Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000030875
Ethics application status
Approved
Date submitted
23/12/2011
Date registered
9/01/2012
Date last updated
9/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of lumbar lordosis rehabilitation on pain and lumbar segmental motion in chronic mechanical low-back pain: A randomized trial
Scientific title
The effect of lumbar extension traction in addition to stretching exercises and infrared radiation on segmental motion and pain in chronic low back pain patients
Secondary ID [1] 279644 0
nil
Universal Trial Number (UTN)
U1111-1126-6557
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mechanical low back pain 285442 0
Condition category
Condition code
Musculoskeletal 285627 285627 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 285660 285660 0 0
Physiotherapy

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;, there is vertical load applied by a posterior padded strap between the upper torso and lower pelvis while the upper torso and femur were stabilized by other straps. The patients 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
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] 283928 0
Treatment: Devices
Intervention code [2] 283949 0
Rehabilitation
Intervention code [3] 283950 0
Treatment: Other
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] 286185 0
for absolute rotatory angle measurement
The posterior superior and posterior inferior vertebral body corners of L12 and S1on lateral lumbar radiograph were marked.The absolute rotatory angle formed by the intersection between posterior vertebral body tangent lines of T12 and S1.
Timepoint [1] 286185 0
pre treatment, 10 weeks post treatment, and at three months of follow up
Primary outcome [2] 286186 0
For kinematic data acquisition of lumbar spine:Three sets of lateral lumbar radiograph in flexion and extension view were analyzed according to protocol of Frobin et al (1996). For measuring the sagittal rotational movements between segments L1-L2: L5-S1, we started by defining the midplane which is the line connecting the midpoints between corners for each vertebrae and then the angle between two adjacent vertebrae is calculated by the angle between their midplanes. The value of sagittal rotational motion of any segment is given by the difference of the angle in extension view minus the angle in flexion view .For translational displacements measurement between each adjacent vertebra , we had to draw Perpendiculars from the center points which is the geometric center of four corners onto the bisectrix between the midplane. The difference between the intersection points in the bisectrix line was defined as translational displacement. To correct the radiographic magnification, the displacement measured in millimeters was divided by the mean depth of the caudal vertebra. As previous, the value of translational motion is given by the difference of the displacement in extension view minus the displacement in flexion view.

(Frobin W, Brinckmann P. Leivseth G, Biggemann M, Reikeras O. Precision measurement of segmental motion from flexion-extension radiographs of the lumbar spine. ClinBiomech (Bristol, Avon) 1996; 11: 457-465.)
Timepoint [2] 286186 0
Pre treatment, 10 weeks post treatment, and at three months of follow up
Primary outcome [3] 286187 0
For pain assessment
It was performed by using VAS, the patients were asked about the perception of pain using a 10 cm line with 0 (no pain) on one end and 10 (worst pain) on the other end. Patients were asked to place a mark along the line to denote their level of pain.
Timepoint [3] 286187 0
Pre treatment, 10 weeks post treatment, and at three months of follow up
Secondary outcome [1] 295331 0
nil
Timepoint [1] 295331 0
nil

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 lumbar lordosis measured less than 40 degrees.
Minimum age
40 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
lumbar spondylotic radiculopathy, lumbar disc. Spinal canal stenosis, rheumatoid arthritis, osteoprosis, 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
3/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 4030 0
Egypt
State/province [1] 4030 0

Funding & Sponsors
Funding source category [1] 284421 0
Self funded/Unfunded
Name [1] 284421 0
Ibrahim Moustafa Moustafa
Country [1] 284421 0
Egypt
Primary sponsor type
Individual
Name
Aliaa Attiah Diab
Address
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] 283349 0
Individual
Name [1] 283349 0
Ibrahim Moustafa Moustafa
Address [1] 283349 0
Address: Faculty of Physical Therapy, cairo university, Egypt

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

Postal Code: 12612
Country [1] 283349 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286396 0
faculty counsel for post graduated study and researcher
Ethics committee address [1] 286396 0
Ethics committee country [1] 286396 0
Egypt
Date submitted for ethics approval [1] 286396 0
Approval date [1] 286396 0
17/08/2009
Ethics approval number [1] 286396 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33563 0
Address 33563 0
Country 33563 0
Phone 33563 0
Fax 33563 0
Email 33563 0
Contact person for public queries
Name 16810 0
Ibrahim Moustafa Moustafa
Address 16810 0
faculty of physical therapy- Cairo university
7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country 16810 0
Egypt
Phone 16810 0
+201227022334
Fax 16810 0
Email 16810 0
[email protected]
Contact person for scientific queries
Name 7738 0
Aliaa Attiah Diab
Address 7738 0
faculty of physical therapy- Cairo university
7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country 7738 0
Egypt
Phone 7738 0
+201003627375
Fax 7738 0
Email 7738 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.