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Trial registered on ANZCTR


Registration number
ACTRN12616000446460
Ethics application status
Approved
Date submitted
1/04/2016
Date registered
6/04/2016
Date last updated
26/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Approaches to Mobilisation for Neck Pain Pilot
Scientific title
Comparison of pragmatic and prescriptive approaches to cervical mobilisation for recent onset neck pain: a Pilot Randomised Controlled Trial
Secondary ID [1] 288900 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AtoM Neck Pain Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute / subacute neck pain 298235 0
Condition category
Condition code
Musculoskeletal 298372 298372 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 298422 298422 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pragmatic neck mobilisation: Cervical Spine Mobilisation in which the selected technique, target spinal segment, and dose will be determined by the treating practitioner on the basis of their assessment findings. The clinical assessment of the treating physiotherapist is not standardised. The techniques which the treating practitioner may choose will be restricted to therapist-applied or -assisted movements that are applied directly or indirectly to the spine with the purpose of moving the joints of the cervical spine. The treating practitioner may choose the side of the spine targeted or direction of movement. The treating practitioner may choose individual dosage parameters including the grade of movement (according to the grading of passive movements described by Maitland 1986), the duration (seconds) and the number of times the mobilisation is applied up to a maximum of three separate sets. All participants will receive a single treatment session of up to 10 minutes duration. The treating practitioner will record details of the techniques and dosage chosen using standardised forms
The treating practitioners will be physiotherapists with post-graduate qualification in manual therapy, be recognised as titled musculoskeletal physiotherapists or specialist musculoskeletal physiotherapists by the Australian Physiotherapy Association and have at least 10 years of clinical experience. The treating practitioners will receive specific training in implementation of the trial protocol, work-health and safety induction and training in emergency procedures. Treatments will take place in the university clinical laboratory.
Intervention code [1] 294356 0
Treatment: Other
Intervention code [2] 294412 0
Rehabilitation
Comparator / control treatment
.Prescriptive neck mobilisation: Cervical Spine Mobilisation selected technique, target spinal segment, and dose are prescribed. This treatment will include; (i) C1/2 unilateral postero-anterior pressure described by Maitland (1986) applied to the right and left sides of the neck, Grade IV, for one set of 30 sec, and (ii) T1/2 central postero-anterior pressure described by Maitland (1986) applied to the spinous process of T1, Grade IV, for one set of 30 sec. All participants will receive a single treatment session of up to 10 minutes duration.
The treating practitioners will be physiotherapists with post-graduate qualification in manual therapy, be recognised as titled musculoskeletal physiotherapists or specialist musculoskeletal physiotherapists by the Australian Physiotherapy Association and have at least 10 years of clinical experience. The treating practitioners will receive specific training in implementation of the trial protocol, work-health and safety induction and training in emergency procedures. Treatments will take place in the university clinical laboratory.
Control group
Active

Outcomes
Primary outcome [1] 297845 0
Neck Disability Index Vernon and Mior (1996)
Timepoint [1] 297845 0
Baseline, immediate post-intervention, 48 hours post-intervention
Secondary outcome [1] 322412 0
Average Neck Pain over past 24 hours (Numeric Pain Rating Scale 0-10)
Timepoint [1] 322412 0
Baseline assessment, immediate post-intervention, 48 hours post-intervention
Secondary outcome [2] 322413 0
Cervical Spine Range of Motion measured with a CROM device (Rheault 1992)
Timepoint [2] 322413 0
Baseline assessment, immediate post-intervention
Secondary outcome [3] 322414 0
Global Perceived Effect Scale
Timepoint [3] 322414 0
48 hours post intervention

Eligibility
Key inclusion criteria
Adults of both sexes aged 18-60 years
- Primary complaint of neck pain in region described by Merskey (1994)
- Neck pain that is aggravated by particular movements or positions, and fully or partially relieved by rest.
- Of less than 6 weeks duration,
- Pain score at least 2/10 NRS
- Disability score (NDI) greater than 10%.
- Score of less than 105 on the Orebro Musculoskeletal Pain Questionnaire
- Able to complete written questionnaires in English.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of whiplash or significant neck trauma
- History of cervical spine fracture or spinal surgery
- History of serious illness e.g TB, HIV, cancer or inflammatory arthritis
- Presence of ‘red flag’ symptoms: fever, chills night sweats, recent unexplained weight loss, recent infection
- Neck pain that is unrelieved by rest
- Neck mobility that is restricted in all directions.
- Signs of widespread sensitisation
- Signs of radiculopathy or myelopathy
- Deemed unsuitable for manipulation by the treating practitioner

