TY - JOUR
T1 - Surgery versus continued conservative treatment for neurogenic thoracic outlet syndrome
T2 - the first randomised clinical trial (STOPNTOS-trial)
AU - Goeteyn, Jens
AU - Pesser, Niels
AU - Houterman, S
AU - van Sambeek, Marc R H M
AU - van Nuenen, Bart F L
AU - Teijink, Joep A W
N1 - Copyright © 2022 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.
PY - 2022/7
Y1 - 2022/7
N2 - 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.
AB - 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.
U2 - 10.1016/j.ejvs.2022.05.003
DO - 10.1016/j.ejvs.2022.05.003
M3 - Article
C2 - 35537641
SN - 1078-5884
VL - 64
SP - 119
EP - 127
JO - European Journal of Vascular and Endovascular Surgery
JF - European Journal of Vascular and Endovascular Surgery
IS - 1
ER -