Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000262808
Ethics application status
Approved
Date submitted
29/02/2012
Date registered
5/03/2012
Date last updated
27/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The relationship between movement of individual vertebrae and symptoms in patients with neck pain
Scientific title
For people with neck pain receiving manual therapy treatment, how does their segmental mobility alter in relation to improvements in active range of movement?
Secondary ID [1] 280059 0
nil
Universal Trial Number (UTN)
U1111-1128-7265
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neck pain 285969 0
Condition category
Condition code
Musculoskeletal 286154 286154 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 286164 286164 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive manual therapy treatment for up to eight minutes on one occasion. The treatment will be localised mobilisation to one intervertebral location involving oscillatory movements and will not include high velocity thrusts. Treatment will be performed by a titled musculoskeletal physiotherapist who is registered to practice in Australia.
Intervention code [1] 284382 0
Treatment: Other
Comparator / control treatment
Repeated measures before and after treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286629 0
Measurement of segmental cervical mobility of the cervical spine by comparing segmental posiitons in MRIs taken in neutral before and at their limit of rotation before manual therapy treatment.with MRIs taken at after the participant's range of active movement has improved following in their pre-treatment limit of rotation and their new limit of movement.
Timepoint [1] 286629 0
One treatment session immediately before and after manual therapy intervention.
Secondary outcome [1] 296326 0
changes in stiffness to an externally applied indentor to individual levels of the cervical spine.
Timepoint [1] 296326 0
One treatment session immediately before and after manual therapy intervention.

Eligibility
Key inclusion criteria
Inclusion criteria will be similar to our previous studies for
the symptomatic groups i.e. local neck pain for more than two weeks duration. Active neck rotation will be limited by more than 15 degrees to one side producing less than 4/10 pain at the limit of movement and findings on motion palpation of increased stiffness at a location corresponding to their symptoms.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For all
groups, exclusion criteria will be a current third party claim, a history of
trauma within the previous six months, any contraindications to treatment by
manual therapy, or any contraindications to having a CT scan such as
pregnancy, previous exposure to ionising radiation etc.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All subjects recieve the same intervention.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Repeated measures
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/06/2018
Actual
Date of last participant enrolment
Anticipated
31/10/2018
Actual
Date of last data collection
Anticipated
24/12/2018
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 5035 0
4222
Recruitment postcode(s) [2] 5036 0
4215

Funding & Sponsors
Funding source category [1] 284809 0
Self funded/Unfunded
Name [1] 284809 0
Country [1] 284809 0
Australia
Primary sponsor type
University
Name
Griffith University School of Physiotherapy and Exercise Science
Address
Gold Coast Campus, Queensland 4222
Country
Australia
Secondary sponsor category [1] 283691 0
None
Name [1] 283691 0
Address [1] 283691 0
Country [1] 283691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286798 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 286798 0
Dr Gary Allen
Manager, Research Ethics
Office for Research
G39 room 3.55 Gold Coast Campus
Griffith University, 4222
Queensland
Ethics committee country [1] 286798 0
Australia
Date submitted for ethics approval [1] 286798 0
Approval date [1] 286798 0
28/02/2012
Ethics approval number [1] 286798 0
PES/03/12/HREC

Summary
Brief summary
Aims: Determine how, in people with neck pain, segmental spinal mobility changes following manual therapy.
Background: Little is known about the specific mechanisms underlying neck pain, the subsequent limitation of movement, or the mechanisms of manual therapy interventions. There has been an international focus on improving the understanding of the underlying pathophysiology of spinal pain and on the pathophysiological effects of treatment to improve patient outcomes and reduce the cost and disability associated with spinal pain. One way of accessing this problem is to investigate what aspects of the person's condition changes when they improve following an intervention. Recently, methods involving MRI have become available that will allow such investigations to occur.
Experimental procedure: Participants will be required to:
(i) Undergo a standard physiotherapy assessment which includes taking a patient history and conducting a physical examination to ensure the patient is suitable for manual therapy treatment and that they have a limitation of rotation of at least 10 degrees. (ii) Attend Allamanda Private Hospital or a local radiology facility for assessment and treatment. Here one MRI of the cervical spine examination will be performed.
(iii) Following the MRI, pain and range of rotation will be measured. One therapist will perform a palpation assessment. One segment considered to be contributing to the patient’s symptoms will be marked by taping a 0.8mm diameter sphere that will be visible on the fluoroscopic images. A second therapist will apply a manual therapy treatment for up to 4 mins to the segment selected. The treatment will be repeated until there is an increase of greater than 10 degrees in rotation or up to a maximum of 8 mins, whichever comes first. A second fluoroscopic examination will then be conducted.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33855 0
Dr Neil Tuttle
Address 33855 0
School of Allied Health Sciences, Griffith University Gold Coast Campus. Parklands Dr, Southport QLD 4215, Queensland.
Country 33855 0
Australia
Phone 33855 0
+61` 7 55528930
Fax 33855 0
Email 33855 0
[email protected]
Contact person for public queries
Name 17102 0
Dr Neil Tuttle
Address 17102 0
School of Allied Health Sciences, Griffith University Gold Coast Campus. Parklands Dr, Southport QLD 4215, Queensland.
Country 17102 0
Australia
Phone 17102 0
+61,7,55528930
Fax 17102 0
+61,7,55528674
Email 17102 0
[email protected]
Contact person for scientific queries
Name 8030 0
Dr Neil Tuttle
Address 8030 0
School of Allied Health Sciences, Griffith University Gold Coast Campus. Parklands Dr, Southport QLD 4215, Queensland.
Country 8030 0
Australia
Phone 8030 0
+61,7,55528930
Fax 8030 0
+61,7,55528674
Email 8030 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
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