RecruitingPhase 2Phase 3ACTRN12606000179538

Pilot Randomised Clinical Trial of Prolotherapy Injections and Eccentric Loading Exercises Singly and in Combination for the Treatment of Painful Achilles Tendinosis

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.


Sponsor

Griffith University

Enrollment

24 participants

Start Date

May 15, 2006

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing two treatments for painful Achilles tendinosis — a condition where the thick tendon at the back of your heel becomes painful and damaged, often in active people or athletes. The two treatments are: (1) a program of slightly painful calf exercises (eccentric loading), and (2) prolotherapy injections — injections of a glucose solution meant to stimulate healing. The study will also test whether combining both treatments works best. You may be eligible if: - You are 18 years or older - You have been diagnosed with painful Achilles tendinosis - Your pain and tenderness is centred 2–7 cm above the heel bone - Your pain has lasted more than 3 months - Your pain is activity-related You may NOT be eligible if: - You have already done more than one month of eccentric loading exercises for this condition - You have previously had prolotherapy injections - You have had surgery on the affected Achilles tendon or foot in the last year - You have pain on both sides - You are allergic to any component of the injection - You have a serious or life-threatening illness expected within 3 months - You have inflammatory arthritis or other causes of ankle or calf pain - You have diabetes - You are pregnant or planning to become pregnant - You had a steroid injection near the affected tendon in the last 3 months - You have a condition preventing you from doing eccentric exercises Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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


Locations(1)

Australia

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ACTRN12606000179538