Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000682640
Ethics application status
Approved
Date submitted
20/06/2014
Date registered
27/06/2014
Date last updated
30/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Spinal Manipulation upon Local and Remote Deep and Superficial Pain Perception
Scientific title
The Effect of Spinal Manipulation upon Local and Remote Deep and Superficial Pain Perception in Asymptomatic Adults
Secondary ID [1] 284846 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain intensity 292239 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292575 292575 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Side posture spinal manipulation commonly referred to as a hypothenar transverse push procedure will be applied unilaterally to the L5 region of ther lumbar spine. The manipulation will be provided by an experienced chiropractor with 15 years of clinical experience. The duration of the procedure is approximately 1 minute and will be performed once.
Intervention code [1] 289642 0
Treatment: Other
Comparator / control treatment
Comparing the effect of lumbar spinal manipulation when applied to either the left or right hand side of the spine. One group will receive the manipulation on the right (group 1) and one group will receive the manipulation on the left (group 2).
Control group
Active

Outcomes
Primary outcome [1] 292438 0
Pressure pain thresholds will be measured using a Wagner pressure algometer 2cm inferior and lateral to the root of the spine of the scapula, over the belly of the infraspinatus muscle bilaterally.
Timepoint [1] 292438 0
Immediately, 10 minutes, 20 minutes and 30 minutes after administration of intervention
Primary outcome [2] 292490 0
Pressure pain thresholds will be measured using a Wagner pressure algometer 2cm lateral to the L5 spinous process bilaterally.
Timepoint [2] 292490 0
Immediately, 10 minutes, 20 minutes and 30 minutes after administration of intervention
Primary outcome [3] 292491 0
Pressure pain thresholds will be measured using a Wagner pressure algometer at the mid-point of the medial head of the gastrocnemius muscle bilaterally.
Timepoint [3] 292491 0
Immediately, 10 minutes, 20 minutes and 30 minutes after administration of intervention
Secondary outcome [1] 308945 0
Pinprick sensitivity will be determined using the Neuropen whereby a constant 40g pressure is applied to the skin and the participant rates their perceived sharpness on an 11 point numerical pain rating scale 2cm inferior and lateral to the root of the spine of the scapula, over the belly of the infraspinatus muscle bilaterally.
Timepoint [1] 308945 0
Immediately, 10 minutes, 20 minutes and 30 minutes after administration of intervention
Secondary outcome [2] 309091 0
Pinprick sensitivity will be determined using the Neuropen whereby a constant 40g pressure is applied to the skin and the participant rates their perceived sharpness on an 11 point numerical pain rating scale 2cm lateral to the L5 spinous process bilaterally
Timepoint [2] 309091 0
Immediately, 10 minutes, 20 minutes and 30 minutes after administration of intervention
Secondary outcome [3] 309092 0
Pinprick sensitivity will be determined using the Neuropen whereby a constant 40g pressure is applied to the skin and the participant rates their perceived sharpness on an 11 point numerical pain rating scale at the mid-point of the medial head of the gastrocnemius muscle.
Timepoint [3] 309092 0
Immediately, 10 minutes, 20 minutes and 30 minutes after administration of intervention

Eligibility
Key inclusion criteria
No current chronic pain condition
No current acute or sub-acute painful condition affecting the lumbar spine
No contraindications to spinal manipulation
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any rheumatologic disease
Currently receiving anticoagulant therapy
Has taken pain-relieving medication in the previous 24 hours
Alcohol intake within the last 12 hours
Suffers a neurological condition

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)
The group assignment will be placed in sequentially numbered, opaque, sealed, envelopes. The researcher who will apply the intervention, will use these envelopes to allocate participants to their respective groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Upon meeting the criteria outlined in section, participants will be randomly assigned to a group. Using a random number generator a randomisation list consisting of equal numbers of 1s and 2s representing the group allocation will be created by a researcher not taking outcomes measures or applying the intervention. The group assignment will be placed in sequentially numbered, opaque, sealed, envelopes. The researcher who will apply the intervention, will use these envelopes to allocate participants to their respective groups. Group 1 will receive the intervention on the right, while group 2 will receive the intervention on the left.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2014
Actual
27/10/2014
Date of last participant enrolment
Anticipated
31/01/2015
Actual
26/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289458 0
University
Name [1] 289458 0
Murdoch University
Country [1] 289458 0
Australia
Primary sponsor type
Individual
Name
Barrett Losco
Address
Murdoch University
South Street
Murdoch
Western Australia
Australia
6150
Country
Australia
Secondary sponsor category [1] 288145 0
None
Name [1] 288145 0
Address [1] 288145 0
Country [1] 288145 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291217 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 291217 0
Ethics committee country [1] 291217 0
Australia
Date submitted for ethics approval [1] 291217 0
27/06/2014
Approval date [1] 291217 0
24/07/2014
Ethics approval number [1] 291217 0
2014/141

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49370 0
Dr Barrett Losco
Address 49370 0
Murdoch University
South Street
Murdoch
Western Australia
Australia
6150
Country 49370 0
Australia
Phone 49370 0
+61 08 9360 6913
Fax 49370 0
Email 49370 0
[email protected]
Contact person for public queries
Name 49371 0
Barrett Losco
Address 49371 0
Murdoch University
South Street
Murdoch
Western Australia
Australia
6150
Country 49371 0
Australia
Phone 49371 0
+61 08 9360 6913
Fax 49371 0
Email 49371 0
[email protected]
Contact person for scientific queries
Name 49372 0
Barrett Losco
Address 49372 0
Murdoch University
South Street
Murdoch
Western Australia
Australia
6150
Country 49372 0
Australia
Phone 49372 0
+61 08 9360 6913
Fax 49372 0
Email 49372 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.