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Trial registered on ANZCTR


Registration number
ACTRN12614000804684
Ethics application status
Approved
Date submitted
22/07/2014
Date registered
29/07/2014
Date last updated
8/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Spinal Manipulative Therapy on Non-Specific (Mechanical) Neck Pain
Scientific title
The effect of cervical spinal manipulative therapy on neck pain in an adult population with non-specific neck pain.
Secondary ID [1] 284991 0
Nil
Universal Trial Number (UTN)
U-1111-1159-3297
Trial acronym
The SMT Neck Pain Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific neck pain 292496 0
Condition category
Condition code
Musculoskeletal 292805 292805 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 292922 292922 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Stretching & MAM
Group 2: Stretching & IAM
Group 3: Stretching

Group one (standard care): a series of active cervical range of motion stretches held for 30sec, repeated 3 times in six different directions for a total of 5 minutes in addition to one high-velocity, low-amplitude manually applied manipulation (MAM) administered on a single occasion to the cervical spine.

Group two (comparison intervention): stretching routine as described above in addition to one instrument applied manipulation (IAM) administered on a single occasion to the cervical spine. IAM will be delivered using an Activator IV instrument which delivers a measurable force to the desired target (in this instance the lower cervical spine).
Intervention code [1] 289823 0
Treatment: Other
Comparator / control treatment
Group three (control): a series of active cervical range of motion stretches held for 30sec, repeated 3 times in six different directions for a total of 5 minutes.
Control group
Active

Outcomes
Primary outcome [1] 292658 0
Changes to pressure pain thresholds in the neck (algometer).
Timepoint [1] 292658 0
Immediately prior to intervention and at 5min post-intervention.
Primary outcome [2] 292659 0
Changes in neck pain (VAS questionnaire).
Timepoint [2] 292659 0
Immediately prior to intervention and at 5min post-intervention.
Secondary outcome [1] 309429 0
Neck range of motion (inclinometer).
Timepoint [1] 309429 0
Immediately prior to intervention and at 5min post-intervention.
Secondary outcome [2] 309430 0
Hand grip strength (dynamometer).
Timepoint [2] 309430 0
Immediately prior to intervention and at 5min post-intervention.
Secondary outcome [3] 309431 0
Changes in blood pressure at the wrist (sphygmomanometer).
Timepoint [3] 309431 0
Immediately prior to intervention and at 5min post-intervention.

Eligibility
Key inclusion criteria
Non-specific neck pain originating from the lower cervical spine (C5-7).
Minimum age
18 Years
Maximum age
35 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to cervical spinal manipulation.

Pregnancy.

Pre-existing condition which may alter the effect of spinal manipulation e.g. connective tissue disorders.

Neck pain which is not of mechanical origin.

Neck pain that does not originate from the lower cervical spine (C5-7).

Having received cervical spinal manipulation within the preceding one month.

Current use of anticoagulant therapy.

History of recent surgery or recent neck trauma.

Facial or intra-oral anaesthesia or parasthesia.

Visual disturbances, blurred vision or diplopia.

Dizziness/vertigo.

Nausea, tinnitus, drop attacks, dysarthria or dysphagia.

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)
Once the volunteer has successfully completed the screening procedure, provided a medical history and satisfied the inclusion criteria they will be enrolled as a participant in the trial. A participant will then receive a trial specific identification number and be randomly allocated to one of the three trial groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be generated using a computer generated randomisation sequence provided by an administrative officer in the Department of Chiropractic. That person will have no other involvement in the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Single-blinded, randomised controlled clinical trial.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Calculation of sample size was based on the following: detecting a difference of 0.4 units in pressure pain threshold levels, a standard deviation of 0.4, comparison of 2 means, an alpha of 0.05, and a desired power (beta) of 80%. These assumptions generated a sample size of 21 participants per group.

Data analysis will include application of the T-test to compare between the interventions.

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] 9661 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 289605 0
University
Name [1] 289605 0
Macquarie University.
Address [1] 289605 0
Department of Chiropractic
Balaclava Rd
MACQUARIE UNIVERSITY, NSW, 2109.
Country [1] 289605 0
Australia
Primary sponsor type
Individual
Name
Dr Roger Engel
Address
Department of Chiropractic
Balaclava Rd
Macquarie University, NSW, 2109
Country
Australia
Secondary sponsor category [1] 288288 0
Individual
Name [1] 288288 0
Miss Lindsay Gorrell
Address [1] 288288 0
Department of Chiropractic
Balaclava Rd
Macquarie University, NSW, 2109
Country [1] 288288 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291341 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 291341 0
Level 3, Research HUB, C5C
Macquarie University, NSW 2109
Ethics committee country [1] 291341 0
Australia
Date submitted for ethics approval [1] 291341 0
07/03/2014
Approval date [1] 291341 0
21/07/2014
Ethics approval number [1] 291341 0
5201400281

Summary
Brief summary
The aim of this project is to measure the effect of cervical spinal manipulation on people with non-specific neck pain. The research question relates to whether the magnitude of force of a manipulation influences the extent of effect. The project is a single-blinded randomised controlled clinical trial with three equal groups: one control and two intervention. Sixty-three participants, between the ages of 18 and 35 years with a history of non-specific neck pain originating from the lower cervical spine will be randomly allocated to one of three groups. Group 1 (standard care) will receive a single standardized 5-minute neck stretching exercise routine plus a single manually applied manipulation of the cervical spine. Group 2 (comparison intervention) will receive the same stretching program plus a single instrument applied manipulation to the cervical spine. Group 3 (control) will only receive the stretching program. Outcome measures include changes in neck pain, cervical range of motion, hand grip-strength and blood pressure.
Trial website
Trial related presentations / publications
It is intended that results obtained in this trial will be disseminated at scientific conferences.
Public notes

Contacts
Principal investigator
Name 49974 0
Dr Roger Engel
Address 49974 0
Department of Chiropractic
Balaclava Rd
Macquarie University, NSW, 2109
Country 49974 0
Australia
Phone 49974 0
+61 2 9850 6387
Fax 49974 0
+61 2 9850 9389
Email 49974 0
roger.engel@mq.edu.au
Contact person for public queries
Name 49975 0
Miss Lindsay Gorrell
Address 49975 0
Department of Chiropractic
Balaclava Rd
Macquarie University, NSW, 2109
Country 49975 0
Australia
Phone 49975 0
+61 415 209 610
Fax 49975 0
Email 49975 0
lindsay.gorrell@students.mq.edu.au
Contact person for scientific queries
Name 49976 0
Miss Lindsay Gorrell
Address 49976 0
Department of Chiropractic
Balaclava Rd
Macquarie University, NSW, 2109
Country 49976 0
Australia
Phone 49976 0
+61 415 209 610
Fax 49976 0
Email 49976 0
lindsay.gorrell@students.mq.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