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Trial registered on ANZCTR
Registration number
ACTRN12615000230550
Ethics application status
Approved
Date submitted
24/02/2015
Date registered
12/03/2015
Date last updated
12/03/2015
Type of registration
Retrospectively registered
Titles & IDs
Public title
Efficacy of strain-counterstrain technique to produce immediate changes in pressure pain thresholds in tender points at the elbow
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Scientific title
The efficacy of strain-counterstrain technique to produce changes in pressure pain thresholds and pain intensity as reported by VAS in adults with palpable tender points at the elbow
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Secondary ID [1]
286260
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Nil
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Universal Trial Number (UTN)
U1111-1167-5993
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tender points at elbow
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Condition category
Condition code
Musculoskeletal
294641
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0
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Other muscular and skeletal disorders
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Physical Medicine / Rehabilitation
294712
294712
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Single application of strain-counterstrain an osteopathic technique.
The treatment lasted for about 5 minutes. The treatment was administered by a trained manual therapist with over 10 years experience using strain counterstrain.
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Intervention code [1]
291276
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Rehabilitation
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Intervention code [2]
291279
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Treatment: Other
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Comparator / control treatment
Single application of sham strain-counterstrain an osteopathic technique.
The practitioner placed the subjects arm in a position where no change in pain intensity was reported on palpation and no noticeable change in tissue tension was observed by palpation over the tenderpoint. The procedure lasted for about 5 minutes.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Pressure pain threshold
Was measured using a mechanical pressure algometer (Activator Methods Algometer, Activator Methods International Ltd, Phoenix AZ)
Downwards pressure applied perpendicular to skin at marked tenderpoint.
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Assessment method [1]
294403
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Timepoint [1]
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Immediate
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Primary outcome [2]
294404
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Pain intensity VAS
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Assessment method [2]
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Timepoint [2]
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Immediate
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Secondary outcome [1]
313207
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Pain-free grip strength
Was measured using a strain gauge hand dynamometer (Smedley's Dynamometer, TTM, Tokyo)
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Assessment method [1]
313207
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Timepoint [1]
313207
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Immediate
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Eligibility
Key inclusion criteria
Aged 18-65 years
Current palpable tender point in elbow region
Able to understand English language
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Signs or symptoms of cervical radiculopathy
Presence of medical condition that could interfere with the therapy
History of long-term steroid usage
Use of analgesics in previous 24 hours
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All subjects who met inclusion criteria were randomised to either the intervention group or the sham group. Allocation was concealed from research assistant and participant. Allocation concealed by use of sealed opaque envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Single block randomisation schedule generated prior to enrolment using an Internet-based computer programme (www.randomization.com) set for the target number of participants.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
Immediate Pre- Post intervention analysis no follow-up period.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Within-group differences assessed with paired t-tests. Between-group differences assessed with independent t-tests. Analysis of effect sizes by magnitude-based inferences.
Prior to the study, calculations showed that a sample size of 10 participants per group would be required to detect a change in VAS of an effect size of 1.2 assuming 80% statistical
power and alpha = 5%. An additional 2 participants per group was targeted to allow for possible withdrawals from the study.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
19/02/2007
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Actual
19/02/2007
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Date of last participant enrolment
Anticipated
18/03/2007
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Actual
18/03/2007
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
6688
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Funding source category [1]
290820
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Other
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Name [1]
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Unitec Institute of Technology
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Address [1]
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Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
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Country [1]
290820
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New Zealand
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Primary sponsor type
Other
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Name
Unitec Institute of Technology
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Address
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
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Country
New Zealand
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Secondary sponsor category [1]
289505
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None
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Name [1]
289505
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Address [1]
289505
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Country [1]
289505
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
292442
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Unitec Research Ethics Committee
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Ethics committee address [1]
292442
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Research Office and Postgraduate Centre
Unitec Institute of Technology
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
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Ethics committee country [1]
292442
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New Zealand
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Date submitted for ethics approval [1]
292442
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14/08/2006
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Approval date [1]
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01/09/2006
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Ethics approval number [1]
292442
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2006-611.
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Summary
Brief summary
To assess the efficacy of the immediate effects of a single application of an osteopathic technique, strain-counterstrain, on pressure pain thresholds and pain intensity in subjects with elbow pain.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr James Hutchinson
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Address
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Unitec Institute of Technology Carrington Rd, Mt Albert Private Bag 92025 Victoria Street West Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 815 4321 x7914
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Fax
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Email
54690
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[email protected]
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Contact person for public queries
Name
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Mr James Hutchinson
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Address
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Unitec Institute of Technology Carrington Rd, Mt Albert Private Bag 92025 Victoria Street West Auckland 1142
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Country
54691
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New Zealand
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Phone
54691
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+64 9 815 4321 x7914
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Fax
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Email
54691
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[email protected]
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Contact person for scientific queries
Name
54692
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Mr James Hutchinson
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Address
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Unitec Institute of Technology Carrington Rd, Mt Albert Private Bag 92025 Victoria Street West Auckland 1142
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Country
54692
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New Zealand
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Phone
54692
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+64 9 815 4321 x7914
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Fax
54692
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Email
54692
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[email protected]
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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.
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