Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000417583
Ethics application status
Approved
Date submitted
21/09/2006
Date registered
26/09/2006
Date last updated
26/09/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of manipulation for recent onset neck pain. A randomised controlled trial
Scientific title
A randomised controlled trial to evaluate the efficacy of manipulation in hastening recovery of symptoms and disability in neck pain of recent onset.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute and subacute neck pain 1386 0
Condition category
Condition code
Musculoskeletal 1479 1479 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental group: 4 sessions of neck manipulation of up to 30 minute duration provided by an experienced manipulative physiotherapist or chiropractor over 2 weeks
Intervention code [1] 1369 0
Treatment: Other
Comparator / control treatment
Control group: 4 sessions of neck mobilisation of up to 30 minute duration provided by an experienced manipulative physiotherapist or chiropractor over 2 weeks
Control group
Active

Outcomes
Primary outcome [1] 2051 0
The number of days to recovery of neck pain. Recovery is defined as a pain score of 0 on a 10 point pain scale for 7 consecutive days
Timepoint [1] 2051 0
The participants will keep a daily record of pain scores for 3 months.
Secondary outcome [1] 3532 0
Time to recovery of disability
Timepoint [1] 3532 0
Measured at 12 weeks.
Secondary outcome [2] 3533 0
Neck Disability Index
Timepoint [2] 3533 0
Measured at 12 weeks.
Secondary outcome [3] 3534 0
Patient Specific Functional Scale
Timepoint [3] 3534 0
Measured at 12 weeks.
Secondary outcome [4] 3535 0
SF-12
Timepoint [4] 3535 0
Measured at 12 weeks.
Secondary outcome [5] 3536 0
Global perceived effect.
Timepoint [5] 3536 0
Measured at 12 weeks.

Eligibility
Key inclusion criteria
1) primary complaint of neck pain of <3 months duration preceded by >1month without neck pain, 2) English speaking, 3) neck manipulation is considered a suitable treatment by the treating practitioner.
Minimum age
18 Days
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) neck pain related to whiplash associated disorder or other trauma 2) serious spinal pathology (metastatic, inflammatory or infective diseases of the spine, or fracture) 3) nerve root compromise 4) spinal cord compromise 5) neck surgery in the past 12 months.

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 envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random allocation sequence will be prepared by a statistician who is not involved in subject recruitment or data collection.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessor blinded
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
182
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1618 0
Government body
Name [1] 1618 0
National Health and Medical Research Council project grant
Country [1] 1618 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 1419 0
None
Name [1] 1419 0
nil
Address [1] 1419 0
Country [1] 1419 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3066 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 3066 0
Ethics committee country [1] 3066 0
Australia
Date submitted for ethics approval [1] 3066 0
Approval date [1] 3066 0
Ethics approval number [1] 3066 0
02-2006/3/8758

Summary
Brief summary
Manipulation is a common treatment for non-specific neck pain. Neck manipulation, unlike gentler forms of manual therapy such as mobilisation, is associated with a small risk of serious neurovascular injury and can result in stroke or death. There is long standing and vigorous debate both within and between the professions that practice neck manipulation and the wider scientific community as to whether neck manipulation potentially does more harm than good. Both manipulation and mobilisation, when used in combination with exercise are more effective than placebo or other treatments for subacute and chronic neck pain. It is not known however, if manipulation leads to more rapid or more complete recovery than safer manual therapy techniques for neck pain of recent onset. This randomised controlled trial will compare the effectiveness of manipulation and mobilisation for an episode of recent onset neck pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27596 0
Address 27596 0
Country 27596 0
Phone 27596 0
Fax 27596 0
Email 27596 0
Contact person for public queries
Name 10558 0
Mr Andrew Leaver
Address 10558 0
School of Physiotherapy
Faculty of Health Sciences
PO Box 170
Lidcombe NSW 1825
Country 10558 0
Australia
Phone 10558 0
+61 2 9351 9682
Fax 10558 0
+61 2 9351 9681
Email 10558 0
a.leaver@fhs.usyd.edu.au
Contact person for scientific queries
Name 1486 0
Prof Kathryn Refshauge
Address 1486 0
School of Physiotherapy
Faculty of Health Sciences
PO Box 170
Lidcombe NSW 1825
Country 1486 0
Australia
Phone 1486 0
+61 2 93519262
Fax 1486 0
+61 2 9351 9681
Email 1486 0
k.refshauge@fhs.usyd.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
No additional documents have been identified.