Leukocyte and Platelet Rich Plasma Versus Type A Botulinum Toxin Versus Glucocorticoids for the Treatment of Lateral Epicondylalgia: a Randomized, Multicenter, Double-blind, Therapeutic Trial With Three Parallel Arms
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Visual analog scale (VAS) for pain over the last 24 hours
Overview
Brief Summary
The primary objective of this study is to compare the evolution of pain profiles among patients suffering from lateral epicondyalgia (tennis elbow) following three types of treatment: PRP-L injection versus type A botulinum toxin injection versus corticoid injection.
Detailed Description
The secondary objectives are to compare the following among the three groups:
A- The global efficacy of each treatment defined by a minimum reduction of 25% in average pain over the last 24 hours between 0 and 6 months.
B- The evolution of average pain over the last 24 hours between 0 and each different time frame (3 weeks, 6 weeks, 3 months and 6 months).
C- The evolution of maximum pain scores using nocturnal post-effort (Jamar grip test) visual analog scales (VAS) between day 0, 3 weeks, 6 weeks, 3 months and 6 months.
D- The perception of change on the Patient's Global Impression of Change score (PGIC) at 3 and 6 months E- The evolution of PRTEE scores at 0, 3 and 6 months F- Adverse events at 3 weeks, 6 weeks, 3 months and 6 months. G - Quality of life and utility via the SF-12 at 3 and 6 months. H- The consumption of analgesics.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
PRP-L Group
Patients randomized to this group will be treated with an injection of Leukocyte and Platelet Rich Plasma (PRP-L).
Intervention: PRP-L Injection
Intervention: PRP-L Injection (Drug)
Botox Group
Patients randomized to this group will be treated with an injection of Type A Botulinum Toxin (Xeomin®, MERZ).
Intervention: Botox injection
Intervention: Botox injection (Drug)
Corticoid Group
Patients randomized to this group will be treated with an injection of Corticoids.
Intervention: Corticoid injection
Intervention: Corticoid injection (Drug)
Outcomes
Primary Outcomes
Visual analog scale (VAS) for pain over the last 24 hours
Time Frame: 6 months versus Baseline (day 0)
score varying from 0 to 10
Secondary Outcomes
- Visual analog scale for pain over the last 24 hours(3 months)