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Trial registered on ANZCTR


Registration number
ACTRN12610000305022
Ethics application status
Approved
Date submitted
4/04/2010
Date registered
16/04/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of cervical manual traction on the length of the cervical spine in asymptomatic individuals
Scientific title
The effect of cervical manual traction on the length of the cervical spine in asymptomatic individuals:a randomized clinical trial
Secondary ID [1] 1594 0
nil
Universal Trial Number (UTN)
U 1111-1114-5945
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy human volunteers. To prevent radiculopathy and neck pain caused by compression or reduction of intervertebral space 257136 0
Condition category
Condition code
Musculoskeletal 257292 257292 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Before initiating the procedures, all individuals were familiarized with manual cervical traction in order to reduce errors in the positioning and execution of the technique. They were given fixed appointments in a preset schedule for the execution of the radiological examination and the manual cervical traction. For the examination, an initial supine position was adopted on the stretcher of the x-ray device (DC-15KB, 500 mA, Toshiba; Toquio, Japan). The participants were instructed to leave cervical region exposed without the presence of any metallic material which might hamper the execution of the technique. The cervical spine was positioned with the anterior arc of the jaw at 90° in relation to the surface of the table, confirmed by means of a goniometer (Carci). Each participant was instructed to relax his shoulders in order to allow adequate visualization of the neck and to keep the body in a static and relaxed position until the radiological procedure and the cervical manual traction were finished.
For this procedure, the physiotherapist was stationed at the head of stretcher, grasping the participant’s jaw with his right hand and positioning his left hand under the occipital region, with the first and the third fingers in contact with the mastoid process of each side, respectively. After correct positioning of the patient, the radiology technician located the beam cone of incidence, calibrated it to 50 Kilowatts (kV) of penetration with a 0.8 second exposure time at 300 milliamps (totaling 24 mAs). The radiation was directed at the center of the fourth cervical vertebra, on the left lateral of the neck at a constant distance of 80 cm, resulting in simple radiographs of the lateral profile in a standard size of 24 x 30 cm. After the technician confirmed the unimpeded visibility of the vertebrae in the images, the physiotherapist began performing cervical manual traction. To accomplish this, a longitudinal force of distraction between the head and the trunk was applied for 120 seconds, as stipulated previously. After this procedure, in order to record the effects of manual traction, another series of radiographs was executed. After this initial procedural session, the participants were randomized using sealed opaque envelopes into two groups: the control group and the intervention. Each participant of the intervention group received 10 sessions of manual traction (01 session/day) for a period of 10 days. Each session consisted of the following: having the patient in the position of dorsal decubitus, the physiotherapist applied three rounds of manual traction for 120 seconds each, with an interval of 30 seconds between each round. The control group was instructed not to vary from their normal daily activities (DAs) for 10 days from beginnig of manual traction in the other group. The day following the completion of the sessions, a final radiological procedure was performed with both groups
Intervention code [1] 256291 0
Rehabilitation
Comparator / control treatment
The control group were submitted to two radiological procedures, one without traction and another during traction, being supported for 120 seconds. The control group was instructed not to vary from their normal daily activities for 10 days from beginnig of manual traction in the other group.
Control group
Active

Outcomes
Primary outcome [1] 258144 0
The radiographs were sent to a medical radiologist for the measurement of the distances between the second (C2) and seventh (C7) cervical vertebra.
The cervical spine length as assessed using radiography and the Method of Gore for meansurement distance between vertebrae cervical.
Timepoint [1] 258144 0
Day zero - was radiographs with and without manual traction;
Day one - the day began implementation of a technical manual cervical traction;
Day ten day - were repeated radiographs with and without manual traction
Secondary outcome [1] 263897 0
Nil
Timepoint [1] 263897 0
Nil

Eligibility
Key inclusion criteria
Graduates enrolled the Course of Physiotherapy.
Minimum age
18 Years
Maximum age
26 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Excluded individuals with history of pathology of the column, pregnancy suspicion, posture alterations and muscle relaxants medicine use

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
the participants had been randomized by a process of sealed opaque envelopes constituting two groups, she has controlled (n = 31) and intervention (n = 33). And One hundred and ninety and two x rays, before and during the traction and after manual therapy had been numbered (0 the 192) of random form by means of a generated random table in computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software statistica
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
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] 2568 0
Brazil
State/province [1] 2568 0
Londrina/parana

Funding & Sponsors
Funding source category [1] 256755 0
University
Name [1] 256755 0
Londrina State University
Address [1] 256755 0
Department of Physical Therapy, University Hospital of Londrina, Robert Kock Avenue, 60.
CEP: 86038440 - Londrina - Parana.
Country [1] 256755 0
Brazil
Primary sponsor type
University
Name
Londrina State University
Address
Department of Physical Therapy, University Hospital of Londrina, Robert Kock Avenue, 60.
CEP: 86038440 – Londrina - Parana.
Country
Brazil
Secondary sponsor category [1] 256039 0
Individual
Name [1] 256039 0
Roger Burgo de Souza
Address [1] 256039 0
Department of Physical Therapy, University Hospital of Londrina, Robert Kock Avenue, 60.
CEP: 86038440 - Londrina - Parana.
Country [1] 256039 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258770 0
Ethics Comiittee of the Londrina State University
Ethics committee address [1] 258770 0
Department of Physical Therapy, University Hospital of Londrina, Robert Kock Avenue, 60.
CEP: 86038440 - Londrina - Parana.
Ethics committee country [1] 258770 0
Brazil
Date submitted for ethics approval [1] 258770 0
30/11/2005
Approval date [1] 258770 0
19/12/2005
Ethics approval number [1] 258770 0
04348

Summary
Brief summary
To evaluate by means of x ray the effect of the manual traction on the length of the cervical column, in health individuals, and if occurs new adequacy after the application of sessions of manual therapy.
Trial website
Trial related presentations / publications
Only the preliminaries results were published at the Radiologia Brasileira periodic - Radiol Bras. 2008;41(4):245–249.
Public notes

Contacts
Principal investigator
Name 31016 0
Address 31016 0
Country 31016 0
Phone 31016 0
Fax 31016 0
Email 31016 0
Contact person for public queries
Name 14263 0
Roger Burgo de Souza
Address 14263 0
Department of Physical Therapy, University Hospital of Londrina, Av: Robert Kock, 60.
CEP: 86038440 – Londrina - Parana.
Country 14263 0
Brazil
Phone 14263 0
55 - 43 - 3371-2288
Fax 14263 0
Email 14263 0
spine@uel.br
Contact person for scientific queries
Name 5191 0
Roger Burgo de Souza
Address 5191 0
Department of Physical Therapy, University Hospital of Londrina, Robert Kock Avenue, 60.
CEP: 86038440 – Londrina - Parana.
Country 5191 0
Brazil
Phone 5191 0
55 - 43 - 3371-2288
Fax 5191 0
Email 5191 0
spine@uel.br

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