Chronic Tendinopathy: The Biomechanical Associations and EfFicacy of Injectable Therapy (BE FIT) Study

Phase 1

Conditions: Chronic degenerative Achilles and patella tendinopathy patients, with neovascularisation on USS, who have failed best practice rehabilitation including Eccentric Loading (EL), Heavy Slow Resistance Training (HSR) and Extra-Corporal Shock Wave Therapy (ESWT) will be randomised to one of three injections: 3ml of Marcain Polyamp 0.5% (Placebo) or 10 ml of Marcain Polyamp 0.5%+2.5ml Sodium Chloride 0.9% or 10ml of Marcain Polyamp 0.5%+2.25ml Sodium Chloride 0.9% + 0.25ml Efcortesol 100mg/ml.
MedDRA version: 18.1Level: LLTClassification code 10000433Term: Achilles tendinitisSystem Organ Class: 100000004859
MedDRA version: 18.1Level: LLTClassification code 10034123Term: Patellar tendinitisSystem Organ Class: 100000004859
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2015-003587-36-GB

Lead Sponsor: Directorate of Defence Rehabilitation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 108

Inclusion Criteria

Chronic Achilles and patella tendinopathy patients
Age 18-55
Male
No or minimal improvement with physical rehabilitation pathway outlined below
Minimum duration of symptoms of 6 months
US evidence of neovascularization
Patients must be medically downgraded and not deployable

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Concurrent alternate lower limb diagnosis
Female
Anticoagulant medication
Previous tendon surgery or injection