Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000129785
Ethics application status
Approved
Date submitted
29/01/2013
Date registered
1/02/2013
Date last updated
25/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
To what extent does experimentally induced pain affect the mental rotation of body parts and non-body objects in healthy participants?
Scientific title
To what extent does experimentally induced pain affect the mental rotation of body parts and non-body objects in healthy participants?
Secondary ID [1] 281853 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Experimentally induced acute pain (intramuscular hypertonic saline injections) and laterality recognition 288215 0
Condition category
Condition code
Physical Medicine / Rehabilitation 288580 288580 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo 4 separate intramuscular injections of 5% hypertonic saline solution into their upper limbs (no therapeutic benefit) over 2 sessions.
There will be 2 injections per session, and the sessions will seperated by at least 1 week. The first injection in a session will be followed by the second injection by approximately 35 minutes (this time frame includes a laterality task during pain, a washout period of 10 mins, a post-pain laterality task, and a pre-pain laterality task).

Injection sites are bilateral thenar eminences and bilateral common extensor origin (CEO) on the lateral upper forearm area. Each site will be injected once. The same bilateral locations will be injection during 1 session - eg R and L thenar eminences or R and L CEO.

Participants complete a laterality recognition task before, during and after the painful stimulus. The laterality task is a computer based time response measurement programme which displays pictures of hands, feet and cars of different laterality (handedness) which have been rotated around different axes. Participants judge the laterality of each picture and input their response using the arrow keys on a keyboard. The task takes 7.5 minutes to complete when all pictures are displayed twice. The programme is also designed to ask participants to rate their pain levels (VAS) at 20 second intervals. This is also inputted using the arrow keys.
Intervention code [1] 286411 0
Other interventions
Comparator / control treatment
All participants are healthy and receive the same intervention (no therapeutic benefit). Participants used as own controls - pre, during, post painful stimulus.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288737 0
To investigate the effects of experimentally induced hand and elbow pain on the mental rotation of body parts and non-body objects in healthy participants, and assess the reliability of these response patterns.

The tool used to measure this outcome is the laterality task which is a response time measurement programme. The response times during the different pain states (pre, during, post) will be analysed to assess how the average response times change.
The pain ratings are measured using a Visual Analogue Scale measurement, and the pain perceptual characteristics are measured using the McGill pain questionnaire.
Timepoint [1] 288737 0
There are 4 types of data to be collected: demographic data will be collected at least 1 week prior to the first injection. The pain rating and perceptual characteristics and laterality data is collected at the time of injections (detailed below):

- immediately before the injection - the pre-pain laterality and pain rating data is collected.
- immediately after the needle is withdrawn - the during-pain laterality and pain rating data is collected.
- the perceptual characteristics data is collected when the experimentally induced pain has reached 0 (approx. 6-7 mins post needle withdrawl).
- the post-pain and pain rating data is collected following a washout period of 10 mins after the during-pain data collection has finished (at least 17.5mins after the needle has been withdrawn)
Secondary outcome [1] 300865 0
To compare laterality data between exposures (changes in injections sites and sides), and differences in handedness, gender, ethnicity, age (demographic data) and perceptual characteristics of pain.
Timepoint [1] 300865 0
There are 4 types of data to be collected: demographic data will be collected at least 1 week prior to the first injection. The pain rating and perceptual characteristics and laterality data is collected at the time of injections (detailed below):

- immediately before the injection - the pre-pain laterality and pain rating data is collected.
- immediately after the needle is withdrawn - the during-pain laterality and pain rating data is collected.
- the perceptual characteristics data is collected when the experimentally induced pain has reached 0 (approx. 6-7 mins post needle withdrawl).
- the post-pain and pain rating data is collected following a washout period of 10 mins after the during-pain data collection has finished (at least 17.5mins after the needle has been withdrawn)

Eligibility
Key inclusion criteria
Aged 18-50
Ability to speak and write English
Ability to give written, informed consent
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Orthopaedic or neurological disorders of the upper limb or neck
Significant visual impairment
Diagnosis of dyslexia
Pain on the day of testing (chronic or acute)
Use of pain medications on day of testing
Trauma to upper limb
Fracture/dislocation
Open wounds or skin conditions
Pain related conditions: Pain catastrophising (>24 on pain catatrophising scale (PCS) (Pedler, 2010)), Somatic hypervigilance (>7 on modified somatic pain questionnaire (MSPQ) (Donaldson et al., 2011))
History of fainting or seizures
Diagnosis of haemophilia or other clotting disease
Allergy to latex products
Non-New Zealand citizens or residents

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited via notices and volunteers will be initially emailed an information sheet about the experimental pain and the study, and the inclusion/exclusion criteria. If they are still interested they will be be emailed a link to complete the pain conditions questionnaires (exclusion criteria). If suitable and willing, they will meet with NP to discuss the study, ask questions and enroll. From there a time will be arranged to receive the intervention (all participants receive the same intervention).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants will receive the same intervention.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/02/2013
Actual
8/04/2013
Date of last participant enrolment
Anticipated
18/03/2013
Actual
7/05/2013
Date of last data collection
Anticipated
Actual
16/05/2013
Sample size
Target
20
Accrual to date
Final
22
Recruitment outside Australia
Country [1] 4825 0
New Zealand
State/province [1] 4825 0
Auckland

Funding & Sponsors
Funding source category [1] 286633 0
Charities/Societies/Foundations
Name [1] 286633 0
Todd Foundation
2012 Awards for Excellence (Polytechs)
Country [1] 286633 0
New Zealand
Primary sponsor type
University
Name
Unitec, NZ
Address
139 Carrington Rd, Mt Albert, Auckland 1025
Country
New Zealand
Secondary sponsor category [1] 285418 0
None
Name [1] 285418 0
Address [1] 285418 0
Country [1] 285418 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288712 0
Health and Disability Ethics Committees - Northern A
Ethics committee address [1] 288712 0
Ethics committee country [1] 288712 0
New Zealand
Date submitted for ethics approval [1] 288712 0
Approval date [1] 288712 0
17/09/2012
Ethics approval number [1] 288712 0
12/NTA/37

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

Contacts
Principal investigator
Name 37394 0
Ms Nichole Phillips
Address 37394 0
c/o Clinic 41
Unitec Institute of Technology
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
Country 37394 0
New Zealand
Phone 37394 0
+64 9 815 6794
Fax 37394 0
Email 37394 0
[email protected]
Contact person for public queries
Name 37395 0
Nichole Phillips
Address 37395 0
c/o Clinic 41
Unitec Institute of Technology
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
Country 37395 0
New Zealand
Phone 37395 0
+64 9 815 6794
Fax 37395 0
Email 37395 0
[email protected]
Contact person for scientific queries
Name 37396 0
Nichole Phillips
Address 37396 0
c/o Clinic 41
Unitec Institute of Technology
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
Country 37396 0
New Zealand
Phone 37396 0
+64 9 815 6794
Fax 37396 0
Email 37396 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.