Randomised Clinical Trial of Prolotherapy Injections and Eccentric Loading Exercises for Painful Achilles Tendinosis

Phase 3

• Conditions: Achilles Tendinosis; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12607000276459
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[Measured at baseline, 6 weeks, 3 months, 6 months and 12 months.]

Secondary Outcome Measures

Name	Time	Method
Treatment Satisfaction[Measured at baseline, 6 weeks, 3 months, 6 months and 12 months.];Patient Global Impression of Change[Measured at baseline, 6 weeks, 3 months, 6 months and 12 months.];Sonographic Assessment[Measured at baseline, 6 weeks, 3 months, 6 months and 12 months.];Assessment of Cost-Effectiveness[Measured at baseline, 6 weeks, 3 months, 6 months and 12 months.];Foot Posture Index[he Foot Posture Index will only be measured at baseline.]