Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000303640
Ethics application status
Approved
Date submitted
12/03/2014
Date registered
21/03/2014
Date last updated
19/02/2021
Date data sharing statement initially provided
19/02/2021
Date results information initially provided
19/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Using neuroimaging and motion analysis to better diagnose and treat chronic neck pain
Scientific title
Is physiotherapy with task-specific training more effective than physiotherapy alone in reducing pain, improving kinematics and reversing maladaptive cortical changes in patients with insidious-onset non-specific neck pain?
Secondary ID [1] 284246 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
insidious-onset non-specific neck pain 291364 0
Condition category
Condition code
Musculoskeletal 291729 291729 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 291801 291801 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will receive 6 visits (approximately 1 hour each) of evidenced-based physiotherapy consisting of manual therapy and exercise delivered approximately weekly over 6 weeks. Manual therapy will consist of passive physiological and passive accessory mobilisation/manipulation at the discretion of the treating therapist. Exercise will consist of active range of motion, specific muscle training exercises for deep neck flexors and extensors, postural correction and graded muscle strengthening exercises for neck and upper limbs to the appropriate level for the patient. The intervention group will also receive task-specific training, consisting of repetitive practice of specific functional tasks with kinematic correction from the treating therapist.
Intervention code [1] 288955 0
Rehabilitation
Intervention code [2] 289008 0
Diagnosis / Prognosis
Intervention code [3] 289009 0
Treatment: Other
Comparator / control treatment
All patients with neck pain will receive 1 x 1 hour session per week for 6 weeks of physiotherapy consisting of manual therapy and exercise. The intervention group will also receive task-specific training as part of their treatment.
Healthy controls do not receive any intervention.
Control group
Active

Outcomes
Primary outcome [1] 291664 0
Pain (visual analogue scale, VAS, for pain now, and separate VAS for pain over the last 24 hours) for patients with neck pain.
Timepoint [1] 291664 0
Baseline, post-treatment (7 weeks from baseline) and 6 months (26 weeks) from baseline for patients with neck pain.
Primary outcome [2] 291665 0
Kinematic changes during functional tasks (e.g., overhead reach, putting on seatbelt) as measured using 3-D motion analysis for patients with neck pain and for healthy controls.
Timepoint [2] 291665 0
Baseline, post-treatment (7 weeks from baseline) and 6 months (26 weeks) from baseline for patients with neck pain. Healthy controls will be measured at baseline and at 6 months.
Primary outcome [3] 291666 0
Cortical changes as measured by magnetic resonance imaging (structural, functional, chemical) for patients with neck pain and for healthy controls.
Timepoint [3] 291666 0
Baseline, post-treatment (7 weeks from baseline) and 6 months (26 weeks) from baseline for patients with neck pain. Healthy controls will be measured at baseline and at 6 months.
Secondary outcome [1] 307253 0
Spinal stiffness (slope of the force-displacement curve) meaured objectively using a custom device applying 5 repetitions of standardised oscillatory force to the painful spinel level, for patients with neck pain and for healthy controls.
Timepoint [1] 307253 0
Baseline, post-treatment (7 weeks from baseline) and 6 months (26 weeks) from baseline for patients with neck pain. Healthy controls will be measured at baseline and at 6 months.
Secondary outcome [2] 307254 0
muscle performance on the clinical deep neck flexor test measured using EMG, for patients with neck pain and for healthy controls.
Timepoint [2] 307254 0
Baseline, post-treatment (7 weeks from baseline) and 6 months (26 weeks) from baseline for patients with neck pain. Healthy controls will be measured at baseline and at 6 months.
Secondary outcome [3] 307255 0
Pressure pain threshold measured with the J-tech alogometer adjacent to the painful spinal level, at the median nerve trunk at the elbow and at the mid-upper trapezius muscle, for patients with neck pain and for healthy controls. (Pressure is applied increasing increments at a standard rate and participant indicates the moment when the sensation changes from one of pressure to one of pain at which point the test stops and a value is recorded.)
Timepoint [3] 307255 0
Baseline, post-treatment (7 weeks from baseline) and 6 months (26 weeks) from baseline for patients with neck pain. Healthy controls will be measured at baseline and at 6 months.
Secondary outcome [4] 307256 0
Cervical range of motion as measured with the CROM device, for patients with neck pain and for healthy controls.
Timepoint [4] 307256 0
Baseline, post-treatment (7 weeks from baseline) and 6 months (26 weeks) from baseline for patients with neck pain. Healthy controls will be measured at baseline and at 6 months.
Secondary outcome [5] 307257 0
Neck Disability Index, for patients with neck pain.
Timepoint [5] 307257 0
Baseline, post-treatment (7 weeks from baseline) and 6 months (26 weeks) from baseline for patients with neck pain.
Secondary outcome [6] 307258 0
Quality of life/ impact of pain measured using the SF-12, PIQ, and GHQ-28, for patients with neck pain and for healthy controls.
Timepoint [6] 307258 0
Baseline, post-treatment (7 weeks from baseline) and 6 months (26 weeks) from baseline for patients with neck pain. Healthy controls will be measured at baseline and at 6 months.
Secondary outcome [7] 344825 0
Clinical balance measures (number of seconds up to 30 and sway of centre of mass calculated from 3-D motion analysis) during static standing with eyes open and closed (narrow and tandem stance, on firm and foam surfaces)
Timepoint [7] 344825 0
Baseline, post-treatment (7 weeks from baseline) and 6 months (26 weeks) from baseline for patients with neck pain. Healthy controls will be measured at baseline and at 6 months.

