Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000752763
Ethics application status
Approved
Date submitted
4/07/2013
Date registered
5/07/2013
Date last updated
5/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring hamstrings flexion-relaxation phenomenon in experimental low back pain
Scientific title
Does experiential low back pain in normal healthy participants change the hamstring flexion-relaxation response?
Secondary ID [1] 282732 0
None
Universal Trial Number (UTN)
U1111-1144-9562
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 289466 0
Condition category
Condition code
Musculoskeletal 289779 289779 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two injections of 0.4 ml of hypertonic saline in lumbar erector spinae muscles (3 cm from mid-line) will be injected to induce experimental low back pain; one in the right lumbar ES and the other in left lumbar ES.
Intervention code [1] 287461 0
Treatment: Other
Comparator / control treatment
Data will be collected in healthy individual before and after inducement of pain with hypertonic saline injections in lumbar erector spinae muscles
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289863 0
Measurement of electrical activity (EMG) in hamstring muscles during trunk flexion with experimental pain to lumbar erector spinae
Timepoint [1] 289863 0
At each phase of trunk flexion before and after injection of hypertonic saline
Primary outcome [2] 289864 0
Range of lumbar flexion by taking photographs from side and measuring angle of lumbar flexion by using a software (Image J)
Timepoint [2] 289864 0
While standing erect and in full flexion position both before and after injection of hypertonic saline
Secondary outcome [1] 303607 0
nil
Timepoint [1] 303607 0
nil

Eligibility
Key inclusion criteria
Age 18-55 years
Ability to give written, informed consent
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Orthopedic or neurological disorders of low back or thigh
Pain on the day of testing
Use of pain medication on the day of testing
Recent trauma to lower back or leg
Unusually elevated hamstring muscle activity which manifests as limited lumbopelvic rotation (assessed on case-by-case basis)
Any pain related condition may be grounds for exclusion
Score >24 on Pain Catastrophising Scale (PCS)
Somatic hypervigilance as indicated by score >7 on Modified Somatic Pain Questionnnaire (MSPQ)
Diagnosis of hemophilia or other clotting disorders
Allergy to latex products
Non New Zealand citizens or residents (due to insurance issues)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
ANOVA

An estimated effect size of 1.7 was used from Zedka’s research for power calculations with alpha at 0.05 and beta at 0.8 which provided required sample of 5 participants. Given response in hamstring muscles is not expected to be as pronounced as that of lumbar erector spinae muscles, target sample was doubled to 10.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2013
Actual
Date of last participant enrolment
Anticipated
29/07/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 5163 0
New Zealand
State/province [1] 5163 0
Auckland

Funding & Sponsors
Funding source category [1] 287506 0
University
Name [1] 287506 0
Unitec Institute of Technology, New Zealand
Country [1] 287506 0
New Zealand
Primary sponsor type
University
Name
Unitec
Address
139 Carrington Road, Mt Albert
Auckland
Country
New Zealand
Secondary sponsor category [1] 286244 0
None
Name [1] 286244 0
None
Address [1] 286244 0
None
Country [1] 286244 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289482 0
Unitec Research Ethics Committee (UREC)
Ethics committee address [1] 289482 0
Ethics committee country [1] 289482 0
New Zealand
Date submitted for ethics approval [1] 289482 0
Approval date [1] 289482 0
Ethics approval number [1] 289482 0

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

Contacts
Principal investigator
Name 41030 0
Mr Gajanan Deshmukh
Address 41030 0
Gajanan Deshmukh
Unitec Institute of Technology
3/12 Quona Avenue
Mt. Roskill
Auckland 1041
Country 41030 0
New Zealand
Phone 41030 0
+64 9 6264692
Fax 41030 0
Email 41030 0
[email protected]
Contact person for public queries
Name 41031 0
Gajanan Deshmukh
Address 41031 0
Gajanan Deshmukh
Unitec Institute of Technology
3/12 Quona Avenue
Mt. Roskill
Auckland 1041
Country 41031 0
New Zealand
Phone 41031 0
+64 9 6264692
Fax 41031 0
Email 41031 0
[email protected]
Contact person for scientific queries
Name 41032 0
Jamie Mannion
Address 41032 0
Jamie Mannion
Unitec Institute of Technology
Building 41, room 1018
139 Carrington Road
Mt. Albert, Auckland 1025
New Zealand
Country 41032 0
New Zealand
Phone 41032 0
+64210629007
Fax 41032 0
Email 41032 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.