ANZCTR - Registration

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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]

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

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

Treatment: Other

Intervention code [2]

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]

Neck Disability Index Vernon and Mior (1996)

Timepoint [1]

Baseline, immediate post-intervention, 48 hours post-intervention

Secondary outcome [1]

Average Neck Pain over past 24 hours (Numeric Pain Rating Scale 0-10)

Timepoint [1]

Baseline assessment, immediate post-intervention, 48 hours post-intervention

Secondary outcome [2]

Cervical Spine Range of Motion measured with a CROM device (Rheault 1992)

Timepoint [2]

Baseline assessment, immediate post-intervention

Secondary outcome [3]

Global Perceived Effect Scale

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

27/04/2016

Actual

Date of last participant enrolment

Anticipated

30/12/2016

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]

2141 - Lidcombe

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Sydney

Address [1]

Faculty of Health Sciences
Cumberland Campus C42
The University of Sydney
PO Box 170
Lidcombe NSW 1825
AUSTRALIA

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Level 6, Jane Foss Russell, 
the University of Sydney. NSW 2006 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/02/2016

Approval date [1]

11/04/2016

Ethics approval number [1]

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

Dr Andrew Leaver

Address

Faculty of Health Sciences
University of Sydney Cumberland Campus (C42)
75 East Street, Lidcombe, NSW 2141,

Country

Australia

Phone

+61 2 9351 9545

Fax

andrew.leaver@sydney.edu.au

Contact person for public queries

Name

Justin Sullivan

Address

Faculty of Health Sciences
University of Sydney Cumberland Campus(C42)
75 East Street, Lidcombe, NSW 2141,

Country

Australia

Phone

+61 2 9351 9156

Fax

justin.sullivan@sydney.edu.au

Contact person for scientific queries

Name

Andrew Leaver

Address

Faculty of Health Sciences
University of Sydney Cumberland Campus(C42)
75 East Street, Lidcombe, NSW 2141,

Country

Australia

Phone

+61 2 9351 9545

Fax

andrew.leaver@sydney.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Approaches to cervical spine mobilization for neck pain: a pilot randomized controlled trial.	2020	https://dx.doi.org/10.1186/s12998-020-00348-z

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically