Surgical Thoracic Outlet decompression versus conservative approach for Patients with Neurogenic Thoracic Outlet Syndrome, a randomized controlled trial (STOPNTOS)

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.[1, 2] 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 [3, 4] Those
patients (up to 90%) with disputed NTOS have shown improvement of symptoms and
functionality after TOD surgery. [5-8]
Recently, several studies have been published about outcome after TOD surgery
for NTOS. These large, multicentre studies clearly show a very low complication
rate ranging from 0-2%, with an extremely low risk of nerve injury. [5, 9-13]


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.[7] We 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).

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. We will do this by randomizing patients into who already
received physiotherapy into TOD or continued conservative physiotherapy. If
patients in the conservative group still have complaints after 3 months, TOD
will be offered and performed as well.
First, we will examine the effect of TOD versus physiotherapy on functionality
and quality of life. We will look if there is a relation between the moment
TOD and a change in functionality and quality of life. We will also determine
the durability of the effect of TOD on functional assessment and quality of
life (follow-up period of 5 years).

Single center randomized controlled trial

Patients with a diagnosis of NTOS will be randomized into TOD versus
conservative treatment. The group with conservative treatmentwill receive
surgical therapy after 3 months if complaints persist.

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 (except those patients
who experienced such amount of relieve of their complaints under continuing
physical therapy - these patients will not be operated of course), which is
relative due to the early operation (in comparison with the existing waiting
list) of the group that is randomised for direct TOD. There is no denial of
*optimal medical treatment* for any of the participating subjects.