Objective
Neurogenic thoracic outlet syndrome (NTOS) is one of the most controversial clinical
entities in medicine. Several major case series have shown promising results of surgery;
however, solid scientific evidence is lacking. The aim of this trial was to objectify
the effect of thoracic outlet decompression (TOD).
Methods
A single centre (high volume, tertiary TOS centre), non-blinded, randomised controlled
trial was conducted with parallel group design. Patients with a diagnosis of NTOS
refractory to conservative therapy were randomised to one of two intervention arms,
receiving either a transaxillary thoracic outlet decompression (TA-TOD) or continued
conservative treatment. After three months, the conservative treated group was also
offered a TA-TOD. The primary outcome was change in Disability of the Arm, Shoulder
and Hand (DASH) questionnaire score. Secondary outcomes were changes in Cervical Brachial
Symptoms Questionnaire (CBSQ), TOS disability scale, and quality of life scores. Outcomes
were assessed at baseline, three, six, and 12 months after inclusion.
Results
Fifty patients were enrolled in this trial: 25 in the TA-TOD group and 25 in the continued
conservative treatment group. Follow up was completed in 24 and 22 patients, respectively.
At three months, there was a statistically significant difference in DASH scores (TA-TOD:
mean 45.15, 95% confidence interval [CI] 38.08 – 52.21; conservative treatment: mean
64.92, 95% CI 57.54 – 72.30; p < .001). All patients in the conservative treatment group applied for surgery three
months after randomisation. After surgery of the conservative treatment group, there
was no statistically significant difference between the groups for all primary and
secondary outcome measures.
Conclusions
TA-TOD for NTOS is effective in patients who do not respond to conservative treatment.
Trial register number: NL63986.100.17.
Keywords
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Article info
Publication history
Published online: May 07, 2022
Accepted:
May 1,
2022
Received:
September 5,
2021
Footnotes
☆This research was communicated during the 35th European Society for Vascular Surgery (ESVS) hybrid annual meeting in Rotterdam in 2021.
Identification
Copyright
© 2022 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.
