Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000544976
Ethics application status
Approved
Date submitted
24/05/2011
Date registered
30/05/2011
Date last updated
26/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Does low level laser therapy reduce pain levels in cracked or grazed nipples in breastfeeding Western Australian women?
Scientific title
Does low level laser therapy reduce pain levels in cracked or grazed nipples in breastfeeding Western Australian women?
Secondary ID [1] 262245 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cracked nipples 267936 0
Condition category
Condition code
Reproductive Health and Childbirth 268082 268082 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low level laser therapy will be used as a treatment for reducing pain in cracked nipples of breastfeeding women.

The laser is a Class 3B single GaAIAs laser. The laser diode has output 100mW, wavelength of 810nm and pulse width of 100microseconds. Illumination is provided by three blue LED’s of 470nm. Elliptical beam area is 9.2mm2 at the aperture.

Treatment doesage is 3Jcm-2, 100% per point. One point is the surface area covered by the laser diode aperture. The number of points treated will be visually determined by the treating physiotherapist, daily, for as many days as is required for each individual.
Intervention code [1] 266634 0
Treatment: Devices
Comparator / control treatment
The control will be a placebo laser diode identical in appearence to the active laser. It will be administered by the blinded treating physiotherapist in the same manner as the active laser treatment will be administered. The number of points of treatment will be visually determined by the treating physiotherapist, daily, for as many days as is required for each individual.
Control group
Placebo

Outcomes
Primary outcome [1] 266820 0
Nipple pain will be measured using the change in pain on the Numerical Rating Scale (NRS). At each occasion of treatment, the physiotherapist will use standardised questioning to request NRS scores. Subjects will be asked to score the pain experienced during the most recent breastfeed and on self-palpation of the nipple immediately before and after intervention.
Timepoint [1] 266820 0
Nipple pain measured before and after treatment at each treatment session.
Secondary outcome [1] 276448 0
Breastfeeding continuation will be investigated with an interview.
Timepoint [1] 276448 0
Baseline, 2 and 8 weeks following first treatment session.
Secondary outcome [2] 276449 0
Subjective improvement of the nipple trauma reported by the subject.
Timepoint [2] 276449 0
Baseline and each treatment session.

Eligibility
Key inclusion criteria
Breastfeeding women with single and multiple births
Women with broken nipple integrity (cracked or grazed nipples) as assessed by the treating physiotherapist
Women who give informed consent to participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are planning to suppress breastfeeding within 2 weeks
Women with babies in the Special Care Nursery
Women who have infants diagnosed with cleft palate
Women with infectious blood diseased (including HIV, AIDS and Hepatitis C)
Women with nipple piercing on the affected side
Women with breast implants, breast augmentation or who have had breast reduction surgery
Women who are expressing only (other than those resting for treatment) and not attempting to breastfeed
Women who have insufficient English skills to understand and comprehend the study and are unable to give informed consent.

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)
Subjects will be recruited from breastfeeding women attending King Edward Memorial Hosptial (Western Australia's public womens hospital). Inpatients or outpatiens who are referred (including self referral) to physiotherapy for laser treatment of cracked or grazed nipples will be invited to particpate in the study.

Once referred for laser therapy, the treating physiotherapist will assess subject eligibility. If criteria are fulfilled subjects will recieve detailed information regarding the study including the aims, duration and methods. Written consent will be sought.

Subjects consenting to particpate in the study will be randomised to either the control or intervention group using block randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Four black envelopes will be grouped, two envelopes containing the letter A and two the letter B. Subjects will select an envelope and receive the corresponding treatment protocol. Once the four envelopes have been allocated the process will be repeated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267130 0
Self funded/Unfunded
Name [1] 267130 0
Country [1] 267130 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Main campus location
Kent Street, Bentley, Perth
Western Australia. 6102.

Postal address
GPO Box U1987, Perth
Western Australia. 6845.
Country
Australia
Secondary sponsor category [1] 264205 0
Hospital
Name [1] 264205 0
King Edward Memorial Hospital
Address [1] 264205 0
374 Bagot Road
Subiaco, Perth
Western Australia
Australia 6008
Country [1] 264205 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267117 0
Curtin University
Ethics committee address [1] 267117 0
Ethics committee country [1] 267117 0
Date submitted for ethics approval [1] 267117 0
07/06/2011
Approval date [1] 267117 0
Ethics approval number [1] 267117 0
HR117/2011

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

Contacts
Principal investigator
Name 32651 0
Address 32651 0
Country 32651 0
Phone 32651 0
Fax 32651 0
Email 32651 0
Contact person for public queries
Name 15898 0
Laura Snowball
Address 15898 0
c/o Judith Thompson
School of Physiotherapy
Curtin University of Technology
GPO Box U1987
Perth, WA 6845
AUSTRALIA
Country 15898 0
Australia
Phone 15898 0
+614 0796 1984
Fax 15898 0
Email 15898 0
[email protected]
Contact person for scientific queries
Name 6826 0
Laura Snowball
Address 6826 0
c/o Judith Thompson
School of Physiotherapy
Curtin University of Technology
GPO Box U1987
Perth, WA 6845
AUSTRALIA
Country 6826 0
Australia
Phone 6826 0
+614 0796 1984
Fax 6826 0
Email 6826 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.