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
Conditions
Interventions
Trade Name: Marcain Polyamp Steripack 0.5%
Product Name: Marcain Polyamp Steripack 0.5%
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Bupivacaine Hydrocholride
Concentration unit: %
Sponsors
Directorate of Defence Rehabilitation
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria: Concurrent alternate lower limb diagnosis Female Anticoagulant medication Previous tendon surgery or injection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Hypothesis 1 High Volume Effect in both the presence and absence of steroid is superior to placebo. Implications The literature contains many papers by the same group indicating that the proposed successes may be operator dependent. If we can demonstrate the High Volume Effect to work independently with a simpler technique then Defence Rehabilitation will benefit in a way that is not currently applicable from the literature. Frequently innovative sports medicine procedures have become commonplace without sufficient evidence and at high risk of bias53. The lack of control groups in trials relating to the High Volume Effect desperately needs to be addressed. ;Secondary Objective: Hypothesis 2 HVE without CS is non-inferior to HVE with CS. Implications Separating the effect of HVE and CS, two very different mechanisms of action, is vital to further injectable therapy in tendinopathy. By conducting this trial Defence Rehabilitation will provide further evidence for its own pathway and will also be making a significant contribution to the scientific literature. Hypothesis 3 Specific biomechanical factors will be associated with patella tendinopathy in symptomatic patients during walking and one leg squat assessments. Implications The number of participants will also be comparable to previous trials allowing us to build on those findings. Use of our patients in this trial will allow us to confirm if these associations are relevant to the defence population as much of the current data is extrapolated from very specifically trained athletes. Confirmed strategies can then be emphasised throughout Defence. Education of personnel at an early stag;Primary end point(s): Primary outcomes will be: a. The Visual Analogue Scale (VAS) for pain. This is a subjective score from the participant on pain level recorded by asking the patient to mark along a 100mm line their pain level with 0mm representing no pain and 100mm maximal pain. b. Validated Vict | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes will be: a. The degree of neovascularisation measured using the modified Ohberg Score2. This will be recoded as follows: 0= No vessels visible 1= 1 vessel mostly anterior to the tendon 2= 1 or 2 vessels throughout the tendon 3= 3 vessels throughout the tendon 4= More than three vessels throughout the tendon Images will be stored to disk and kept in a locked cabinet within the DMRC Academic Department of Military Rehabilitation. Scoring will be made by one of the two operators delivering injections either Col A Nicol or Dr I McCurdie who will be blinded to type of injectate as described above. b. The Functional Activity Assessment (FAA) score which is validated in the military population3. The score being: FAA 1= Fully Fit FAA 2= Fit for trade and fit for restricted general or military duties FAA 3= Unfit for trade but fit for restricted general or military duties FAA 4= Unfit for all but sedentary duties FAA 5= Off all duties This is self-reported by the participant. There will biomechanical evaluation (using kinetics and kinematics) of a patella tendinopathy subgroup nested within the trial at baseline and 6 months follow up only. ;Timepoint(s) of evaluation of this end point: Baseline, 6 weeks, 3months and 6 months. There will be biomechanical evaluation (using kinetics and kinematics) of a patella tendinopathy subgroup nested within the trial at baseline and 6 months follow up only. This will be compared with a group of healthy controls. There will be a correlational study multiple regression analysis of epidemiological factors that will be used to look for predictors between tendinopathy participants and matched controls. | — |
Countries
United Kingdom
Contacts
Public ContactBarker-Davies
Defence Medical Rehabilitation Centre Headley Court
Outcome results
None listed