None listed
Conditions
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.
Interventions
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
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed