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Trial registered on ANZCTR


Registration number
ACTRN12611001010987
Ethics application status
Approved
Date submitted
20/09/2011
Date registered
21/09/2011
Date last updated
21/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of lumbar extension traction on sagittal alignment in mechanical low back pain: A randomized trial
Scientific title
The effect of lumbar extension traction in addition to stretching exercises and infrared radiation on sagittal balance parameters and pain in chronic low back pain patients
Secondary ID [1] 263085 0
nil
Universal Trial Number (UTN)
U1111-1124-6440
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mechanical low back pain 270837 0
Condition category
Condition code
Musculoskeletal 271005 271005 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study 3-point bending traction was used, each subject lied in a supine position; an anterior pull was applied by a posterior padded strap between the upper torso and lower pelvis, which placed under the patient's low back, at the level of lumbar curve. The tension in the strap was the transverse force (part 1 of 3-point bending) and was adjusted to each patient's tolerance, this strap was connected to computerized traction unit. whereas the second strap at the level of the femur heads (part 2 of 3-point bending) constrained the femurs to permit increased forward rotation of the pelvis and the third strap placed at the upper torso (part 3 of 3-point bending). The patints were having traction three times a week for ten weeks. The traction began at three minutes/session, increased one minute/session to 20minutes, at which time traction was applied for 20minutes/session. After they became familiar with the traction, patients were encouraged to use the maximum tolerable force.


Stretching exercises were performed for erector spine muscles and hamstring muscle holding each movement for 30 seconds. Each exercise was repeated 3 times. The stretching program was performed 3 times a week for 10 weeks.

Application of infrared radiation (wave length 800-1000nm). The patient was assumed the prone lying position where the area to be treated (the paraspinal muscles of the back) was adequately exposed, supported and relaxed. The lamp was positioned at distance ranged from (50-75cm). The radiation strikes the surface at or near right angle to achieve maximum penetration. The duration of application was fifteen minutes per session 3 times a week for 10 weeks. The Visual Analog Scale (VAS) was used to assess each patient’s pain perception.

all treatments were administered simultaneously over the10 weeks.
Intervention code [1] 269428 0
Rehabilitation
Intervention code [2] 269434 0
Treatment: Devices
Comparator / control treatment
The control group received stretching exercises and infrared radiation, the same as that administered to the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 279677 0
radiographs taken and assessed digitally using surgimap software to measure sagittal balance parameters in terms of lumbar lordosis, thoracic kyphosis, sacral slope, and positioning of C7 plumb line.
Timepoint [1] 279677 0
before treatment, 10 weeks afterwards and at 6 months follow up.
Secondary outcome [1] 294171 0
The Visual Analog Scale (VAS) was used to assess each patient?s pain perception
Timepoint [1] 294171 0
before treatment, 10 weeks afterwards and at 6 months follow up.

Eligibility
Key inclusion criteria
1-patients with chronic mechanical low back pain. Duration of symptoms more than 3 months to avoid acute stage of inflammation
2-with defined lumbar hypo-lordosis, lumbar lordosis measured less than 40 degrees.
Minimum age
40 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
spinal canal stenosis, rheumatoid arthritis, osteoporosis, inability to tolerate lumbar extension position, scoliotic deformity and any deformity of lower extremity that may interfere with global alignment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patients were randomly assigned into two groups using the roll of a dice, an experimental group (odd number) and a control group (even number). Random permuted blocks of fixed size were employed to achieve a balance of the sample sizes between the two groups. A resident who was blinded to the research protocol and was not otherwise involved in the trial operated the random assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The patients were randomly assigned into two groups using the roll of a dice, an experimental group (odd number) and a control group (even number).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
study group and control group
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3854 0
Egypt
State/province [1] 3854 0

Funding & Sponsors
Funding source category [1] 269901 0
Self funded/Unfunded
Name [1] 269901 0
Aliaa Attiah Diab
Address [1] 269901 0
Faculty of Physical Therapy, cairo university, Egypt

7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt.

Postal Code: 12612
Country [1] 269901 0
Egypt
Primary sponsor type
Individual
Name
Aliaa Attiah Diab
Address
Faculty of Physical Therapy, cairo university, Egypt

7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt.

Postal Code: 12612
Country
Egypt
Secondary sponsor category [1] 268912 0
None
Name [1] 268912 0
Address [1] 268912 0
Country [1] 268912 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271872 0
faculty counsel for post graduated study and researcher
Ethics committee address [1] 271872 0
Faculty of Physical Therapy - Cairo University
7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt.

Postal Code: 12612
Ethics committee country [1] 271872 0
Egypt
Date submitted for ethics approval [1] 271872 0
Approval date [1] 271872 0
03/11/2008
Ethics approval number [1] 271872 0

Summary
Brief summary
This study was conducted to investigate the effect of lumbar extension traction on pain and whole spine sagittal balance as represented in lumbar curvature, thoracic curvature, C7 plumb line, and sacral slope.

Eighty patients with chronic mechanical low back pain (CMLBP) with definite hypolordosis were randomly assigned to traction or a control group. The control group (n=40) received stretching exercises and infrared radiation, whereas the traction group (n=40) received lumbar extension traction in addition to stretching exercises and infrared radiation.Main outcome measures: sagittal balance parameters in terms of lumbar lordosis, thoracic kyphosis, sacral slope, and positioning of C7 plumb line were measured for all patients at three intervals (before treatment, after 10 weeks of treatment, and at follow-up of six months).

Results: all sagittal balance variables did not change in the control groups (p>0.05) .In the study group, the paired t test revealed a significant change in all sagittal balance variables in study group (p=0.000), while the control group revealed insignificant changes for all the previous variables. For Pain variable, the paired t test revealed a significant decrease in the pain level for both groups (p=0.000), while the unpaired t test revealed a significant difference between post treatment values for all previous measured variables between both groups (p=0.001).At 6-months follow-up, there were significant differences between both groups for all the previous variables (p>0.05).
Conclusions: Lumbar extension traction in addition to stretching exercises and infrared radiation is beneficial in improving the pain and sagittal balance parameters in CMLBP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33185 0
Address 33185 0
Country 33185 0
Phone 33185 0
Fax 33185 0
Email 33185 0
Contact person for public queries
Name 16432 0
Aliaa Attiah Diab
Address 16432 0
faculty of physical therapy- Cairo university
7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country 16432 0
Egypt
Phone 16432 0
+20103627375
Fax 16432 0
Email 16432 0
Ola_1174@hotmail.com
Contact person for scientific queries
Name 7360 0
Aliaa Attiah Diab
Address 7360 0
faculty of physical therapy- Cairo university
7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country 7360 0
Egypt
Phone 7360 0
+20103627375
Fax 7360 0
Email 7360 0
Ola_1174@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary