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Trial registered on ANZCTR


Registration number
ACTRN12607000276459
Ethics application status
Approved
Date submitted
4/09/2006
Date registered
22/05/2007
Date last updated
22/05/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Clinical Trial of Prolotherapy Injections and Eccentric Loading Exercises for Painful Achilles Tendinosis
Scientific title
Randomised Clinical Trial of Prolotherapy Injections and Eccentric Loading Exercises for the Treatment of Painful Achilles Tendinosis to Minimise Pain, Stiffness and Disability
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles Tendinosis 1816 0
Condition category
Condition code
Musculoskeletal 1906 1906 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eccentric Loading Exercises - The current 'gold standard' in the treatment of Achilles tendinosis. These exercises are performed twice daily for 12 weeks.
Prolotherapy Injections (30% dextrose/ 0.1% lignocaine/ 0.1% ropivacaine) - Administered weekly beside the tendon for no longer than 12 weeks.
Intervention code [1] 1319 0
Treatment: Other
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2713 0
Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire: Consists of 8 questions measuring the domains of pain, stiffness, function, daily living and sporting activity. On a scale of 0-100, the minimum clinically important difference is 20 and a trivial difference is 10.
Timepoint [1] 2713 0
Measured at baseline, 6 weeks, 3 months, 6 months and 12 months.
Secondary outcome [1] 4577 0
Treatment Satisfaction
Timepoint [1] 4577 0
Measured at baseline, 6 weeks, 3 months, 6 months and 12 months.
Secondary outcome [2] 4578 0
Patient Global Impression of Change
Timepoint [2] 4578 0
Measured at baseline, 6 weeks, 3 months, 6 months and 12 months.
Secondary outcome [3] 4579 0
Sonographic Assessment
Timepoint [3] 4579 0
Measured at baseline, 6 weeks, 3 months, 6 months and 12 months.
Secondary outcome [4] 4580 0
Assessment of Cost-Effectiveness
Timepoint [4] 4580 0
Measured at baseline, 6 weeks, 3 months, 6 months and 12 months.
Secondary outcome [5] 4581 0
Foot Posture Index
Timepoint [5] 4581 0
he Foot Posture Index will only be measured at baseline.

Eligibility
Key inclusion criteria
Clinical diagnosis of painful Achilles tendinosis. Pain and tenderness centred 2-7cm from the calcaneal attachment. Pain longer than 6 weeks. Activity related painVISA-A score less than 80 for participants involved in sport and less than 70 for participants not involved in sport.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous treatment with over 1 month of eccentric loading exercises, any prolotherapy, steroid, polidocinol, aprotinin or autologous blood injectionsAny Achilles surgery or any foot surgery on the affected side in the last yearAllergy to any of the components of the injection solutionAny significant medical condition likely to be fatal or severely disabling in the next 12 monthsInflammatory arthritis or other causes of calf or ankle painCurrent or planned pregnancyAny musculoskeletal condition that prevents them from performing eccentric loading exercises

