Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000311853
Ethics application status
Approved
Date submitted
15/03/2012
Date registered
20/03/2012
Date last updated
20/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of lumbar lordosis rehabilitation in patients with discogenic lumbosacral radiculopathy: A randomized trial
Scientific title
The effect of lumbar extension traction in addition to hot packs and interferential therapy on lumbar lordotic angle, disability, back and leg pain, lumbar flexibility, mechanical findings,and neurophysiogical findings in patients with discogenic lumbosacral radiculopathy.
Secondary ID [1] 280161 0
nil
Universal Trial Number (UTN)
U1111-1129-1261
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
discogenic lumbosacral radiculopathy 286064 0
Condition category
Condition code
Musculoskeletal 286257 286257 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 286259 286259 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients received hot packs ( hydrocollator). A hydrocollator pack is a silica gel filled pack that is soaked in hot water for a minimum of 20 minutes. The gel pack is wrapped in towels 3 to 5 layers underneath and 1 on top to provide prolonged moist heat.
During application, patients were asked to adopt prone position the hot packs was applied on the lumbosacral region for 15 minutes.This conventional treatment was to be repeated three times per week for 10 weeks.

interferential therapy. During interferential application, patients were asked to adopt prone position. Interferential treatment was introduced using electrotherapy device. The interferential therapy was delivered at the lumbosacral region with an amplitude-modulated constant frequency of 100 Hz and a pulse duration of 125 micro seconds due to its analgesic effect, for a 20-minutes.This conventional treatment was to be repeated three times per week for 10 weeks.

The patients additionally received lumbar extension traction. In this type of traction, 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

all treatments were administered simultaneously over the10 weeks.
Intervention code [1] 284471 0
Treatment: Devices
Intervention code [2] 284472 0
Rehabilitation
Comparator / control treatment
The control group received hot packs and interferential therapy, the same as that administered to the intervention group. the control group did not received lumbar extension traction.
Control group
Active

Outcomes
Primary outcome [1] 286724 0
the lumbar lordotic angle.it was measured from lateral radiograph by calculating the ARA which considered as a valid and reliable measurement. From lateral radiograph, the posterior superior and posterior inferior vertebral body corners of L1 and L5on lateral lumbar radiograph were marked. The absolute rotatory angle formed by the intersection between posterior vertebral body tangent lines of L1 and L5.
Timepoint [1] 286724 0
pre treatment, 10 weeks post treatment, and at six months of follow up
Secondary outcome [1] 296537 0
disability
Disability was measured using the Oswestry Disability Index. It consists of 10 items that refer to activities of daily living that might be disrupted by low back pain. The items are: 1. pain intensity, 2. personal care, 3. lifting, 4. walking, 5. sitting, 6. standing, 7. sleeping, 8. sex life, 9. social life, and 10. traveling. Each with 1 of 6 possible answers provided. The total score is transferred onto a scale ranging from 0 to 100, where 0 indicates no disability and 100 indicates worst possible disability
Timepoint [1] 296537 0
pre treatment, 10 weeks post treatment, and at six months of follow up
Secondary outcome [2] 296538 0
symptoms (back and leg pain)
pain were measured by The Numerical Pain Rating Scale (NPRS) which considered as a valid and reliable scale was used to measure the patient pain intensity.The scale is composed of 0-10numbers. The Patients were asked to place a mark along the line to denote their level of pain; 0 reflecting no pain and 10 reflecting the worst pain.
Timepoint [2] 296538 0
pre treatment, 10 weeks post treatment, and at six months of follow up
Secondary outcome [3] 296539 0
lumbar flexibility assessment,
the modified Schober test was used in this study. A skin mark was drawn at the level of the lumbosacral junction and another two marks were drawn 10cm above and 5 cm below this first mark. Participants maximally bent their trunk without bending the knees, at which time the distance between upper and lower marks was measured in centimeters. The mean of three trials was used for data analysis. Intrarater reliability for this testis high (r=0.88).
Timepoint [3] 296539 0
pre treatment, 10 weeks post treatment, and at six months of follow up
Secondary outcome [4] 296540 0
neurophysiogical findings (latency and peak to peak amplitude of H reflex).
Latency and peak to peak amplitude of H reflex was measured. An electromyogram device (Tonneis neuroscreen plus version 1.59, Germany). The patient was lying prone on a wooden padded table, with arms on the side. The head was maintained in mid position to eliminate the possible effects of asymmetrical tonic neck reflex. The knee was flexed 20 degrees by placing a small cushion under the knee to relax the gastrocnemius muscle. The feet were allowed to rest free over the edge of the bed, with the ankle joints in an anatomically neutral position. Then, the skin of the popliteal fossa, calf muscle and soleus muscle of both legs was rubbed lightly with fine grade sandpaper and finally cleaned with a piece of cotton soaked with alcohol. A silver -silver chloride surface-stimulating bar electrode with coupling gel was placed longitudinally on the tibial nerve in the popliteal fossa midline with the cathode proximal to the anode. A recording surface bar electrode was positioned over the soleus muscle with the active electrode proximal to the reference electrode, and 3 cm distal to the bifurcation of the gastrocnemii and on the line with the Achilles tendon. A ground surface metal electrode was positioned midway between the stimulation and recording electrodes to minimize the stimulus artifact. Electrodes were firmly secured with adhesive tape. The stimulation parameters were 1.0 ms pulse duration and intensity that elicited H-maximum with minimum and stable M-response at a frequency of 0.2 Hz. Two-minute practice trials of elicited H-reflex were obtained to familiarize the patients with the H-reflex stimulation and recordings. Four readings of the maximum H-reflex with minimum and stable M-response were recorded and averaged from the involved leg. The signals were amplified 500-2000 using differential amplification and filtered at 20-10,000 Hz bandwidth, digitized and stored on computer for analysis
Timepoint [4] 296540 0
pre treatment, 10 weeks post treatment, and at six months of follow up
Secondary outcome [5] 296541 0
mechanical findings (segmental intervertebral movements), three sets of lateral lumbar radiograph in flexion and extension view were analyzed. 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 are 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
Timepoint [5] 296541 0
pre treatment, 10 weeks post treatment, and at six months of follow up

