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Trial registered on ANZCTR


Registration number
ACTRN12613000662763
Ethics application status
Approved
Date submitted
12/06/2013
Date registered
19/06/2013
Date last updated
11/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Eccentric Exercise & Laser Therapy for the Treatment of Achilles Tendinopathy
Scientific title
Examining Outcomes of Pain and Function of Two different Regimes of Eccentric Exercise Combined with Active or Placebo Laser Therapy for the Treatment of Achilles Tendinopathy
Secondary ID [1] 282655 0
Nil
Universal Trial Number (UTN)
U1111-1144-2906
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles Tendinopathy 289355 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289691 289691 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial is a 2X2 factorial design and compares 4 groups.Two of the groups will be prescribed one regimen of exercise, and the other two groups a different regimen of exercise. In addition, two of the groups will receive placebo laser, and the other two groups active laser. The exercise protocol is heavy load eccentric exercise twice per day, 7 days per week for 12 weeks, as per Alfredson et al 1998. Two types of exercise to be used; eccentric loading of the calf muscles with knee straight, and to maximize the activation of the deep calf muscle with the knee bent.
Each of the exercises to include 15 repetitions done in 3 sets (3 X 15 twice per day with knee bent and knee straight).
In the beginning the loading consists of body weight, subjects stand on their toes with all their body weight on the injured leg. The calf muscles are loaded by having the subject lower the heel beneath the forefoot. No following push up onto the toes is allowed; the non-injured leg is used to get back to the start position. Subjects are told to go ahead even if they experience pain and are only allowed to stop if the pain becomes disabling (greater than 4/10 on the visual analogue scale).
When subjects can complete the exercise without pain they must increase the loading by adding extra weight. This can be done by filling a backpack with successively more weight or by using a weight machine.
laser protocol is twice per week for 4 weeks; parameters are 10W output power, pulsed at 100Hz, for 30 Secs, delivering 150J to the medial, lateral and posterior aspects of the Achilles tendon, for a total time of 1:30 min, total energy delivered 450J.
Intervention code [1] 287320 0
Rehabilitation
Intervention code [2] 287321 0
Treatment: Devices
Comparator / control treatment
The comparator heavy load eccentric exercise regime is twice per week for 12 weeks. Two types of exercise to be used; eccentric loading of the calf muscles with knee straight, and to maximize the activation of the deep calf muscle with the knee bent.
Each of the exercises to include 15 repetitions done in 3 sets (3 X 15 twice per day with knee bent and knee straight).
In the beginning the loading consists of body weight, subjects stand on their toes with all their body weight on the injured leg. The calf muscles are loaded by having the subject lower the heel beneath the forefoot. No following push up onto the toes is allowed; the non-injured leg is used to get back to the start position.
Subjects are told to go ahead even if they experience pain and are only allowed to stop if the pain becomes disabling (greater than 4/10 on the visual analogue scale).
When subjects can complete the exercise without pain they must increase the loading by adding extra weight. This can be done by filling a backpack with successively more weight or by using a weight machine.
The control treatment for the laser is placebo laser twice per week for 4 weeks.parameters are 0W output power, pulsed at 100Hz, for 30 Secs, delivering 0J to the medial, lateral and posterior aspects of the Achilles tendon, for a total time of 1:30 min, total energy delivered 0J.
Control group
Placebo

Outcomes
Primary outcome [1] 289785 0
VISA-A questionnaire developed by the Victoria Institute of Sport for the Achilles
Timepoint [1] 289785 0
12 weeks after first treatment
Secondary outcome [1] 303233 0
Numeric Pain Rating Scale NPRS
Timepoint [1] 303233 0
12 weeks after first treatment
Secondary outcome [2] 303234 0
Measurement of tendon thickness using diagnostic ultrasound; measured at the insertion onto the calcaneus, and at the thickest part of the tendon.
Timepoint [2] 303234 0
12 weeks after the first treatment

Eligibility
Key inclusion criteria
Patients with a diagnosis of Achilles Tendinopathy of greater than 3 months standing based upon accepted diagnostic criteria, and assessed by an experienced physiotherapist or physician; and who had not received treatment within the last 3 months. VISA-A score less than 80.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to LLLT to the area of the Achilles tendon; co-morbid musculoskeletal or serious conditions which may confound treatment or anticipated recovery; NSAIDs use; steroid injections or surgery for the condition; insertional tendinopathy or bursitis (retrocalcaneal or Achilles; determined by clinical examination); neurological signs; adverse neural tension affecting the sciatic or sural nerves; VISA-A score greater than 80; symptoms present less than 3 months.

