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 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.
Interventions
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.
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 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.
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
Outcome results
None listed