ANZCTR - Registration

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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]

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

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

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]

Changes to pressure pain thresholds in the neck (algometer).

Timepoint [1]

Immediately prior to intervention and at 5min post-intervention.

Primary outcome [2]

Changes in neck pain (VAS questionnaire).

Timepoint [2]

Immediately prior to intervention and at 5min post-intervention.

Secondary outcome [1]

Neck range of motion (inclinometer).

Timepoint [1]

Immediately prior to intervention and at 5min post-intervention.

Secondary outcome [2]

Hand grip strength (dynamometer).

Timepoint [2]

Immediately prior to intervention and at 5min post-intervention.

Secondary outcome [3]

Changes in blood pressure at the wrist (sphygmomanometer).

Timepoint [3]

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

Sex

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

4/08/2014

Actual

26/08/2014

Date of last participant enrolment

Anticipated

26/09/2014

Actual

30/09/2014

Date of last data collection

Anticipated

Actual

Sample size

Target

63

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2109 - Macquarie University

Funding & Sponsors

Funding source category [1]

University

Name [1]

Macquarie University.

Address [1]

Department of Chiropractic
Balaclava Rd
MACQUARIE UNIVERSITY, NSW, 2109.

Country [1]

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]

Individual

Name [1]

Miss Lindsay Gorrell

Address [1]

Department of Chiropractic
Balaclava Rd
Macquarie University, NSW, 2109

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University Human Research Ethics Committee

Ethics committee address [1]

Level 3, Research HUB, C5C 
Macquarie University, NSW 2109

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/03/2014

Approval date [1]

21/07/2014

Ethics approval number [1]

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

Dr Roger Engel

Address

Department of Chiropractic
Balaclava Rd
Macquarie University, NSW, 2109

Country

Australia

Phone

+61 2 9850 6387

Fax

+61 2 9850 9389

Email

[email protected]

Contact person for public queries

Name

Lindsay Gorrell

Address

Department of Chiropractic
Balaclava Rd
Macquarie University, NSW, 2109

Country

Australia

Phone

+61 415 209 610

Fax

Email

[email protected]

Contact person for scientific queries

Name

Lindsay Gorrell

Address

Department of Chiropractic
Balaclava Rd
Macquarie University, NSW, 2109

Country

Australia

Phone

+61 415 209 610

Fax

Email

[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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Manual and Instrument Applied Cervical Manipulation for Mechanical Neck Pain: A Randomized Controlled Trial.	2016	https://dx.doi.org/10.1016/j.jmpt.2016.03.003

N.B. These documents automatically identified may not have been verified by the study sponsor.