Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000503325
Ethics application status
Approved
Date submitted
11/08/2008
Date registered
30/09/2008
Date last updated
11/09/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A New Light on Wound Pain:
A Proof of Concept Study of the Effect of Low Intensity Laser Therapy (LILT)
Scientific title
A Proof of Concept Study of the Effect of Low Intensity Laser Therapy (LILT) in the Management of Wound Pain
Secondary ID [1] 724 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound Pain 3530 0
Wound Healing 3723 0
Condition category
Condition code
Other 3682 3682 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The present study aims to examine the potential of Low Intensity Laser Therapy (LILT) to reduce unresolved pain experienced by clients who are receiving home nursing care for chronic wounds. The two treatment groups will receive, in addition to best practice wound pain management, one of two LILT treatment options – a Hand Held Laser device, or the Scanning Laser for up to six weeks or less if problem resolved. The Scanning Laser is a free standing Scanning Laser emitting 2 wavelengths of 655nm visible red light with a power output of 50mW and 810nm infra red laser energy, with a power output of 500mW. The Hand Held Laser is a 12 diode hand held cluster laser consisting of 4 X 655nm visible red light with a power output of 5mW and 4X 655nm visible red light at 40mW power and 4X 785nm infra red laser energy at 55mW power. The LILT group will receive three LILT sessions per week. The duration of each session depends on the type of wound and Laser device.
Intervention code [1] 3246 0
Treatment: Other
Comparator / control treatment
The control group will continue to receive best practice wound pain management as delivered in the home care environment.
Control group
Active

Outcomes
Primary outcome [1] 4592 0
Clients rating of the pain using pain assessment tools including the Brief Pain Inventory.
Timepoint [1] 4592 0
12 weeks after randomisation
Secondary outcome [1] 8095 0
Wound healing rate/per day (cm2)
Timepoint [1] 8095 0
12 weeks after randomisation

Eligibility
Key inclusion criteria
1-The client has a chronic wound on entire leg (of a maximum size of 10cms in diameter and depth of 2cm) which may be of a diabetic origin, pressure ulcer, venous, arterial and mixed aetiology ulcers
2.The wound is older than six weeks from its inception.
3.Wound healing is by secondary intention; “Wound healing is delayed and occurs by a process of granulation, contraction and epithelialisation (Carville, 2001)”

Unresolved Pain
The client reports unresolved pain:

4. The client has pain associated with a chronic wound that has not responded to standard pain management.
4.1. Pain is measured on a pain scale of 0-10 with 0 indicating the absence of pain and 10 indicating the worst pain the client can imagine. Clients are eligible if they report pain as being 1 or more on this scale.
4.2. Pain is to be evaluated as unresolved if any level of pain (1 or greater on the pain scale) persists after they have received pain management.
5. The pain must be located within the wound (plus or minus pain in areas other than the wound i.e. the leg or associated with the wound i.e. when walking the wound is painful).
6. The pain is experienced at times other than during dressing changes.
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The client has been diagnosed with and/or is receiving treatment for a malignancy
2. The client’s health professional or appropriate wound specialist does not support the inclusion of the client in the Randomised Control Trial.
3. Client is on a fee for service program inappropriate for inclusion in the study.
4. The client has any planned absences over the coming three months.
5. Client does not agree to attend the Care and Assessment Centre three times weekly (two times weekly for control group) for six weeks and for 2 weekly review at 8, 10 and 12 weeks.

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)
Both the clinician and client are blinded to study allocation upon consenting to participate in the study. Allocation is concealed and clinicians will contact the central randomisation to get randomisation number and the group client is randomised to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence used for participant randomisation is generated using the random number function in Excel Microsoft software (i.e., computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3713 0
Charities/Societies/Foundations
Name [1] 3713 0
William Buckland Foundation
Country [1] 3713 0
Australia
Primary sponsor type
Other
Name
Royal District Nursing Service (RDNS) Helen Macpherson Smith Institute of Community Health
Address
31 Alma Rd, St Kilda, VIC 3182
Country
Australia
Secondary sponsor category [1] 3330 0
None
Name [1] 3330 0
Address [1] 3330 0
Country [1] 3330 0
Other collaborator category [1] 366 0
Commercial sector/Industry
Name [1] 366 0
Australian Institute of Laser Therapy
Address [1] 366 0
12 Morrison Place, East Melbourne, VIC 3002
Country [1] 366 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5768 0
Royal District Nursing Service Research Ethics Commitee
Ethics committee address [1] 5768 0
Ethics committee country [1] 5768 0
Australia
Date submitted for ethics approval [1] 5768 0
Approval date [1] 5768 0
23/10/2007
Ethics approval number [1] 5768 0
180

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

Contacts
Principal investigator
Name 28825 0
Address 28825 0
Country 28825 0
Phone 28825 0
Fax 28825 0
Email 28825 0
Contact person for public queries
Name 11982 0
Terry Gliddon
Address 11982 0
Royal District Nursing Service, 31 Alma rd. St Kilda, VIC 3182
Country 11982 0
Australia
Phone 11982 0
(03) 95365269
Fax 11982 0
Email 11982 0
[email protected]
Contact person for scientific queries
Name 2910 0
Terry Gliddon
Address 2910 0
Royal District Nursing Service, 31 Alma Rd. St Kilda, VIC 3182
Country 2910 0
Australia
Phone 2910 0
(03) 95365269
Fax 2910 0
Email 2910 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.