Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000508471
Ethics application status
Approved
Date submitted
27/09/2007
Date registered
5/10/2007
Date last updated
26/08/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Laser Therapy in The Management of Achilles Tendon Injury
Scientific title
Low Level Laser Therapy versus placebo in the management of Achilles tendinopathy using the VISA-A scale as a measure of function.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles Tendinopathy 2403 0
Condition category
Condition code
Musculoskeletal 2506 2506 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eccentric exercise, low level laser therapy
Eccentric exercise; twice daily for 12 weeks.
Laser therapy; 810nm, 100mW, 3J to 6 points around the tendon, 3 times per week for 4 weeks.
Intervention code [1] 2125 0
Treatment: Devices
Comparator / control treatment
The control group will recieve eccentric exercise; twice daily for 12 weeks, and placebo laser therapy 3 times per week for the first 4 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 3432 0
Victorian Institute of Sports Assessment - Achilles (VISA-A) functional questionnaire
Timepoint [1] 3432 0
baseline, 4 weeks, 12 weeks & 52 weeks
Secondary outcome [1] 5658 0
Pain measured on a Visual Analogue Scale(VAS)
Timepoint [1] 5658 0
baseline, 4 weeks, 12 weeks & 52 weeks

Eligibility
Key inclusion criteria
Diagnosis of Achilles tendinopathy and not had any treatment on the Achilles tendon in the previous 3 months
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to Low Level Laser Therapy.
Non-steroidal Anti-inflammatory Drug (NSAID) use.
Insertional Tendinopathy.
Bursitis.
Neurological signs.

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 through advertisements in the local press and from local physiotherapy or GP practices. The principal investigator will assess subjects against inclusion/exclusion criteria and subjects meeting the criteria will be passed on to the clinic receptionist. Concealed allocation will be carried out by the receptionist who asks the patient to draw from 40 sealed opaque envelopes and arranges an appointment with the treating therapist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated list will be used to randomize subjects meeting the inclusion criteria into one of two groups, Laser or Placebo. The clinic administrator will be responsible for randomisation, after the subject has given informed consent. The laser equipment is to be fitted with a switch marked “1” or “2” to indicate placebo or active laser; only the principal investigator will know which position is active. The treating physiotherapist will only be aware that 40 subjects are to receive LLLT at 3J per point, with the laser switched to “1” or “2” as per the treatment sheet.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 609 0
New Zealand
State/province [1] 609 0
Otago

Funding & Sponsors
Funding source category [1] 2653 0
University
Name [1] 2653 0
University of Otago
Country [1] 2653 0
New Zealand
Primary sponsor type
Individual
Name
Steve Tumilty
Address
School of Physiotherapy,
325 Great King Street,
Dunedin
Country
New Zealand
Secondary sponsor category [1] 2401 0
None
Name [1] 2401 0
Address [1] 2401 0
Country [1] 2401 0
Other collaborator category [1] 55 0
Individual
Name [1] 55 0
G.D. Baxter
Address [1] 55 0
School of Physiotherapy,
325 Great King Street,
Dunedin
Country [1] 55 0
New Zealand
Other collaborator category [2] 56 0
Individual
Name [2] 56 0
J.H.Abbott
Address [2] 56 0
School of Physiotherapy,
325 Great King Street,
Dunedin
Country [2] 56 0
New Zealand
Other collaborator category [3] 57 0
Individual
Name [3] 57 0
D.Hurley
Address [3] 57 0
University College Dublin,
Belfield.
Dublin
Country [3] 57 0
Ireland
Other collaborator category [4] 58 0
Individual
Name [4] 58 0
S McDonough
Address [4] 58 0
University of Ulster
Newtownabbey
Co Antrim
Northern Ireland
Country [4] 58 0
United Kingdom
Other collaborator category [5] 59 0
Individual
Name [5] 59 0
J Munn
Address [5] 59 0
School of Physiotherapy,
325 Great King Street,
Dunedin
Country [5] 59 0
New Zealand
Other collaborator category [6] 60 0
Individual
Name [6] 60 0
J Basford
Address [6] 60 0
Mayo Clinic
Rochester
Minnesota
Country [6] 60 0
United States of America
Other collaborator category [7] 483 0
Individual
Name [7] 483 0
L Laakso
Address [7] 483 0
Griffith University, Queensland, Australia
Country [7] 483 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4572 0
Lower South Regional Ethics Committee
Ethics committee address [1] 4572 0
Ministry of Health,
229 Moray Place,
Dunedin
Ethics committee country [1] 4572 0
New Zealand
Date submitted for ethics approval [1] 4572 0
Approval date [1] 4572 0
25/09/2007
Ethics approval number [1] 4572 0
LRS/07/08/032

Summary
Brief summary
The primary aim of this study is to get an idea of whether Low-Level Laser Therapy (LLLT) may be effective in the management of Achilles Tendinopathy, and give benefit to the patients over and above that of eccentric exercises alone. The Hypothesis is that the treatment group will have less pain and more improvement in functional outcome measures score compared to the control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28074 0
Address 28074 0
Country 28074 0
Phone 28074 0
Fax 28074 0
Email 28074 0
Contact person for public queries
Name 11231 0
Steve Tumilty
Address 11231 0
School of Physiotherapy,
325 Great King Street,
Dunedin
Country 11231 0
New Zealand
Phone 11231 0
+64-3-479-4034
Fax 11231 0
+64-3-479-8414
Email 11231 0
[email protected]
Contact person for scientific queries
Name 2159 0
Steve Tumilty
Address 2159 0
School of Physiotherapy,
325 Great King Street,
Dunedin
Country 2159 0
New Zealand
Phone 2159 0
+64-3-479-4034
Fax 2159 0
+64-3-479-8414
Email 2159 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.