Eligibility
Key inclusion criteria
patients with absolute rotatory angle was less than 39 degrees. then a participant was referred to the study. patients had a confirmed chronic unilateral lumbosacral radiculopathy associated with L5-S1 lumbar disc prolapse , and duration of symptoms more than 3 months to avoid acute stage of inflammation. Patients underwent magnetic resonance (MR) imaging, which detected disc lesion corresponding to the S1 nerve root. All patients had unilateral leg pain with mild to moderate disability according to ODI (up to 40%). They all had side-to-side H reflex latency differences of more than 1msec.
Minimum age
40 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
included previous history of lumbosacral surgery, metabolic system disorder, cancer, cardiac problems, peripheral neuropathy or history of upper motor neuron lesion, spinal canal stenosis, rheumatoid arthritis, osteoprosis, inability to tolerate lumbar extension position, spondylolisthesis , 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)
patients were randomly assigned into two groups of equal number by an independent person who picked one of the sealed envelopes which contained numbers chosen by random number generator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
patients were randomly assigned into two groups by an independent person who picked one of the sealed envelopes which contained numbers chosen by random number generator .Randomization was restricted to permuted blocks to ensure equal numbers being allocated to each group. Each random permuted block was transferred to a sequence of consecutively numbered, sealed, opaque envelopes and these were stored in a locked drawer until required. As each participant formally entered the trial, the researcher opened the next envelope in the sequence in the presence of the patient.
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
7/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment outside Australia
Country [1] 4203 0
Egypt
State/province [1] 4203 0

Funding & Sponsors
Funding source category [1] 284888 0
Self funded/Unfunded
Name [1] 284888 0
Ibrahim Moustafa Moustafa
Country [1] 284888 0
Egypt
Primary sponsor type
Individual
Name
Ibrahim Moustafa Moustafa
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] 283768 0
Individual
Name [1] 283768 0
Aliaa Attiah Diab
Address [1] 283768 0
Address: Faculty of Physical Therapy, cairo university, Egypt

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

Postal Code: 12612
Country [1] 283768 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286885 0
faculty counsel for post graduated study and researcher
Ethics committee address [1] 286885 0
Faculty of Physical Therapy - Cairo University
7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt.

Postal Code: 12612
Ethics committee country [1] 286885 0
Egypt
Date submitted for ethics approval [1] 286885 0
Approval date [1] 286885 0
11/04/2009
Ethics approval number [1] 286885 0

Summary
Brief summary
this study was conducted to investigate the effects of lumbar extension traction in patients with unilateral lumbosacral radiculopathy due to L5-S1 disc herniation.
Sixty four patients with confirmed unilateral lumbosacral radiculopathy due to L5-S1 disc herniation and lumbar lordotic angle measured less 39 degrees were randomly assigned to traction or a control group.The control group (n=32) received hot packs and interferential therapy, whereas the traction group (n=32) received lumbar extension traction in addition to hot packs and interferential therapy. Absolute rotatory angle (ARA), back and leg pain rating scale, Oswestry Disability Index, modified Schober test, H reflex (latency and amplitude) and intervertebral movements were measured for all patients at three intervals (before treatment, after 10 weeks of treatment, and at follow-up of six months). There was a significant difference between the traction and control groups adjusted to baseline value of outcome for all measured variables at 10 weeks post treatment with respect to ARA (P=0.000), ODI ( P=0.002), back and leg pain (P=0.009), (P=0.005), modified Schober test (p=0.002), latency and amplitude of H reflex(p=0.01), ( p=0.000), intervertebral movements (p>0.05) and at follow-up for all previous variables (p>0.05). Lumbar extension traction in addition to hot packs and interferential therapy decreased pain, disability and H reflex latency while increased lumbar flexibility, H reflex amplitude, and segmental intervertebral movements



100 patients were initially screened.After the screening process, 68 patients were eligible to participate in the study. patients registered but Not randomized (n=4)
Due to early discharge for non -medical reasons
and Total number of patients registered (n=64)
randomization.
Patients in both the experimental (n=32) and the control group (n=32)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33922 0
Address 33922 0
Country 33922 0
Phone 33922 0
Fax 33922 0
Email 33922 0
Contact person for public queries
Name 17169 0
Ibrahim Moustafa Moustafa
Address 17169 0
faculty of physical therapy- Cairo university
7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country: Egypt
Country 17169 0
Egypt
Phone 17169 0
+201227022334
Fax 17169 0
Email 17169 0
hema_pt76@yahoo.com
Contact person for scientific queries
Name 8097 0
Ibrahim Moustafa Moustafa
Address 8097 0
faculty of physical therapy- Cairo university
7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country: Egypt
Country 8097 0
Egypt
Phone 8097 0
+201227022334
Fax 8097 0
Email 8097 0
hema_pt76@yahoo.com

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

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