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)
Participants will be recruited into the trial through advertisements in the local media, physiotherapy and GP practices. Once assessed against inclusion and exclusion criteria and accepted into the trial, they will accept one of 80 identical opaque envelopes containing group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation into 4 groups by the clinic receptionist.
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
Factorial
Other design features
Group 1: Placebo laser + eccentric exercise 7 days per week.
Group 2: Active laser + eccentric exercise 7 days per week.
Group 3: Placebo laser + eccentric exercise twice per week.
Group 4: Active laser + eccentric exercise twice per week.
Phase
Phase 3 / Phase 4
Type of endpoint/s
Statistical methods / analysis
Data analysis will be conducted blinded to group allocation on an intention-to-treat and per-protocol basis using SPSS statistical software. Differences between allocation groups at baseline with respect to demographic and clinical variables will be examined to assess the effectiveness of randomization. Analysis of covariance (ANCOVA) using baseline scores as the covariate will be the statistical test used.
From a previous pilot study data,(Tumilty et al 2008) using the change scores at 12 weeks and the participants’ evaluation of what constituted a minimal clinically important difference, the sample size calculations for a repeated measures design using ANCOVA and the VISA-A as primary outcome measure are obtained. Assuming a significance level of alpha= 0.05 (two-sided) and a standard deviation of 20.25, an RCT with a sample size of 16 participants in each treatment group and three follow-up measurements will have a power of greater than 0.8 to detect a minimal clinical important difference of 16 on the VISA-A. Allowing for 20% drop-outs, 20 participants per group (80 participants in total) will be required. This number will also be sufficient to assess the interaction of LLLT and eccentric exercise as power calculations for this interaction with the 2X2 design, moderate effect size (0.5) and alpha set at 0.5 gives a sample size of 17 per group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/07/2013
Actual
19/08/2013
Date of last participant enrolment
Anticipated
14/10/2013
Actual
2/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 5140 0
New Zealand
State/province [1] 5140 0
Otago

Funding & Sponsors
Funding source category [1] 287437 0
University
Name [1] 287437 0
Otago University
Country [1] 287437 0
New Zealand
Primary sponsor type
Individual
Name
Dr Steve Tumilty
Address
Centre for Health, Activity & Rehabilitation Research,
School of Physiotherapy,
University of Otago
325 Great King Street,
Dunedin 9010
Country
New Zealand
Secondary sponsor category [1] 286180 0
None
Name [1] 286180 0
Address [1] 286180 0
Country [1] 286180 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289413 0
Health & Disability Ethics Committee
Ethics committee address [1] 289413 0
Ethics committee country [1] 289413 0
New Zealand
Date submitted for ethics approval [1] 289413 0
19/06/2013
Approval date [1] 289413 0
01/08/2013
Ethics approval number [1] 289413 0
13/NTA/102

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

Contacts
Principal investigator
Name 40678 0
Dr Steve Tumilty
Address 40678 0
Centre for Health, Activity & Rehabilitation Research,
School of Physiotherapy,
University of Otago,
325 Great King Street,
Dunedin 9010
Country 40678 0
New Zealand
Phone 40678 0
+64 (03) 479 7193
Fax 40678 0
Email 40678 0
steve.tumilty@otago.ac.nz
Contact person for public queries
Name 40679 0
Steve Tumilty
Address 40679 0
Centre for Health, Activity & Rehabilitation Research,
School of Physiotherapy,
University of Otago,
325 Great King Street,
Dunedin 9010
Country 40679 0
New Zealand
Phone 40679 0
+64 (03) 479 7193
Fax 40679 0
+64 (03) 479 3979
Email 40679 0
steve.tumilty@otago.ac.nz
Contact person for scientific queries
Name 40680 0
Steve Tumilty
Address 40680 0
Centre for Health, Activity & Rehabilitation Research,
School of Physiotherapy,
University of Otago,
325 Great King Street,
Dunedin 9010
Country 40680 0
New Zealand
Phone 40680 0
+64 (03) 479 7193
Fax 40680 0
+64 (03) 479 3979
Email 40680 0
steve.tumilty@otago.ac.nz

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
SourceTitleYear of PublicationDOI
EmbasePhotobiomodulation and eccentric exercise for Achilles tendinopathy: a randomized controlled trial.2016https://dx.doi.org/10.1007/s10103-015-1840-4
N.B. These documents automatically identified may not have been verified by the study sponsor.