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)
Allocation invloves contacting the holder of the allocation schedule (NHMRC Clinical Trials Centre who is off-site)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated by the NHMRC Clinical Trials Centre
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The assessor is blinded
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
144
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2052 0
University
Name [1] 2052 0
Griffith University
Country [1] 2052 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 1860 0
None
Name [1] 1860 0
Nil
Address [1] 1860 0
Country [1] 1860 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3808 0
Griffith Univeristy HREC-Logan Hospital
Ethics committee address [1] 3808 0
Ethics committee country [1] 3808 0
Australia
Date submitted for ethics approval [1] 3808 0
Approval date [1] 3808 0
Ethics approval number [1] 3808 0
Ethics committee name [2] 3809 0
Griffith Univeristy HREC-Daisy Hill Surgery
Ethics committee address [2] 3809 0
Ethics committee country [2] 3809 0
Australia
Date submitted for ethics approval [2] 3809 0
Approval date [2] 3809 0
Ethics approval number [2] 3809 0
Ethics committee name [3] 3810 0
Griffith Univeristy HREC-Allsports Physiotherapy (Indooroopilly)
Ethics committee address [3] 3810 0
Ethics committee country [3] 3810 0
Australia
Date submitted for ethics approval [3] 3810 0
Approval date [3] 3810 0
Ethics approval number [3] 3810 0
Ethics committee name [4] 3811 0
Griffith Univeristy HREC- Auchenflower Musculoskeletal Medicine
Ethics committee address [4] 3811 0
Ethics committee country [4] 3811 0
Australia
Date submitted for ethics approval [4] 3811 0
Approval date [4] 3811 0
Ethics approval number [4] 3811 0
Ethics committee name [5] 3812 0
Griffith Univeristy HREC-Buderim Physiotherapy
Ethics committee address [5] 3812 0
Ethics committee country [5] 3812 0
Australia
Date submitted for ethics approval [5] 3812 0
Approval date [5] 3812 0
Ethics approval number [5] 3812 0
Ethics committee name [6] 3813 0
Griffith Univeristy HREC-Caloundra Spinal and Sports Medicine Centre
Ethics committee address [6] 3813 0
Ethics committee country [6] 3813 0
Australia
Date submitted for ethics approval [6] 3813 0
Approval date [6] 3813 0
Ethics approval number [6] 3813 0
Ethics committee name [7] 3814 0
Griffith Univeristy HREC- Musculoskeletal and Golf Injury Clinic (Mosman)
Ethics committee address [7] 3814 0
Ethics committee country [7] 3814 0
Australia
Date submitted for ethics approval [7] 3814 0
Approval date [7] 3814 0
Ethics approval number [7] 3814 0
Ethics committee name [8] 3815 0
Griffith Univeristy HREC-Brighton Spinal Group (Brighton)
Ethics committee address [8] 3815 0
Ethics committee country [8] 3815 0
Australia
Date submitted for ethics approval [8] 3815 0
Approval date [8] 3815 0
Ethics approval number [8] 3815 0

Summary
Brief summary
The reported incidence of painful Achilles tendinosis is 6-17% amongst adult athletes. This condition results in considerable impairment of training and performance in athletes. To date, evidence suggests that of the treatment strategies investigated, exercise programs that involve mildly painful eccentric contractions of the muscles of the calf are the most effective at reducing pain and improving function for people suffering from this condition. Although the underlying mechanism conferring improvement is unknown, there is now some evidence suggesting a link between the presence of newly formed blood vessels (neovascularisation) and painful tendinosis. With a program of mildly painful eccentric loading exercises, there is a sustained reduction in pain with disappearance of these new vessels. Similar sustained reductions in pain have been shown with prolotherapy injections of hypertonic glucose and local anaesthetic. Prolotherapy involves the repeated injections of an irritant solution with the intention of sclerosing neovessels and stimulating inflammation and subsequently new collagen formation. With respect to Achilles tendinosis, the relative efficacy of these two approaches has not been tested. This project aims to conduct a randomised clinical trial comparing prolotherapy injections eccentric loading exercises. It will be conducted in research clinics at Logan, Sydney, Melbourne and Caloundra. Experience and information from the previous pilot trial has been used to inform this adequately powered randomised clinical trial of prolotherapy injections and eccentric loading exercises for painful Achilles tendinosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27926 0
Address 27926 0
Country 27926 0
Phone 27926 0
Fax 27926 0
Email 27926 0
Contact person for public queries
Name 10508 0
Kent Sweeting
Address 10508 0
School of Medicine
Griffith University
Logan Campus
University Drive
Meadowbrook QLD 4131
Australia
Country 10508 0
Australia
Phone 10508 0
+61 7 33821363
Fax 10508 0
+61 7 33821338
Email 10508 0
[email protected]
Contact person for scientific queries
Name 1436 0
Associate Professor Michael Yelland
Address 1436 0
School of Medicine
Griffith University
Logan Campus
University Drive
Meadowbrook QLD 4131
Country 1436 0
Australia
Phone 1436 0
+61 7 33821358
Fax 1436 0
+61 7 33821338
Email 1436 0
[email protected]

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