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Trial registered on ANZCTR


Registration number
ACTRN12617000355370
Ethics application status
Approved
Date submitted
2/03/2017
Date registered
8/03/2017
Date last updated
11/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does acupuncture/dry needling treatment improve scar pain and itch in adults with abnormal scars following trauma or surgery?
Scientific title
Does acupuncture/dry needling treatment improve scar pain and itch in adults with abnormal hypertrophic scars following trauma or surgery?
Secondary ID [1] 291297 0
None
Universal Trial Number (UTN)
U1111-1193-5799
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertrophic scars 302263 0
Abnormal Scars 302400 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301858 301858 0 0
Physiotherapy
Skin 301937 301937 0 0
Other skin conditions
Alternative and Complementary Medicine 301938 301938 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Local Acupuncture Group - This treatment group will receive routine care consisting of 5 minutes of scar massage, and a hand-out with general self-management, exercise and post-treatment management advice that has been specifically designed for this trial..
They will also receive 15 minutes of acupuncture treatment applied at 2cm intervals locally around their scar with needle stimulation via bidirectional rotation at 5 and 10 minutes and immediately prior to needle removal.
Treatment will consist of 6 treatments over 4 weeks (2 per week for 2 weeks then 1 per week for 2 weeks).
Acupuncture treatment will be provided by a physiotherapist with 11years experience in private practice physiotherapy including 10 years dry needling and 2 years western acupuncture experience.
Intervention code [1] 297327 0
Treatment: Other
Comparator / control treatment
Distant Acupuncture Group - This treatment group will receive routine care consisting of 5 minutes of scar massage, a hand-out with general self-management, exercise and post-treatment management advice, which is the same as the intervention group.
They will receive 15 minutes of acupuncture treatment with needles placed at distant points in the body that have no neuroanatomical links to the scar being treated. They will receive the same number of needles based on scar size as the intervention group. Needles will be stimulated at 5 and 10 minutes and immediately prior to removal via bidirectional rotation.
Acupuncture treatment points for this group have been selected so that they do not share any neuroanatomical links (eg. spinal segmental nerve innervation). For scars above the umbilicus the following points will be used: bilaterally: 2cm lateral to the spinous process of L3 and L4, midline of the posterior leg 5cm below the knee crease and 5 and 10cm above the knee crease. For scars below the umbilicus the following points will be used bilaterally: 1cm lateral to the spinous process of C7 and T2, the posterior surface of the arm at 5 and 8cm above the elbow and midway down the forearm. If more than 10 needles are required based on scar size measurements, then additional needles will be placed at 2cm intervals from the points used in the limbs, and recorded for consistency between treatments.
Acupuncture treatment will be provided by a physiotherapist with 11years experience in private practice physiotherapy including 10 years dry needling and 2 years western acupuncture experience.
Control group
Active

Outcomes
Primary outcome [1] 301302 0
Patient and Observer Scar Assessment Scale (POSAS) - Patient response component
Timepoint [1] 301302 0
Baseline, at attendance of the 4th session, at final treatment session, and as follow up one and two months following treatment cessation.
Primary outcome [2] 301303 0
Numerical Rating Scale (NRS) for pain
Timepoint [2] 301303 0
Prior to each treatment session (6 times in total)
Primary outcome [3] 301360 0
Numerical Rating Scale (NRS) for itch
Timepoint [3] 301360 0
Prior to each treatment session (6 times in total).
Secondary outcome [1] 332271 0
Short Form-36 (SF-36) Health related quality of life questionnaire
Timepoint [1] 332271 0
Baseline, at attendance of the 4th treatment, at the final treatment, then as follow up at one and two months following treatment cessation.

Eligibility
Key inclusion criteria
* Score of at least 3/10 on numerical rating scale for pain or itch prior to enrolment.
* Scar from 6 weeks to 12 months following injury.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Keloid scar
* Atrophic scar
* Current Pregnancy
* Currently receiving physical scar treatment (massage, acupuncture, injection therapy)
* Unstable Medical conditions (uncontrolled blood pressure, uncontrolled epilepsy)
* Loss of sensation in area to be treated (nerve injury, stroke, diabetic neuropathy)
* Lymphoedema in affected limb
* Allergy to stainless steel
* Needle Phobic
* Not consenting to receive acupuncture
* Individuals who are trained in providing acupuncture

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation using online software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The biostatisticians at The University of Notre Dame Australia calculated the sample size based on a 2 point change on NRS is needed to reject the null hypothesis with probability of 80% and type I error probability of 0.05. 36 experimental and 36 control participants are needed, with 20% extra recruited to allow for drop-outs. The total to be recruited is 86.
Data will be analysed with an intention to treat (ITT) and per protocol analysis for sensitivity analysis. Data will be described using descriptive statistics, and analysed using linear mixed models.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2017
Actual
6/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
86
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment postcode(s) [1] 15484 0
6000 - Perth
Recruitment postcode(s) [2] 15485 0
6160 - Fremantle
Recruitment postcode(s) [3] 22635 0
3000 - Melbourne
Recruitment postcode(s) [4] 22636 0
6152 - Manning

Funding & Sponsors
Funding source category [1] 295764 0
University
Name [1] 295764 0
The School of Physiotherapy, The University of Notre Dame Australia,
Country [1] 295764 0
Australia
Primary sponsor type
Individual
Name
Catherine Smith
Address
School of Physiotherapy
The University of Notre Dame Australia
19 Mouat St
Fremantle
WA 6160
Country
Australia
Secondary sponsor category [1] 294610 0
Individual
Name [1] 294610 0
Dr Dale Edgar
Address [1] 294610 0
School of Physiotherapy
The University of Notre Dame Australia
19 Mouat St
Fremantle
WA 6160
Country [1] 294610 0
Australia
Other collaborator category [1] 279457 0
Individual
Name [1] 279457 0
Ms Susan Kohut
Address [1] 279457 0
School of Clinical Sciences A-11, Auckland University of Technology (AUT)
Private Bag 92005,
Auckland 1142
New Zealand
Country [1] 279457 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297062 0
The University of Notre Dame Australia, Human Research Ethics Committe Fremantle
Ethics committee address [1] 297062 0
Ethics committee country [1] 297062 0
Australia
Date submitted for ethics approval [1] 297062 0
28/02/2017
Approval date [1] 297062 0
04/04/2017
Ethics approval number [1] 297062 0
017029F

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

Contacts
Principal investigator
Name 72846 0
Ms Catherine Smith
Address 72846 0
The School of Physiotherapy
The University of Notre Dame Australia
19 Mouat St
Fremantle
WA 6160
Country 72846 0
Australia
Phone 72846 0
+61 405816942
Fax 72846 0
Email 72846 0
[email protected]
Contact person for public queries
Name 72847 0
Catherine Smith
Address 72847 0
The School of Physiotherapy
The University of Notre Dame Australia
19 Mouat St
Fremantle
WA 6160
Country 72847 0
Australia
Phone 72847 0
+61 405816942
Fax 72847 0
Email 72847 0
[email protected]
Contact person for scientific queries
Name 72848 0
Catherine Smith
Address 72848 0
The School of Physiotherapy
The University of Notre Dame Australia
19 Mouat St
Fremantle
WA 6160
Country 72848 0
Australia
Phone 72848 0
+61 405816942
Fax 72848 0
Email 72848 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

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