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Trial registered on ANZCTR


Registration number
ACTRN12606000179538
Ethics application status
Approved
Date submitted
8/05/2006
Date registered
16/05/2006
Date last updated
16/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot Randomised Clinical Trial of Prolotherapy Injections and Eccentric Loading Exercises Singly and in Combination for the Treatment of Painful Achilles Tendinosis
Scientific title
Pilot Randomised Clinical Trial of Prolotherapy Injections and Eccentric Loading Exercises Singly and in Combination 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 1152 0
Condition category
Condition code
Musculoskeletal 1233 1233 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prolotherapy Injections (20% dextrose/ 0.1% lignocaine/ 0.1% ropivacaine) - Administered weekly for no longer than 12 weeks.
Eccentric Loading Exercises - The current 'gold standard' in the treatment for Achilles tendinosis. These exercises are performed twice daily by the participant at home. The exercises are performed twice daily for 12 weeks.
Combined Prolotherapy Injections and Eccentric Loading Exercises
Intervention code [1] 1026 0
Treatment: Other
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1671 0
Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire: Consists of eight questions measuring the domains of pain, stiffness, function in 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] 1671 0
Measured at baseline, six weeks, three months and six months.
Secondary outcome [1] 2991 0
Treatment Satisfaction
Timepoint [1] 2991 0
Meausred at baseline, six weeks, three months and six months.
Secondary outcome [2] 2992 0
Patient Global Impression of Change
Timepoint [2] 2992 0
Meausred at baseline, six weeks, three months and six months.
Secondary outcome [3] 2993 0
Sonographic Assessment
Timepoint [3] 2993 0
Meausred at baseline, six weeks, three months and six months.
Secondary outcome [4] 2994 0
Assessment of Cost-Effectiveness
Timepoint [4] 2994 0
Meausred at baseline, six weeks, three months and six months.

Eligibility
Key inclusion criteria
Clinical diagnosis of painful Achilles tendinosisPain and tenderness centred 2-7 cm from the calcaneal attachmentPain longer than 3 months. Activity related pain VISA-A score less than 80 for participants involved in sport and less than 70 for people not involved in sport.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous treatment with over one month of eccentric loading exercises, any prolotherapy injections, any Achilles surgery or any foot surgery on the affected side in the last year.Bilateral symptomsAllergy to any of the components of the injection solutionSignificant medical conditions likely to be fatal or severely disabling in the next 3 monthsInflammatory arthritis or other causes of calf or ankle painDiabetes mellitusCurrent or planned pregnancyA steroid injection in or near the affected Achilles tendon in the last 3 monthsAny musculoskeletal condition that 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 involves 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
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1348 0
University
Name [1] 1348 0
Griffith University
Address [1] 1348 0
Country [1] 1348 0
Australia
Funding source category [2] 1349 0
Charities/Societies/Foundations
Name [2] 1349 0
Musculoskeletal Research Foundation of Australia
Address [2] 1349 0
Country [2] 1349 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 1192 0
None
Name [1] 1192 0
Nil
Address [1] 1192 0
Country [1] 1192 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2700 0
Logan Hospital
Ethics committee address [1] 2700 0
Ethics committee country [1] 2700 0
Australia
Date submitted for ethics approval [1] 2700 0
Approval date [1] 2700 0
17/02/2006
Ethics approval number [1] 2700 0
MED/04/06/HREC
Ethics committee name [2] 2701 0
Active Health, QEII Stadium, Christchurch
Ethics committee address [2] 2701 0
Ethics committee country [2] 2701 0
New Zealand
Date submitted for ethics approval [2] 2701 0
Approval date [2] 2701 0
17/02/2006
Ethics approval number [2] 2701 0
MED/04/06/HREC

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, individually and in combination, has not been tested. This project aims to conduct a pilot randomised clinical trial comparing prolotherapy injections eccentric loading exercises singly and in combination. It will be conducted in research clinics to be set up at Logan and in Christchurch, New Zealand. It will be a single blinded trial with the assessor being the blinded person. Experience and information from this pilot trial will be used to inform an 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 36364 0
Address 36364 0
Country 36364 0
Phone 36364 0
Fax 36364 0
Email 36364 0
Contact person for public queries
Name 10215 0
Associate Professor Michael Yelland
Address 10215 0
School of Medicine
Griffith University
Logan Campus
University Drive
Meadowbrook QLD 4131
Country 10215 0
Australia
Phone 10215 0
+61 7 33821358
Fax 10215 0
+61 7 33821338
Email 10215 0
m.yelland@griffith.edu.au
Contact person for scientific queries
Name 1143 0
Kent Sweeting
Address 1143 0
School of Medicine
Griffith University
Logan Campus
University Drive
Meadowbrook QLD 4131
Country 1143 0
Australia
Phone 1143 0
+61 7 33821363
Fax 1143 0
+61 7 33821338
Email 1143 0
k.sweeting@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
No Results