|- candidate number||16887|
|- NTR Number||NTR4569|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-mrt-2014|
|- Secondary IDs||NL46385.101.15 MEC TWOR, Rotterdam, the Netherlands|
|- Public Title||Standardized needle therapy in LE|
|- Scientific Title||Effectiveness of Ultrasound Guided Percutaneous treatment of Lateral Epicondylitis using standardized perforation with application of autologous blood, dextrose or perforation only, in relation to pain and functional recovery; A randomized controlled trial
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Lateral Epicondylitis , Treatment|
|- 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||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
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2015|
|- planned closingdate||1-mrt-2019|
|- Target number of participants||165|
|- 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% lidocaine
- Perforation without infiltration all treatments will be performed ultrasound guided and in a standardized and automated way
|- Primary outcome||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 outcome||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
|- Timepoints||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
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MD R. Keijsers|
|- CONTACT for SCIENTIFIC QUERIES||MD R. Keijsers|
|- Sponsor/Initiator ||Amphia Hospital Breda, Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||17-mrt-2014 - 7-sep-2018|