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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
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
Secondary ID [1] 286260 0
Nil
Universal Trial Number (UTN)
U1111-1167-5993
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tender points at elbow 294323 0
Condition category
Condition code
Musculoskeletal 294641 294641 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 294712 294712 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 291276 0
Rehabilitation
Intervention code [2] 291279 0
Treatment: Other
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.
Control group
Placebo

Outcomes
Primary outcome [1] 294403 0
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.
Timepoint [1] 294403 0
Immediate
Primary outcome [2] 294404 0
Pain intensity VAS
Timepoint [2] 294404 0
Immediate
Secondary outcome [1] 313207 0
Pain-free grip strength
Was measured using a strain gauge hand dynamometer (Smedley's Dynamometer, TTM, Tokyo)
Timepoint [1] 313207 0
Immediate

Eligibility
Key inclusion criteria
Aged 18-65 years
Current palpable tender point in elbow region
Able to understand English language
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Immediate Pre- Post intervention analysis no follow-up period.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6688 0
New Zealand
State/province [1] 6688 0
Auckland

Funding & Sponsors
Funding source category [1] 290820 0
Other
Name [1] 290820 0
Unitec Institute of Technology
Address [1] 290820 0
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
Country [1] 290820 0
New Zealand
Primary sponsor type
Other
Name
Unitec Institute of Technology
Address
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 289505 0
None
Name [1] 289505 0
Address [1] 289505 0
Country [1] 289505 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292442 0
Unitec Research Ethics Committee
Ethics committee address [1] 292442 0
Research Office and Postgraduate Centre
Unitec Institute of Technology
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
Ethics committee country [1] 292442 0
New Zealand
Date submitted for ethics approval [1] 292442 0
14/08/2006
Approval date [1] 292442 0
01/09/2006
Ethics approval number [1] 292442 0
2006-611.

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54690 0
Mr James Hutchinson
Address 54690 0
Unitec Institute of Technology Carrington Rd, Mt Albert Private Bag 92025 Victoria Street West Auckland 1142
Country 54690 0
New Zealand
Phone 54690 0
+64 9 815 4321 x7914
Fax 54690 0
Email 54690 0
jhutchinson@unitec.ac.nz
Contact person for public queries
Name 54691 0
Mr James Hutchinson
Address 54691 0
Unitec Institute of Technology Carrington Rd, Mt Albert Private Bag 92025 Victoria Street West Auckland 1142
Country 54691 0
New Zealand
Phone 54691 0
+64 9 815 4321 x7914
Fax 54691 0
Email 54691 0
jhutchinson@unitec.ac.nz
Contact person for scientific queries
Name 54692 0
Mr James Hutchinson
Address 54692 0
Unitec Institute of Technology Carrington Rd, Mt Albert Private Bag 92025 Victoria Street West Auckland 1142
Country 54692 0
New Zealand
Phone 54692 0
+64 9 815 4321 x7914
Fax 54692 0
Email 54692 0
jhutchinson@unitec.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary