Surgery Versus Continued Conservative Treatment for Neurogenic Thoracic Outlet Syndrome: the First Randomised Clinical Trial (STOPNTOS Trial)

Abstract

Objectives

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).

Design

Randomised controlled clinical trial

Methods

We conducted a single center (high volume, tertiary TOS center), non-blinded, randomized controlled trial with parallel group design. Patients with a diagnosis of NTOS refractory to conservative therapy were randomized into one of two intervention arms and either received a trans-axillary thoracic outlet decompression (TA-TOD) or continued conservative treatment. After 3 months, the conservative treated group was also offered a TA-TOD. Primary outcome was the change in Disability of the Arm, Shoulder and Hand, (DASH) questionnaire score. Secondary outcomes were the change in Cervical-Brachial Symptoms Questionnaire (CBSQ), TOS disability scale and quality of life scores. Outcomes were assessed at baseline, 3, 6 and 12 months after inclusion.

Results

In total, 50 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 3 months, there was a significant difference in DASH scores (TA-TOD: mean: 45.15; confidence interval (CI) [38.08 – 52.21]; conservative treatment: mean 64.92, CI [57.54 -72.30]; p<.001). All patients in the conservative treatment group applied for surgery 3 months after randomization. After surgery of the conservative treatment group, there was no significant difference between the groups for all primary and secondary outcome measures.

Conclusions

TA-TOD for NTOS is effective in patients that do not respond to conservative treatment.

Trial register number

NL63986.100.17