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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]

nil

Universal Trial Number (UTN)

U1111-1128-7265

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

neck pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

Treatment: Other

Comparator / control treatment

Repeated measures before and after treatment.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

One treatment session immediately before and after manual therapy intervention.

Secondary outcome [1]

changes in stiffness to an externally applied indentor to individual levels of the cervical spine.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4222

Recruitment postcode(s) [2]

4215

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Human Research Ethics Committee

Ethics committee address [1]

Dr Gary Allen
Manager, Research Ethics
Office for Research
G39 room 3.55 Gold Coast Campus
Griffith University, 4222
Queensland

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

28/02/2012

Ethics approval number [1]

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

Dr Neil Tuttle

Address

School of Allied Health Sciences, Griffith University Gold Coast Campus. Parklands Dr, Southport QLD 4215, Queensland.

Country

Australia

Phone

+61` 7 55528930

Fax

[email protected]

Contact person for public queries

Name

Neil Tuttle

Address

School of Allied Health Sciences, Griffith University Gold Coast Campus. Parklands Dr, Southport QLD 4215, Queensland.

Country

Australia

Phone

+61,7,55528930

Fax

+61,7,55528674

[email protected]

Contact person for scientific queries

Name

Neil Tuttle

Address

School of Allied Health Sciences, Griffith University Gold Coast Campus. Parklands Dr, Southport QLD 4215, Queensland.

Country

Australia

Phone

+61,7,55528930

Fax

+61,7,55528674

[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

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
New Record*	Study results article	Yes	https://doi.org/10.1016/j.msksp.2021.102457	Tuttle, N., Evans, K., & dos Santos Rocha, C. S. (... [More Details]	Abstract.docx

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