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Trial registered on ANZCTR


Registration number
ACTRN12611000374965
Ethics application status
Approved
Date submitted
24/03/2011
Date registered
11/04/2011
Date last updated
26/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dose Optimisation for Spinal treatment Effectiveness (The DOSE Study): A randomised controlled pilot trial investigating the effects of high and low mobilisation forces in patients with neck pain
Scientific title
In patients with chornic non-specific neck pain, is a high force mobilisation better than a low force mobilisation or laser for immediate improvement in pressure pain threshold scores?
Secondary ID [1] 259857 0
Nil
Universal Trial Number (UTN)
U1111-1120-2738
Trial acronym
The DOSE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic non-specific neck pain 265438 0
Condition category
Condition code
Musculoskeletal 265594 265594 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. High force mobilisation will consist of a single application of 3 sets of 30 seconds of oscillating pressures manually applied by thhe physiotherapist' thumbs with a mean peak force of 90N to the symptomatic spinal level. 2. Low force mobilisation will consist of a single application of 3 sets of 30 seconds of oscillating pressures manually applied by thhe physiotherapist' thumbs with a mean peak force of 30N to the symptomatic spinal level. 3. Laser will consist of a single application of 3 sets of 30 seconds application applied using the Echolac with probe to skin contact over the symptomatic level. Laser was detuned (i.e., not active) and represented the placebo group, or an inactive treatment control.
Intervention code [1] 264275 0
Treatment: Other
Comparator / control treatment
treatment: 1. High force mobilisation will consist of a single application of 3 sets of 30 seconds of oscillating pressures manually applied by thhe physiotherapist' thumbs with a mean peak force of 90N to the symptomatic spinal level. 2. Low force mobilisation will consist of a single application of 3 sets of 30 seconds of oscillating pressures manually applied by thhe physiotherapist' thumbs with a mean peak force of 30N to the symptomatic spinal level. 3. Laser will consist of a single application of 3 sets of 30 seconds application applied using the Echolac with probe to skin contact over the symptomatic level. Laser was deactivated and therefore was the placebo control group.
Control group
Placebo

Outcomes
Primary outcome [1] 262388 0
Pressure pain threshold (PPT) will be measured with the J-tech algometer (Tracker Freedom Algometry, J-tech Medical (http://jtechmedical.net/products/pain_eval/freedom/freedom_algometry.cfm) over the following landmarks in randomised order: (1) Adjacent to the spinous process at the treated spinal level (right side) (2) Right upper trapezius muscle (3) Right median nerve trunk at the elbow. Measurements will be taken in triplicate and averaged for each landmark.
Timepoint [1] 262388 0
Immediately before treatment application, immediately after treatment application and one follow-up 3-5 days later
Secondary outcome [1] 273681 0
Cervical range of motion will be measured with a Cervical Range of Motion instrument (CROM, Performance Attainment Associates, Minnesota, USA, http://www.spineproducts.com/) in the following ranges: (1)Total sagittal plane ROM, (2) Total horizontal plane ROM and (3) Position (degrees) at first onset or increase in pain with movement towards the most painful movement direction. Measurements will be taken in triplicate and averaged.
Timepoint [1] 273681 0
Immediately before treatment application, immediately after treatment application and one follow-up 3-5 days later
Secondary outcome [2] 273682 0
Cervical spine stiffness will be measured with a customised device that applied 5 standardised oscillating pressures to the spinous process using a probe while recording the resistance to movement and the distance the probe travels. The relationship between resistance and displacement (distance) represents the spinal stiffness (N/mm). The symptomatic spinal level as well as C7 (for normalisation)will be measured.
Timepoint [2] 273682 0
Immediately before treatment application, immediately after treatment application and one follow-up 3-5 days later
Secondary outcome [3] 273683 0
Patient reported pain (visual analogue scale)
Timepoint [3] 273683 0
Immediately before treatment application, immediately after treatment application and one follow-up 3-5 days later

Eligibility
Key inclusion criteria
chronic non-specific neck pain (> 90 days)
aged between 18 and 55 years
minimum average resting pain level over the previous 3 days of 3/10
report of neck pain that at least ‘moderately’ interferes with their normal work (work and housework)
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
upper cervical pain, headache or dizziness as their primary complaint
migraine
history of trauma related to the neck,
surgery to the neck
diabetes
peripheral vascular disease
referred arm pain past the tip of the shoulder
currently receiving other physical treatments for their neck pain (e.g., physiotherapy, chiropractic, acupuncture or similar)

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)
Subjects will be screened for contraindicated conditions prior to enrolling in the study. Patients will be assigned to treatment groups through random allocation using opaque envelopes, opened on the day of data collection affter initial measurements are taken. The researcher doing the recruiting will have no knowledge of the treattment group of potential participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomised number sequence is generated through a computer program available online.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264732 0
Charities/Societies/Foundations
Name [1] 264732 0
Physiotherapy Research Foundation
Country [1] 264732 0
Australia
Primary sponsor type
Individual
Name
Suzanne Snodgrass
Address
School of Health Sciences
Hunter Building
Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 263858 0
University
Name [1] 263858 0
The University of Newcastle
Address [1] 263858 0
School of Health Sciences
Hunter Building
Callaghan, NSW 2308
Country [1] 263858 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266721 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 266721 0
Research Services
Research Integrity Unit
HA148, Hunter Building
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 266721 0
Australia
Date submitted for ethics approval [1] 266721 0
Approval date [1] 266721 0
21/03/2011
Ethics approval number [1] 266721 0
H-2011-0044

Summary
Brief summary
Around 30-50% of adults will experience neck pain over a 12 month period, and many are treated with manual therapy. Although evidence supports manual therapy treatment when combined with exercise, the dose is not defined. Up until now, there were few methods for objectively quantifying a manual technique to establish its optimal dose. This pilot randomised controlled trial will investigate two specific doses of posterior-to-anterior (PA) mobilisation, the most common manual technique therapists use when treating the cervical spine. Sixty patients will be randomised to receive either a high force or low force PA mobilisation, or sham treatment, with patients’ pressure pain threshold, resting pain, cervical range and stiffness measured before, immediately after and 3-5 days post-treatment. We will utilise innovative equipment we developed to standardise the manually applied forces, conducting the trial using demonstrable methods from our previous research. Determining dose-response relationships for manual therapy is essential for establishing optimal treatment strategies for patients with neck pain. The cost of neck pain is increasing, and many patients do not achieve symptom resolution. Therefore there is an urgent need for physiotherapists to provide effective treatment dosages with demonstrated patient outcomes, impacting spinal pain and advancing physiotherapy as the preferred treatment choice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32386 0
Address 32386 0
Country 32386 0
Phone 32386 0
Fax 32386 0
Email 32386 0
Contact person for public queries
Name 15633 0
Suzanne Snodgrass
Address 15633 0
School of Health Sciences
Faculty of Health
The University of Newcastle
Hunter Building
Callaghan NSW 2308
Country 15633 0
Australia
Phone 15633 0
+61 24921 2089
Fax 15633 0
+61 2 4921 7053
Email 15633 0
[email protected]
Contact person for scientific queries
Name 6561 0
same
Address 6561 0
School of Health Sciences Faculty of Health The University of Newcastle Hunter Building Callaghan NSW 2308
Country 6561 0
Australia
Phone 6561 0
+61 2 49212089
Fax 6561 0
Email 6561 0
[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

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