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Trial registered on ANZCTR


Registration number
ACTRN12615000256572
Ethics application status
Approved
Date submitted
6/03/2015
Date registered
19/03/2015
Date last updated
26/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study to discover neural and kinematic biomarkers in chronic non-specific neck pain that provide biological evidence for patient outcomes following chiropractic care
Scientific title
Is chiropractic manual therapy using the Gonstead technique more effective than a waiting list in reducing pain, improving kinematics and reversing maladaptive cortical changes in patients with insidious-onset non-specific neck pain?
Secondary ID [1] 285732 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 293618 0
Condition category
Condition code
Musculoskeletal 293906 293906 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 293907 293907 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients allocated to the treatment group will receive 6 45-minute visits of chiropractic manual therapy consisting of a clinical assessment and the application of the Gonstead technique, delivered weekly over 6 weeks. The Gonstead technique is a commonly applied chiropractic manipulation involving a rapidly applied firm pressure to the neck that may or may not result in an audible click.
Intervention code [1] 290688 0
Rehabilitation
Comparator / control treatment
A wait list control group of individuals with neck pain will participate in the three measurement sessions only. These individuals will be offered the intervention following their last measurement session at 6 months. It would not be unusual for patients with chronic neck pain to have long periods of time between treatment and there are often wait lists for chronic spinal pain treatment in the public health system. Therefore being on a wait-list is consistent with normal practice and not detrimental to the participants.
A second group of age and gender-matched healthy control participants will be recruited and will participate in measurement sessions at baseline and at 6 months.
Control group
Active

Outcomes
Primary outcome [1] 293679 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] 293679 0
Baseline, post-treatment (6 weeks from baseline) and 6 months (26 weeks) from baseline for patients with neck pain.
Primary outcome [2] 293680 0
Cortical changes as measured by magnetic resonance imaging for patients with neck pain and for healthy controls.
Timepoint [2] 293680 0
Baseline, post-treatment (6 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] 293681 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 [3] 293681 0
Baseline, post-treatment (6 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] 311583 0
Spinal stiffness (slope of the force-displacement curve) measured
objectively using a custom device applying 5 repetitions of standardised oscillatory force to the painful spinal level, for patients with neck pain and for healthy controls.
Timepoint [1] 311583 0
Baseline, post-treatment (6 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] 311584 0
Muscle performance on the clinical deep neck flexor test measured using EMG, for patients with neck pain and for healthy controls.
Timepoint [2] 311584 0
Baseline, post-treatment (6 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] 311585 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] 311585 0
Baseline, post-treatment (6 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] 311586 0
Cervical range of motion as measured with the CROM device, for patients with neck pain and for healthy controls.
Timepoint [4] 311586 0
Baseline, post-treatment (6 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] 311587 0
Neck Disability Index, for patients with neck pain.
Timepoint [5] 311587 0
Baseline, post-treatment (6 weeks from baseline) and 6 months (26 weeks) from baseline for patients with neck pain.
Secondary outcome [6] 311588 0
Quality of life/ impact of pain measured using the SF-12, Pain Impact Questionnaire, and GHQ-28, for patients with neck pain and for healthy controls.
Timepoint [6] 311588 0
Baseline, post-treatment (6 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
Gender
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
(13) conditions that prohibit manual treatment to the neck including: known history of cancer, inflammatory diseases such as rheumatoid arthritis, infectious diseases affecting the neck, osteoporosis, nerve root pain, instability in the neck or symptoms such as dizziness or double vision.

