Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03748602 |
| Other study ID # |
NL63986.100.17 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2018 |
| Est. completion date |
October 1, 2024 |
Study information
| Verified date |
July 2022 |
| Source |
Catharina Ziekenhuis Eindhoven |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will determine the value of TOD (first rib resection with partial scalenectomy and
neurolysis) on functionality and quality of life for patients with neurogenic thoracic outlet
syndrome. This will be done by randomizing patients into surgery or conservative therapy
(physiotherapy and pain relief).
Description:
Background:
Neurogenic thoracic outlet syndrome (NTOS) is a condition caused by compression and
irritation of the brachial plexus serving the upper extremity. NTOS most frequently occurs in
relatively young, active and otherwise healthy individuals and can have a tremendous impact
on work, social and personal life. The diagnosis and therapy of NTOS still remains disputed.
This is partly because diagnosis is largely clinical and subjective in nature, with no
definitive (diagnostic) imaging or diagnostic studies available. As a result, disparities in
the definition have produced different opinions regarding diagnostic standards for TOS.
Furthermore, given the controversy surrounding the definition and diagnosis of TOS, conflict
exists regarding the optimal treatment approach for this condition.
Studies in the last years, have shed light on some of the controversies in diagnosing and
treating NTOS. Many patients that benefit from thoracic outlet decompression (TOD) do not fit
the historical diagnostic criteria. Those patients (up to 90%) with disputed NTOS have shown
improvement of symptoms and functionality after TOD surgery.
Recently, several studies have been published about outcome after TOD surgery for NTOS. These
large, multicenter studies show a very low complication rate, ranging from 0-2%, with an
extremely low risk of nerve injury.
These studies however report on heterogenous populations, diagnosed without any
internationally validated diagnostic criteria. They hint beneficial results for TOD in NTOS
patients, however the level of evidence they provide is low. Critics have wondered if the
improvements - reported in these trials - are attributed to surgery, or are merely due to
coincidence, selection bias, conservative treatment or time (rest).
The society of vascular surgery published reporting standards in 2016 to produce consistency
in diagnosis, description of treatment and assessment of results to allow more valuable data
to be reported. The investigators believe that a randomized controlled trial - using the
reporting standards- could demonstrate the actual added value of a TOD (first rib resection
with partial scalenectomy and neurolysis).
Objective:
The objective of this study is to determine the value of TOD (first rib resection with
partial scalenectomy and neurolysis) on functionality and quality of life. This will be done
by randomizing patients who already received conservative physiotherapy into surgery or
continued conservative therapy (physiotherapy and pain relief). After 3 months, the patients
with continued maximum conservative therapy will be offered surgery as well if complaints
persist. The effect of TOD will be examined by following the change in functionality and
quality of life compared to conservative physiotherapy. The durability of these effects on
functional assessment and quality of life will also be examined by following patients for 5
years.
Study design:
Single center randomized controlled trial
Study population:
All patients diagnosed with NTOS refractory to conservative physiotherapy treatment (based on
criteria produced by the reporting standards) and considered to benefit from TOD in a
multidisciplinary TOS-consensus group are considered candidates for this study.
Intervention:
Patients will be randomized into surgery (TOD) versus conservative physiotherapy. The group
randomised for conservative physiotherapy will be offered surgical therapy after 3 months if
complaints persist.
Main study parameters/endpoints:
Primary endpoint is DASH SCORE. This endpoint will be measured with the DASH questionnaire
(Disability of the Arm, Shoulder and Hand) Secondary endpoints will be the score on the CBSQ,
VAS scale and SF 12. These endpoints will be measured with the CBSQ questionnaire
(Cervical-Brachial Symptoms Questionnaire), VAS scale (Visual Analogue Scale for Pain) and SF
12 (Short Form 12 questionnaire)
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness:
All patients are operated with the same technique and by the same operator. There is a delay
of 3 months for half of the subjects (control group), which is relative due to the early
operation (in comparison with the existing waiting list for regular TOD of around 3 months)
of the group that is randomised for TOD. There is no denial of 'optimal medical treatment'
for any of the participating subjects.
