lateral epicondylitis, treatment, injectables, RCT.
Conditions
Interventions
The following treatments are investigated:
- Perforation with infiltration of 0.4cc autologous blood
blood is taken by venipuncture and directly injected in the affected tendon
- Perforation with infiltration of 0.4cc dextrose: solution with 4ml of 50% dextrose+ 4ml of 90% saline + 2ml of 1% lidocai
Sponsors
Amphia hospital Breda. OLVG Amsterdam. AMC Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: Patients referred by their GP to the orthopaedic surgeon diagnosed with unilateral Lateral Epicondylitis lasting longer than 6 weeks • Age between 18 and 65 years • Unsuccessful conservative treatment • Able to read and write in Dutch • Provision of informed consent by patient. Pain reduction seems dependent on physical factors like high physical job demands. To secure similar group sizes and comparable work-related characteristics at each point in time, block randomization will be used
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Prior injection therapy (during this episode of LE), surgery or trauma at the affected elbow. • Inflammatory diseases (i.e. rheumatoid arthritis, psoriatic arthritis, or reactive arthritis). • Patients with any other elbow pathology. • Neck pain or shoulder pain correlated with elbow pain such as C6 radiculopathy or with disability of the arm or other chronic widespread pain syndromes. • Traumatic onset of LE. • Bilateral LE (mild cases of LE on the contralateral elbow without functional limitations are allowed). • Abnormalities on the X-ray. • Patients with additional pain at the medial epicondyl. • Allergy for lidocaine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are the changes in pain using a Visual Analog Scale (VAS, 0-100) (Bodian e.a. 2001) 5 months after treatment: - After provocation test; pain during resisted dorsiflexion of the wrist during full elbow extension | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are the changes in pain using a Visual Analog Scale (VAS, 0-100) compared to baseline 5 months after treatment and after 8 weeks and 1 year after treatment (at rest and after maximun grip strength), functional recovery, Quality adjusted life years and complications | — |
Contacts
Public ContactR. Keijsers
Amphia Ziekenhuis Breda Molengracht 21 PO box 90158
Outcome results
None listed