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)
Sequentially numbered, sealed, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
20 participants will be recruited for the pilot-study.
The sample size for extension of the pilot to a suitably powered RCT is 100. The sample size has been calculated for a probability of 90% that the study will detect a treatment difference at a two-sided 0.05 significance level, of 5.0 points on the Neck Disability Index (SD=7.0) allowing for 15% dropout. Baseline demographic and clinical data will be reported using descriptive statistics. Between group differences will be assessed for these baseline characteristics using independent t-tests. The effectiveness of the two interventions will be compared using linear mixed models that will test the between-group difference in post treatment disability scores.

Recruitment
Recruitment status
Not yet recruiting
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 in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 13003 0
2141 - Lidcombe

Funding & Sponsors
Funding source category [1] 293253 0
University
Name [1] 293253 0
The University of Sydney
Address [1] 293253 0
Faculty of Health Sciences
Cumberland Campus C42
The University of Sydney
PO Box 170
Lidcombe NSW 1825
AUSTRALIA
Country [1] 293253 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Health Sciences
Cumberland Campus C42
The University of Sydney
PO Box 170
Lidcombe NSW 1825
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 292054 0
None
Name [1] 292054 0
Address [1] 292054 0
Country [1] 292054 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294732 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 294732 0
Level 6, Jane Foss Russell,
the University of Sydney. NSW 2006 Australia
Ethics committee country [1] 294732 0
Australia
Date submitted for ethics approval [1] 294732 0
29/02/2016
Approval date [1] 294732 0
11/04/2016
Ethics approval number [1] 294732 0
2016/222

Summary
Brief summary
Neck pain is highly prevalent and a leading cause of disability worldwide. Manual therapies are commonly used to treat neck pain, and there is some evidence of the effectiveness of mobilisation and manipulation for neck pain. When compared with each other, mobilisation and manipulation have been shown to have similar effects. In light of the potential serious adverse events associated with manipulation, the Cochrane Back and Neck Group have highlighted further investigation of mobilisation as a research priority. Additionally, with little information available about which are the most effective techniques and approaches to mobilisation, the Cochrane Group has recommended future research also focus on addressing this question. There are currently two distinctly different approaches to cervical spine mobilisation for people with neck pain. A pragmatic approach is based on the assumption that individualised treatments, with key dosage parameters determined by careful assessment of pain and movement are important determinants of outcome. A prescriptive approach is based on the assumption that standardised techniques and dose are effective, and that patient selection is the main determinant of outcome. This pilot study will investigate the feasibility of a trial to determine whether a pragmatic or a prescriptive approach to cervical spine mobilisation more effective in relieving pain and restoring function in people with recent onset neck pain
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64850 0
Dr Andrew Leaver
Address 64850 0
Faculty of Health Sciences
University of Sydney Cumberland Campus (C42)
75 East Street, Lidcombe, NSW 2141,


Country 64850 0
Australia
Phone 64850 0
+61 2 9351 9545
Fax 64850 0
Email 64850 0
andrew.leaver@sydney.edu.au
Contact person for public queries
Name 64851 0
Dr Justin Sullivan
Address 64851 0
Faculty of Health Sciences
University of Sydney Cumberland Campus(C42)
75 East Street, Lidcombe, NSW 2141,
Country 64851 0
Australia
Phone 64851 0
+61 2 9351 9156
Fax 64851 0
Email 64851 0
justin.sullivan@sydney.edu.au
Contact person for scientific queries
Name 64852 0
Dr Andrew Leaver
Address 64852 0
Faculty of Health Sciences
University of Sydney Cumberland Campus(C42)
75 East Street, Lidcombe, NSW 2141,
Country 64852 0
Australia
Phone 64852 0
+61 2 9351 9545
Fax 64852 0
Email 64852 0
andrew.leaver@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
No Results