Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000039886
Ethics application status
Approved
Date submitted
2/12/2011
Date registered
10/01/2012
Date last updated
10/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Central Sensitization Modulates Low Back Muscle Recruitment Patterns and Perceived Effort During Static Low Back Stabilizing Exercises
Scientific title
The comparison of the effect of central sensitization evoked by topical capsaicin cream versus non-sensitizing placebo cream on the muscle activation patterns in the lumbar spine and perceived effort during static low back stabilizing exercises in young healthy subjects.
Secondary ID [1] 273398 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
central sensitization 279216 0
Condition category
Condition code
Musculoskeletal 279374 279374 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Test group will receive one (1) topical application of capsaicin (Zostrix, 0.075%) to the L1-L5 dermatomes bilaterally. The capsaicin applied to each subject will not be standardized since we are not investigating dose responses; a thin layer of capsaicin will be applied to cover the dorsal skin areas bounded anatomically by the 12 rib line (superiorly), the lateral border of the trunk (laterally) and a transverse line through the posterior superior iliac spine (inferiorly).
Intervention code [1] 283733 0
Treatment: Other
Intervention code [2] 283763 0
Other interventions
Comparator / control treatment
Control group will receive one (1) topical non-sensitizing cream (Biotone) with similar colour and texture to Zostrix. The cream will be applied to the L1-L5 dermatomes bilaterally.The total amount of cream will not be standardized since we are not investigating dose responses; a thin layer of cream will be applied to cover the dorsal skin areas bounded anatomically by the 12 rib line (superiorly), the lateral border of the trunk (laterally) and a transverse line through the posterior superior iliac spine (inferiorly).
Control group
Placebo

Outcomes
Primary outcome [1] 285964 0
EMG muscle activity (amplitude, mean frequency) in erector spinae, internal obliques, gluteus medius
Timepoint [1] 285964 0
A ten (10) second record trial will be collected at baseline (pre-intervention), 10, 20 and 30 minutes post-intervention.
Primary outcome [2] 285965 0
Perceived exertion rating (Borg Scale)
Timepoint [2] 285965 0
baseline (pre-intervention), 10, 20 and 30 minutes post-intervention.
Secondary outcome [1] 294912 0
Pain Rating Scale (Visual Analog Score)
Timepoint [1] 294912 0
baseline (pre-intervention) and 10, 20 and 30 minutes post-intervention
Secondary outcome [2] 294913 0
Brush Allodynia Score. Brush allodynia testing will be done to validate the presence of secondary hyperalgesia (central sensitization). The Brush Allodynia Score is defined as the linear distance from the treatment area (capsaicin, placebo cream) to the outer border of the skin characterized by secondary hyperalgesia.
Timepoint [2] 294913 0
baseline (pre-intervention) and 10, 20 and 30 minutes post-intervention.

Eligibility
Key inclusion criteria
young healthy subjects
Minimum age
20 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The Exclusion Criteria Include neurologic disorders (neuropathy, neurodegenerative conditions), previous history of low back pain (discogenic, mechanical, myofascial), current use of medication (anti-inflammatories, analgesics, anticonvulsants, antidepressants).

History of low back injury (discogenic, mechanical) use of anticoagulant therapy, stroke or TIA, spine trauma, recent (<6 months) motor vehicle accident, lumbar spine surgery, hypertension, focal neurological symptoms (sensory/motor)

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)
Prospective subjects will be required to complete a confidential health questionnaire to identify any exclusionary health conditions. Qualifying subjects will provide informed signed consent prior to commencement.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be performed using a random draw technique. On testing day, a research assistant will draw labelled slip of paper (test, control) from a bin. The same research assistant will be responsible for applying the topical intervention (capsaicin, placebo). Group allocation will be concealed from the primary investigators and will be recorded/stored by the research assistant.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 3952 0
Canada
State/province [1] 3952 0

Funding & Sponsors
Funding source category [1] 284213 0
Self funded/Unfunded
Name [1] 284213 0
Country [1] 284213 0
Primary sponsor type
University
Name
University of Guelph
Address
50 Stone Road
Guelph, ON
N1G 2W1
Country
Canada
Secondary sponsor category [1] 269171 0
None
Name [1] 269171 0
Address [1] 269171 0
Country [1] 269171 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286175 0
University of Guelph Research Ethics Board
Ethics committee address [1] 286175 0
Ethics committee country [1] 286175 0
Canada
Date submitted for ethics approval [1] 286175 0
Approval date [1] 286175 0
04/10/2011
Ethics approval number [1] 286175 0
11JL27

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

Contacts
Principal investigator
Name 33398 0
Address 33398 0
Country 33398 0
Phone 33398 0
Fax 33398 0
Email 33398 0
Contact person for public queries
Name 16645 0
John Srbely , D.C., Ph.D.
Address 16645 0
Department of Human Health and Nutritional Sciences
Room 329A
University of Guelph
Guelph, ON
N1G 2W1
Country 16645 0
Canada
Phone 16645 0
+1, 519, 824-4120 ext. 52058
Fax 16645 0
+1, 519, 763-5902
Email 16645 0
[email protected]
Contact person for scientific queries
Name 7573 0
John Srbely , D.C., Ph.D.
Address 7573 0
Department of Human Health and Nutritional Sciences
University of Guelph
Guelph, ON
N1G 2W1
Country 7573 0
Canada
Phone 7573 0
+1, 519, 824-4120 ext. 52058
Fax 7573 0
+1, 519, 763-5902
Email 7573 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.