Clinical trial to determine whether the use of blood growth factors in patients with epicondylitis (tennis elbow) at workplace resistant to conservative treatment is better than infiltration with corticoids or the enlargement of the conservative treatment.

Phase III, Single-blinded, placebo-Controlled and randomized Clinical Trial with minimal intervention on the Treatment with Plasma Rich in Growth Factors (PRGF) of Work-site Acute Epicondylitis Resistant to Conservative Treatment - EPILAB

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001249-28-ES

Enrollment

456

Registered

2018-08-02

Start date

2019-05-21

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epicondylitis MedDRA version: 20.0 Level: PT Classification code 10014971 Term: Epicondylitis System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: Celestone Cronodose Pharmaceutical Form: INN or Proposed INN: Corticoides Other descriptive name: BETAMETHASONE ACETATE Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Screening phase a. Men and women older than 18 years b. Patients with new-onset workplace-acquired epicondylitis clinical diagnosis c. First presentation (within 30 days of symptom.-onset), and no previous treatment d. Requiring work-leave 2. Clinical trial phase a. Patients refractory to 7-day treatment with oral antiinflammatory drugs (Dexketoprofeno, Enantyum®, 25 mg 1 TID with meals) 7 days (protocol Annex IV), and to an extended 3-week treatment with standardized physiotherapy (protocol Annex X). b. Patients who provide informed consent to participate in the study (protocol Annex V). c. Patients who reside in the areas where Mutua Universal has a centre with biomechanics and a qualified traumatologist (see protocol section 1.5). 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 456 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients with diabetes or allergies to study treatments. 2. Patients with relapsing epicondylitis . 3. Patients with chronic epicondylitis of more than 30 days. 4. Patients unwilling to sign an informed consent to participate. 5. Patients with severe diseases with life expectancy shorter than 1 year or whose treatment might interfere with that of the EPILAB CCT 6. Patients on antiplatelet or anticoagulant drugs in whom infiltration would be contraindicated. 7. Patients with clinical history of: a. BHV (AgHbs) b. VHC (viral load) c. HIV-I/II d. HTLV I/II 8. Temporarily patients bacterial infection 9. Women of childbearing age, who do not take non-hormonal contraceptive measures.

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary Objective: To determine whether using autologous conditioned platelet-rich plasma with growth factor is more efficacious than betametasone or physiologic serum infiltration in patients refractory o conservative treatment with anti-inflammatory drugs and rehabilitation.;Secondary Objective: Secondary Objective: to establish a standardized rehabilitation protocol to address epicondylitis at workplace in patients refractory to basic initial treatment with anti-inflammatory drugs.; Primary end point(s): Changes from baseline in: 1) Visual Analog Scale of pain to examination procedures (treatment is considered successful when all scores are <2) + 2) DASH (Disabilities of the Arm, Shoulder and Hand) activities inventory score (treatment is considered successful when score < 50 points) + 3) Relapse over one-year (treatment is considered successful when no relapse occurs at 12 months after symptom- onset) ; Timepoint(s) of evaluation of this end point: • Baseline on day 1, 7 and 28 after screening • Reexamination on day 38 days after screening • Reexamination on day 48 days after screening • Reexamination on day 58 days after screening • Reexamination on day 88 days after screening • Reexamination on day 118 days after screening • Contact at12 months after screening to ascertain possible relapse	—

Measure

Time frame

Main Objective: Primary Objective: To determine whether using autologous conditioned platelet-rich plasma with growth factor is more efficacious than betametasone or physiologic serum infiltration in patients refractory o conservative treatment with anti-inflammatory drugs and rehabilitation.;Secondary Objective: Secondary Objective: to establish a standardized rehabilitation protocol to address epicondylitis at workplace in patients refractory to basic initial treatment with anti-inflammatory drugs.; Primary end point(s): Changes from baseline in: 1) Visual Analog Scale of pain to examination procedures (treatment is considered successful when all scores are <2) + 2) DASH (Disabilities of the Arm, Shoulder and Hand) activities inventory score (treatment is considered successful when score < 50 points) + 3) Relapse over one-year (treatment is considered successful when no relapse occurs at 12 months after symptom- onset) ; Timepoint(s) of evaluation of this end point: • Baseline on day 1, 7 and 28 after screening • Reexamination on day 38 days after screening • Reexamination on day 48 days after screening • Reexamination on day 58 days after screening • Reexamination on day 88 days after screening • Reexamination on day 118 days after screening • Contact at12 months after screening to ascertain possible relapse

—

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: Does not apply	—

Countries

Spain

Contacts

Public ContactJaume Marrugat

IMIM Hospital del Mar

jmarrugat@imim.es34933160773

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026