours should be 30-70 out of 100 Exclusion criteria: Sequestrated lumbar disc herniation; Spinal canal stenosis; Spondylolysthesis; Previous lumbar surgery; Gross instability; Positive SLR test
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
None
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Vice-Chancellery for Research Office, Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Blvd, Shiraz
City
Shiraz
Country
Iran (Islamic Republic of)
Postal code
Approval date
2009-08-03, 1388/05/12
Ethics committee reference number
CT-88-4614

Health conditions studied

1

Description of health condition studied
lumbar disc herniation
ICD-10 code
M51.2
ICD-10 code description
Other specified intervertebral disc displacement

Primary outcomes

1

Description
Pain intensity
Timepoint
Before, Immediately, 3rd session, 5th session and a month after intervention
Method of measurement
VAS

2

Description
Disability level
Timepoint
Before, 3rd session, 5th session and a month after intervention
Method of measurement
Oswestry pain and disability questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: five sessions of lumbar rotational and sacroiliac joint manipulation, every other day
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Rehabilitation Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Esmaeil Shokri
Street address
Abiverdi St.و Chamran Blvd.
City
Shiraz
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellery for Research Affairs, Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Central Building of Shiraz University of Medical Sciences, Zand Blvd., Shiraz
City
Shiraz
Country
Iran (Islamic Republic of)
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery for Research Affairs, 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 Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Kamali
Position
Associate Professor
Other areas of specialty/work
Street address
Abiverdi St., Chamran Blvd., Shiraz
City
Shiraz
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 71 3627 1551
Fax
Email
kamalif@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Rehabilitation Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Kamali
Position
Associate Professor
Other areas of specialty/work
Street address
Abiverdi St., Chamran Blvd., Shiraz
City
Shiraz
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 71 3627 1551
Fax
Email
kamalif@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Rehabilitation Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Kamali
Position
Associate Professor
Other areas of specialty/work
Street address
Abiverdi St., Chamran Blvd., Shiraz
City
Shiraz
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 71 3627 1551
Fax
Email
kamalif@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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