Objective: The comparison of the effects of two compounded treatments-traction and stabilization exercises versus manipulation and stabilization exercises-on pain and functional improvement in patients with lumbar disc herniation. Design: containing 40 patients with sub-acute or chronic lumbar disc herniation that referred to Shiraz University of medical science physical therapy clinics that randomized by "research randomizer" program into 2 practical groups with 20 participants in each group, single blinded, parallel. Setting and conduct: including 5 visits of manipulation in first group and 5 visits of traction in second group, then 12 visits of core stabilization exercises in both groups. Participants: Inclusion criteria includes: sub-acute or chronic phase of lumbar disc herniation; disc herniation in L4-L5 or L5-S1 levels unilaterally, Exclusion criteria includes: surgery of lumbar region; degenerative joint diseases in lumbar region. Intervention: The first group patients treated with high-velocity low-amplitude spinal manipulation to the sacroiliac joint and lumbar spine for five sessions through ten days and The second group patients treated with motorized lumbar traction for five sessions through ten days, then both group treated by twelve sessions of unsupervised core stability exercise through six week (two sessions per week) in the same situations. Main outcome measures: outcomes were assessed using visual analogue scale for lumbar and leg pain separately and Oswestry Disability Questionnaire for functional disability at baseline, after 5 sessions of treatment (manipulation or traction) and after finishing of core stabilization exercise period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406249440N7
Registration date:2015-08-05, 1394/05/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-05, 1394/05/14
Registrant information
Name
Soraya Pirouzi
Name of organization / entity
School of Rehabilitation Sciences, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 5108
Email address
piroozis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2013-12-10, 1392/09/19
Expected recruitment end date
2015-04-15, 1394/01/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effects of two compounded treatment on pain and functional improvement in patients with lumbar disc herniation
Public title
The comparison of the effects of two physiotherapy compounded treatments on improvement of lumbar disc herniation symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria for both group: sub-acute or chronic phase of lumbar disc herniation; disc herniation in L4-L5 or L5-S1 levels unilaterally and by CT-Scan or M.R.I confirmed; symptoms period between 1-12 month(s); leg pain domination versus lumbar pain; pain-free barrier in manipulation.
Exclusion criteria for both groups: sequestration of herniated disc; surgery of lumbar region; degenerative joint diseases in lumbar region; progressive neurological symptoms; sphincter dysfunction; cauda equina syndrome; lumbar Spondylolisthesis; spinal canal stenosis; spinal tumors
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
participants randomized by "research randomizer" program into 2 practical groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Vice chancellor for research and Technology, Shiraz University of Medical Science
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Postal code
7194733669
Approval date
2013-08-10, 1392/05/19
Ethics committee reference number
CT-92-6927
Health conditions studied
1
Description of health condition studied
M51.1
ICD-10 code
Lumbar and
ICD-10 code description
Primary outcomes
1
Description
lumbar pain
Timepoint
before intervention, after 5 sessions of manipulation or traction, after intervention
Method of measurement
visual analog scale (100 degree)
2
Description
leg radicular pain
Timepoint
before intervention, after 5 sessions of manipulation or traction, after intervention
Method of measurement
visual analog scale (100 degree)
3
Description
disability
Timepoint
before intervention, after 5 sessions of manipulation or traction, after intervention
Method of measurement
Oswestry Disability Questionnaire (ODQ)
Secondary outcomes
empty
Intervention groups
1
Description
first group intervention: high-velocity low-amplitude spinal manipulation to the sacro-iliac joint and lumbar spine for five sessions through ten days, then twelve sessions of unsupervised core stability exercise through six weeks
Category
Rehabilitation
2
Description
second group intervention: motorized lumbar traction for five sessions through ten days, then twelve sessions of unsupervised core stability exercise through six weeks
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Dr Soraya Pirouzi
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology, Shiraz University of Medical Sciences
Full name of responsible person
Dr Poostforoosh
Street address
Chancellery of Research and Technology, Level 7, Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and technology, 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
Dr. Soraya Pirouzi
Position
Professor Assistance
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Chamran Blv, Abivardi St
City
Shiraz
Postal code
7194733669
Phone
+98 71 3626 5108
Fax
Email
piroozis@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
Dr Soraya Pirouzi
Position
Professor assistant
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Abiverdi St, Chamran Blv
City
Shiraz
Postal code
7194733669
Phone
+98 71 3626 5108
Fax
Email
piroozis@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
Dr Soraya Pirouzi
Position
Professor Assistance
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Chamran Blv, Abivardi St
City
Shiraz
Postal code
7194733669
Phone
+98 71 3626 5108
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)