Our hypothesis is that there is no difference in efficacy between perforation and perforation with application of one of the injection fluids. The potential health care efficiency gain consists of more homogeneity in the treatment of LE. Hereby,…
ID
Bron
Aandoening
lateral epicondylitis, treatment, injectables, RCT.
Ondersteuning
funds are regarded
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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:
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- After provocation test; pain during resisted dorsiflexion of the wrist during full elbow extension
Doel van het onderzoek
Our hypothesis is that there is no difference in efficacy between perforation and perforation with application of one of the injection fluids. The potential health care efficiency gain consists of more homogeneity in the treatment of LE. Hereby, unnecessary treatments can be avoided, a more universal method of treatment can be established and the quality of the treatment can be improved.
Onderzoeksopzet
Assessments will be made before the treatment (baseline), after 8 weeks, 5 months and 1 years after treatment. At the 8 week and 5 months follow-up visit the orthopedic surgeon or trained investigator will perform a physical examination of the elbow and patients will be asked to complete questionnaires at all follow-up moments. After the last follow up moment, the surgeon or investigator will rate any interventions and/or complications
Onderzoeksproduct en/of interventie
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% lidocaine
- Perforation without infiltration all treatments will be performed ultrasound guided and in a standardized and automated way
Publiek
Molengracht 21 <br>
PO box 90158
R. Keijsers
Breda 4818 CK
The Netherlands
reneekeijsers@gmail.com
Wetenschappelijk
Molengracht 21 <br>
PO box 90158
R. Keijsers
Breda 4818 CK
The Netherlands
reneekeijsers@gmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4446 |
| NTR-old | NTR4569 |
| CCMO | NL46385.101.15 |
| OMON | NL-OMON47499 |