Eligibility
Key inclusion criteria
Neck pain participants:
(1) chronic non-specific neck pain (> 90 days), rated at least 4/10 on a 0-10 numerical rating scale, and reported to at least 'moderately' interfere with normal activities over the previous 4 weeks
(2) aged between 18 and 55 years
(3) be able to lie in a cylindrical magnet on their back
(4) free from any metallic implants
Healthy controls:
(1) aged between 18 and 55 years
(2) be able to lie in a cylindrical magnet on their back
(3) free from any metallic implants
(4) matched to a neck pain participant by age and gender
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neck pain participants:
(1) claustrophobic
(2) upper cervical pain, headache, or dizziness as their primary complaint
(3) history of migraine headaches
(4) history of trauma related to the neck (e.g. whiplash)
(5) surgery to the neck
(6) diabetes
(7) peripheral vascular disease
(8) referred arm pain past the tip of the shoulder
(9) neuropathic type pain (score of 10 or more on s-LANSS)
(10) currently receiving hands on treatment for their neck pain (e.g., physiotherapy, chiropractic, acupuncture, massage or similar) in the last 12 weeks
(11) on workers' compensation
(12) pregnant or breastfeeding

Healthy controls:
(1) claustrophobic
(2) pregnant or breastfeeding
(3) any neck or back pain for which they sought treatment in the previous 2 years
(4) any previous history of injury or trauma to the neck (e.g., whiplash)
(5) any current musculoskeletal pain in any body area

