Objectives: Effect of repeated lumbar traction by a door-mounted pull-up bar at home on herniated lumbar disc and reduction of imposed expenses by physiotherapy
Design: Prospective randomized controlled trial
Setting and Conduct: 50 patients are included in the study according to the following criteria and then are separated into two groups, traction and the control group and the interventions are undertaken.
Participants: Patients of K & B province referring to Yasuj Shahid Mofateh clinic due to disc herniation with the following criteria.
Inclusion criteria:
low back pain or sciatica due to lumbar disc herniation and L3-S1 radiculopathy; duration of pain less than 6 months; lumbar disc herniation verified by MRI; consistency in the pattern of pain complaint, neurological, and radiological findings; no history of previous physical therapy in the past; willing to take part in the study by signing a written informed consent.
Exclusion criteria:
low back pain due to neoplastic, inflammatory, infectious, or metabolic causes; indication of urgent surgery; spinal stenosis; pregnancy, postpartum period, and postoperative 3 months; previous vertebral surgery; LBP more than 6 months duration; gross structural abnormalities of vertebrae like listhesis; severe degenerative changes of spine; and intolerance of physical activity
Interventions: In the traction group traction by suspension from a pull-up bar is assigned in addition to the routine LBP medication for 2 months (25 times a day each time 40 sec). In the control group only the routine medications are prescribed for 2 months.
Main variables: Two variables are evaluated. One of them is the size of herniated material measured by a specific index called "Herniation Index" by a "blind" examiner (radiologist), and the other one is VAS for evaluation of pain intensity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012120311654N1
Registration date:2013-02-27, 1391/12/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-27, 1391/12/09
Registrant information
Name
Mehdi khani
Name of organization / entity
Yasuj university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 1223 1039
Email address
drmkhani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Yasuj university of medical sciences
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of repeated lumbar traction by a door-mounted pull-up bar at home on the size and symptoms of herniated lumbar disc
Public title
Effect of pull-up bar exercise on disc herniation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: low back pain or sciatica due to lumbar disc herniation and L3-S1 radiculopathy; duration of pain less than 6 months; lumbar disc herniation verified by MRI; consistency in the pattern of pain complaint, neurological, and radiological findings; no history of previous physical therapy in the past; willing to take part in the study by signing a written informed consent. Exclusion criteria: low back pain due to neoplastic, inflammatory, infectious, or metabolic causes; indication of urgent surgery; spinal stenosis; pregnancy, postpartum period, and postoperative 3 months; previous vertebral surgery; gross structural abnormalities (e.g. spondylolisthesis); being unable to tolerate physical exercise due to cardiovascular reasons; presence of significant degenerative changes in lumbosacral vertebrae on X-rays; and duration of low back pain of more than 6 months.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Yasuj medical school Ethics committee for research
Street address
Yasuj university of medical sciences, Motahari avenue, Yasuj
City
Yasuj
Postal code
Approval date
2011-11-21, 1390/08/30
Ethics committee reference number
90/8/30/4
Health conditions studied
1
Description of health condition studied
Lumbar disc herniation
ICD-10 code
M51.2
ICD-10 code description
Lumbago due to displacement of intervertebral disc
Primary outcomes
1
Description
size of herniated disc material
Timepoint
before intervention- 2 months after intervention
Method of measurement
Herniation Index
2
Description
pain intensity
Timepoint
Before intervention- 2 months after intervention
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
50 patients who have the mentioned criteria will be admitted to the study with their signed consent. They are randomly divided in to two groups: the traction group and the control group. The traction group includes 25 patients and they are given a program of repeated lumbar traction by suspension from a pull up bar for 2 months (at least 25 times a day each time for 40 seconds) plus routine medication for disc herniation.
Category
Treatment - Other
2
Description
The control group includes 25 patients and they are given the routine medication (NSAID, Corticosteroids, Antispasmodics) without traction for a duration of 2 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofateh clinic
Full name of responsible person
Mehdi Khani
Street address
Montazeri avenue, Yasuj
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Yasuj university of medical sciences
Full name of responsible person
Mr Negintaji
Street address
Vice Chancellor for Research, Yasuj university of medical sciences, Motahari avenue, Yasuj
City
Yasuj
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, Yasuj 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
Yasuj university of medical sciences
Full name of responsible person
Mehdi Khani
Position
neurosurgeon
Other areas of specialty/work
Street address
Mr Niknam's house, Sardar 2 alley, Montazeri st.
City
Yasuj
Postal code
Phone
+98 74 1223 1039
Fax
Email
drmkhani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj university of medical sciences
Full name of responsible person
Mehdi Khani
Position
Neurosurgeon
Other areas of specialty/work
Street address
Mr Niknam's house, Sardar 2 alley, Montazeri st.
City
Yasuj
Postal code
Phone
+98 74 1223 1039
Fax
Email
drmkhani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj university of medical sciences
Full name of responsible person
Mehdi Khani
Position
neurosurgeon
Other areas of specialty/work
Street address
Mr Niknam's house, Sardar 2 alley, Montazeri st.
City
Yasuj
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)