Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000169741
Ethics application status
Approved
Date submitted
7/02/2013
Date registered
12/02/2013
Date last updated
12/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cervical radiculopathy: A new traction method versus ventroflexion traction :A randomized controlled 1-year follow-up study
Scientific title
the efficacy of two different traction methods in addition to conventional treatment on nerve root function, pain, and disability in patients with discogenic cervical radiculopathy
Secondary ID [1] 281913 0
Nil
Universal Trial Number (UTN)
U1111-1139-3107
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical radiculopathy 288310 0
Condition category
Condition code
Physical Medicine / Rehabilitation 288664 288664 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The other two groups (A&B) received conventional treatment in addition to intermittent mechanical cervical traction; the group (A) received the traditional ventroflexion tractionfor 20 minutes, three times per week for four weeks. During the ventroflexion traction the patient was lying supine on a softly padded table with a pillow under the knees for relaxation. The position of the head during traction was adjusted by using a goniometer at 24 degree flexion without rotation or side flexion. the traction force was started at 9.1 kg (20 Ib) or 10% of the patient's body weight (whichever was less) and increased approximately 0.91 to 2.27 kg (2-5 Ib) every visit, depending on centralization or reduction of symptoms. The maximum force used was 15.91 kg (35 Ib). The on/off cycle was set at 50/10.
The group (B), which received the flexor carpi radialis H- reflex based traction method for 20 minutes,
three times per week for four weeks, followed the same procedures of traditional traction with only exception that the optimal head posture was selected according to findings of H reflex. flexor carpi radialis H- reflex amplitude was recorded after the patient maintained the end range of 24 degree head flexion, mid position, 15 degree backward extension and 5 degree backward extension for 20 minutes. The electrophysiological findings represented in peak to peak amplitudes were compared with the findings recorded during comfortable neutral positions. The idea behind this technique is that postural modification can cause amplitude inhibition, indicating more compression of the impinged nerve root, or recovery, indicating decompression of the root. The peak to peak amplitudes was selected as compression –decompression indicator as it is a more sensitive predictor of normal physiologic changes than is latency, which need more long time to be changed .
Intervention code [1] 286478 0
Rehabilitation
Comparator / control treatment
The treatment regimens for control group consisted of physical pain relief methods (infrared, interferential therapy, and massage), muscle strengthening via isometric contraction of flexor and extensor muscles, and thoracic spine manipulation

IR application
The patient was assumed the forward lean sitting position where the area to be treated (the paraspinal muscles of the neck and trapizus muscle) 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
Interferential application
During interferential application, patients were asked to adopt prone position. Interferential treatment was introduced using electrotherapy device ( Phyaction 787 , Netherlands). The interferential therapy was delivered at an amplitude-modulated constant frequency of 100 Hz and a pulse duration of 125 micro s due to its analgesic effect. A 20-min interferential session has been widely accepted within physiotherapy practitioners.
Soft tissue mobilization
Soft tissue mobilization was performed to the muscles of the upper quarter with the involved upper extremity positioned in abduction and external rotation to preload the neural structures of the upper limb.Manual pressure was applied to the soft tissues of the upper quadrant in a deep, stroking manner with the intention to decrease pain and improve the mobility of the soft tissues surrounding the pathway of the neural structures of the upper limb. The therapist concentrated on any tissues on the cervical and scapular region and upper extremity that were graded as tight or tender in the evaluation.


Thoracic Spine Manipulation
Initial treatment included high-velocity, low-amplitude thrust manipulation procedures directed at the upper- and mid-thoracic spines of spinal segments identified as hypomobile during segmental mobility testing34. Although we were unable to locate evidence for the use of thoracic spine manipulation in a patient population with cervical radiculopathy, several studies has demonstrated that an association exists between mobility in the thoracic spine and neck/shoulder pain. Based on these findings, it seems reasonable that a clinician would at least consider utilization of manual therapies to the thoracic spine for patients with cervical radiculopathy.
Strengthening Exercises
Strengthening Exercises Following the thoracic spine manipulation, patients were instructed in and performed exercises focusing on strengthening of the deep neck flexors and scapulothoracic muscles regardless of their strength levels. The patients performed
deep neck flexor strengthening exercises , without the use of a biofeedback unit. The patient was supine, with the cervical spine in neutral, and instructed to flatten the curve of the neck by nodding the head. This position was held for 10 seconds and repeated 10 times.
This conventional treatment was to be repeated three times per week for four weeks. Those in the control group received this conventional treatment only.
Control group
Active