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)
Lead CI (Snodgrass) will screen participants, enrol them into the study and remain blinded to group. Statistician (McElduff) will generate the randomisation sequence as described below, which will be given to the treating physiotherapist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Neck pain participants will be assigned through concealed allocation and independent randomisation using a random numbers generator to one of two groups: physiotherapy with task-specific training or physiotherapy alone. The Clinical Research Design, IT and Statistical Support (CReDITSS) unit within the Hunter Medical Research Institute will oversee randomisation. Participants will be randomly allocated to the two groups using a randomised block design stratified by age and gender. Group allocation will be created dynamically with block sizes varying randomly from 4 to 6 and the randomisation schedule will be delivered via secure web-based interface to ensure allocation is concealed.
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
This is a pilot study. Estimates of sample size were based on previous studies comparing cortical changes in patients with low back pain to healthy controls (e.g., Siddall et al. 2006, Anesth Analg 102: 1164-1168), and in studies evaluating cortical changes following intervention in low back pain (e.g., Seminowicz et al. 2011, J Neuroscience 31:7540-7550). Twenty patients with chronic neck pain will be recruited and randomised to the intervention and control groups (10 in each group). Twenty age and gender healthy controls will be recruited for comparisons at baseline.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/04/2014
Actual
25/05/2015
Date of last participant enrolment
Anticipated
19/12/2014
Actual
1/02/2016
Date of last data collection
Anticipated
Actual
1/06/2016
Sample size
Target
30
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7863 0
2308 - Newcastle University

Funding & Sponsors
Funding source category [1] 288876 0
Charities/Societies/Foundations
Name [1] 288876 0
Ramaciotti Foundation
Country [1] 288876 0
Australia
Primary sponsor type
Individual
Name
Dr Suzanne Snodgrass
Address
School of Health Sciences
University of Newcastle
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 287570 0
University
Name [1] 287570 0
The University of Newcastle
Address [1] 287570 0
The University of Newcastle
University Drive
Callaghan NSW 2308
Country [1] 287570 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290705 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 290705 0
Research Office, The Chancellery, The University of Newcastle, University Drive, Callaghan NSW 2308
Ethics committee country [1] 290705 0
Australia
Date submitted for ethics approval [1] 290705 0
Approval date [1] 290705 0
09/01/2014
Ethics approval number [1] 290705 0
H-2013-0416

Summary
Brief summary
The purpose of the research is to investigate brain and movement-related biomarkers associated with chronic neck pain, and determine if these can be used to increase the effectiveness of manual therapy and exercise treatment for neck pain. Patients with insidious-onset non-specific neck pain will be compared with healthy age and gender matched control participants at baseline to determine brain and movement-related biomarkers associated with neck pain. Neck pain participants will be randomised to receive 6 sessions of physiotherapy (manual therapy + exercise) with task-specific training or physiotherapy alone. Assessments will occur a baseline, post-treatment (7 weeks form baseline) and 6 months (26 weeks form baseline). Outcome measures are pain (VAS), kinematic biomarkers measured with 3-D motion analysis, cortical biomarkers measured with magnetic resonance imaging (structural imaging, diffusion tensor imaging, resting-state functional MRI, and MR spectroscopy), and clinical measures including spinal stiffness, muscle performance on the deep neck flexor test, pressure pain threshold, cervical range of motion, Neck Disability Index, SF-12, Pain Impact questionnaire, and General Health Questionnaire-28. This pilot study will (1) determine potential cortical and kinematic biomarkers that can be used to develop targeted interventions for neck pain, and (2) determine if physiotherapy (with or without task-specific training) has effects on cortical and kinematic biomarkers and reduces pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46874 0
Dr Suzanne Snodgrass
Address 46874 0
School of Health Sciences
The University of Newcastle
University Drive
Callaghan, NSW 2308
Country 46874 0
Australia
Phone 46874 0
+61 2 49212089
Fax 46874 0
+61 2 49217053
Email 46874 0
[email protected]
Contact person for public queries
Name 46875 0
Dr Suzanne Snodgrass
Address 46875 0
School of Health Sciences
The University of Newcastle
University Drive
Callaghan, NSW 2308
Country 46875 0
Australia
Phone 46875 0
+61 2 49212089
Fax 46875 0
+61 2 49217053
Email 46875 0
[email protected]
Contact person for scientific queries
Name 46876 0
Dr Suzanne Snodgrass
Address 46876 0
School of Health Sciences
The University of Newcastle
University Drive
Callaghan, NSW 2308
Country 46876 0
Australia
Phone 46876 0
+61 2 49212089
Fax 46876 0
+61 2 49217053
Email 46876 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.