Healthy controls:
(1) claustrophobic
(2) any neck or back pain for which they sought treatment in the previous 2 years
(3) any previous history of injury or trauma to the neck (e.g., whiplash)
(4) any current musculoskeletal pain in any body area
(also excluded if they have any of the factors listed in exclusions 3 through 12 for the neck pain group)

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) and research assistant Scott Farrell 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 chiropractor.
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: chiropractic manual treatment techniques or a waiting list. 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 and the randomisation schedule will be delivered via sealed envelopes prepared by CREDITSS and provided to the treating chiropractor.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
Data from 10 patients with chronic neck pain will be compared to 10 control participants. With this number of participants we can detect a 1 SD difference between groups with 80% power. However, this is a pilot study and the results of this study will provide data to accurately calculate sample size for a future larger study. Data from the pilot randomised controlled trial (5 participants in each group) will be reported descriptively. If the findings show potential levels of significance, then appropriate statistical tests will be used to further describe the results. The target for recruitment has been set at 25 to allow for possible attrition.

Recruitment
Recruitment status
Completed
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] 8988 0
2308 - Newcastle University

Funding & Sponsors
Funding source category [1] 290307 0
Charities/Societies/Foundations
Name [1] 290307 0
Australian Spinal Research Foundation
Address [1] 290307 0
15 Dennis Rd, Springwood QLD 4127
Country [1] 290307 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] 289018 0
University
Name [1] 289018 0
The University of Newcastle
Address [1] 289018 0
The University of Newcastle
University Drive
Callaghan NSW 2308
Country [1] 289018 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300007 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 300007 0
Research & Innovation Service, The University of Newcastle, University Drive, Callaghan NSW 2308, Australia
Ethics committee country [1] 300007 0
Australia
Date submitted for ethics approval [1] 300007 0
Approval date [1] 300007 0
20/08/2014
Ethics approval number [1] 300007 0
H-2014-0233

Summary
Brief summary
The purpose of this research is to improve the diagnosis and treatment of chronic neck pain. Biomarkers from 10 individuals with chronic non-specific neck pain will be compared to 10 healthy age and gender matched control participants at baseline and six months from baseline. Neck pain participants will be randomised to either receive a chiropractic manual treatment technique (6 sessions) or be on a waiting list. For the neck pain group, biomarkers will be measured at baseline, immediately after treatment (6 weeks from baseline) and at 6-months from baseline.

Outcome measures are pain (VAS), cortical biomarkers measured with magnetic resonance imaging (structural imaging, diffusion tensor imaging, resting-state functional MRI, and MR spectroscopy), kinematic biomarkers measured with 3-D motion analysis, 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 chiropractic manual therapy has effects on cortical and kinematic biomarkers and reduces pain.
Trial website
Trial related presentations / publications
Blyton SJ, Edwards S, Moghaddas D, de Zoete RMJ, Palazzi, K, Oldmeadow C, Bolton P, Rivett DA, Snodgrass SJ. Associations between neck kinematics and pain individuals with chronic idiopathic neck pain. Australian Physiotherapy Association Biennial Conference, October 2017, Sydney.
Public notes

Contacts
Principal investigator
Name 52794 0
A/Prof Suzanne Snodgrass
Address 52794 0
School of Health Sciences The University of Newcastle University Drive Callaghan, NSW 2308
Country 52794 0
Australia
Phone 52794 0
+61 2 49212089
Fax 52794 0
+61 2 49217053
Email 52794 0
Suzanne.Snodgrass@newcastle.edu.au
Contact person for public queries
Name 52795 0
A/Prof Suzanne Snodgrass
Address 52795 0
School of Health Sciences The University of Newcastle University Drive Callaghan, NSW 2308
Country 52795 0
Australia
Phone 52795 0
+61 2 49212089
Fax 52795 0
+61 2 49217053
Email 52795 0
Suzanne.Snodgrass@newcastle.edu.au
Contact person for scientific queries
Name 52796 0
A/Prof Suzanne Snodgrass
Address 52796 0
School of Health Sciences The University of Newcastle University Drive Callaghan, NSW 2308
Country 52796 0
Australia
Phone 52796 0
+61 2 49212089
Fax 52796 0
+61 2 49217053
Email 52796 0
Suzanne.Snodgrass@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary