The epicondylitis is an overuse injury, in most cases, is a self-limited course and responds well to conservative treatment. Its etiology is degenerative and is related to a repetitive overuse and underlying tendinopathy.
Conditions
Interventions
Product Name: platelet rich plasma
Product Code: platelet rich plasma
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: platelet rich plasma
Other descriptive name
Sponsors
Ibermutuamur (Mutua Colaboradora con la Seguridad Social nº 274)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Workers diagnosed with work-related epicondylitis (ICD 9-CM code 726.32) as the primary diagnosis, receiving healthcare in Ibermutuamur. - Age equal or greater than 18 years. - Patients receive this diagnosis after being explored: painful sensitivity to pressure on the epicondyle; Cozen maneuver; chair test; and radiological examination. - Does not present remission of symptoms after a period of approximately 25 days of conservative treatment that include oral medication, local cold, functional relative rest and rehabilitation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 66 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with cervical pathology. - With posterior interosseous neuropathy. - With any kind (unless cancer pathology hospital discharge) cancer. - Patients with mental health problems that prevent them from successfully follow rehabilitation treatment. - Patients with thrombocytopenia. - Patients who have pacemakers. - Clotting problems or anticoagulant therapy. - Rheumatoid arthritis diagnosed. - Pregnant or breast-feeding patients. - Treatment with deposit costicoesteroid infiltrations in the last 6 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): - Pain visual analog scale (VAS). - DASH (Disability of the Arm, Shoulder & Hand) score. - Variables biomechanical study - Ultrasound;Timepoint(s) of evaluation of this end point: Baseline: VAS and DASH scales (conventional therapy). 10 days: VAS, DASH, biomechanical assessment. 1 month: VAS, DASH, biomechanical assessment and ultrasound after physical rehabilitation if needed (recruitment and study group intervention assignment). 1 month: VAS and DASH. 2 months: biomechanical assessment and ultrasound. 3 months: VAS, DASH, biomechanical assessment and ultrasound.;Main Objective: To compare the efficacy of extracorporeal shockwave, infiltrations of autologous platelet-rich plasma and combination therapy with both, in patients with work-related epicondylitis, which do not respond to initial treatment with anti-inflammatory drugs and rehabilitation (level of pain, functional recovery, mobility, temporary disability and percentage of workers who require surgery).;Secondary Objective: To assess the cost-effectiveness of the three treatment care protocol modalities in controlling the work-related sick-leave period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Demographic variables. - Employer company and job variables. - Clinical variables.;Timepoint(s) of evaluation of this end point: - Demographic variables: baseline. - Employer company and job: baseline. - Clinical variables: baseline and one year after the recruitment (end of the study). | — |
Countries
Spain
Contacts
Public ContactDepartamento Proyectos Sanitarios
Ibermutuamur (Mutua Colaboradora con la Seguridad Social nº 274)
Outcome results
None listed