Outcomes
Primary outcome [1] 288810 0
Neck Disability Index: The NDI is a 10-item questionnaire that measures a patient’s self-reported neck pain related disability. Questions include activities of daily living, such as: personal care, lifting, reading, work, driving, sleeping, recreational activities, pain intensity, concentration and headache. The questions are measured on a six-point scale from 0 (no disability) to 5 (full disability). The numeric response for each item is summed for a total score ranging from 0 to 50. A higher NDI score indicates a greater patient’s perceived disability .
Timepoint [1] 288810 0
pre treatment,after 4 weeks of treatment,and at1-year follow up
Secondary outcome [1] 301046 0
The secondary outcome measures included symptoms (neck and arm pain), and neurophysiogical findings (latency and peak to peak amplitude of FCR H- reflex).
Timepoint [1] 301046 0
pre treatment,after 4 weeks of treatment,at 1-year follow up

Eligibility
Key inclusion criteria
Patients were included if they had unilateral C6 or C7 radiculopathy following herniated disc confirmed by imaging (computed tomography [CT] and/or magnetic resonance imaging [MRI]), C6 or C7 dermatomal numbness, and duration of symptoms more than 3 months to avoid acute stage of inflammation. Further, Inclusion criteria for these patients included a test item cluster identified by Wainner et al, which included the presence of 4 positive examination findings (Spurling test, upper limb tension test, cervical distraction test, and less than 60° cervical rotation towards the symptomatic side
Minimum age
35 Years
Maximum age
48 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included the presence of any medical "red flags" (eg, tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged steroid use), History of previous cervical or thoracic spine surgery , Signs or symptoms of upper motor neuron disease, vestibulobasilar insufficiency, osteoporosis, , amyotrophic lateral sclerosis and inability to tolerate cervical flexion or extension position

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 to one of three groups after initial evaluation. They were randomly assigned 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 of different sizes 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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was restricted to permuted blocks of different sizes to ensure equal numbers being allocated to each group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
mixed model analysis with repeated measures

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2010
Actual
1/03/2010
Date of last participant enrolment
Anticipated
1/09/2011
Actual
1/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
216
Accrual to date
Final
Recruitment outside Australia
Country [1] 4854 0
Egypt
State/province [1] 4854 0
cairo

Funding & Sponsors
Funding source category [1] 286701 0
Self funded/Unfunded
Name [1] 286701 0
Ibrahim Moustafa Moustafa
Country [1] 286701 0
Egypt
Primary sponsor type
Individual
Name
Ibrahim Moustafa Moustafa
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] 285472 0
Individual
Name [1] 285472 0
Aliaa Attiah Diab
Address [1] 285472 0
Faculty of Physical Therapy, cairo university, Egypt

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

Postal Code: 12612
Country [1] 285472 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288767 0
faculty counsel for post graduated study and researcher
Ethics committee address [1] 288767 0
Faculty of Physical Therapy - Cairo University 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Ethics committee country [1] 288767 0
Egypt
Date submitted for ethics approval [1] 288767 0
Approval date [1] 288767 0
03/05/2009
Ethics approval number [1] 288767 0

Summary
Brief summary
The purpose of this study was to compare the nerve root function, pain, and disability in patients with discogenic cervical radiculopathy after two different multimodal programs in both the short- and long-term; One of them involves manual therapy, exercise and the traditional ventroflexion traction in which an angle of 24 degree of flexion is considered as an optimal traction angle . The another one involves manual therapy, exercise and new method of traction in which we identify the optimal traction angle based on the maximum recovery of the peak to peak amplitude of flexor carpi radilais H- reflex .in this study ,we hypothesized that the addition of new method of traction to a multimodal program will yield a significant additional benefit to pain, function or disability in patients with cervical radiculopathy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37686 0
Dr Ibrahim Moustafa Moustafa
Address 37686 0
faculty of physical therapy- Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country 37686 0
Egypt
Phone 37686 0
0020127022334
Fax 37686 0
Email 37686 0
ibrahiem.mostafa@pt.cu.edu.eg
Contact person for public queries
Name 37687 0
Dr Ibrahim Moustafa Moustafa
Address 37687 0
faculty of physical therapy- Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country 37687 0
Egypt
Phone 37687 0
0020127022334
Fax 37687 0
Email 37687 0
ibrahiem.mostafa@pt.cu.edu.eg
Contact person for scientific queries
Name 37688 0
Dr Ibrahim Moustafa Moustafa
Address 37688 0
faculty of physical therapy- Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country 37688 0
Egypt
Phone 37688 0
0020127022334
Fax 37688 0
Email 37688 0
ibrahiem.mostafa@pt.cu.edu.eg

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
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