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Surgical Thoracic Outlet Decompression for Neurogenic Thoracic Outlet Syndrome (STOPNTOS)

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ClinicalTrials.gov Identifier: NCT03748602
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Joep Teijink, Catharina Ziekenhuis Eindhoven

Brief 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).

Condition or disease Intervention/treatment Phase
Neurogenic Thoracic Outlet Syndrome Procedure: Thoracic outlet decompression Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Thoracic Outlet Decompression Versus Conservative Approach for Patients With Neurogenic Thoracic Outlet Syndrome, a Randomized Controlled Trial
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2024


Arm Intervention/treatment
Experimental: TOD
Thoracic Outlet Decompression (TOD)
Procedure: Thoracic outlet decompression
TOD consists out of first rib resection with partial scalenectomy and neurolysis. If there are also complaints below the pectoral minor tendon insertion, a pectoral minor tenotomy is performed.

No Intervention: Conservative therapy
Physiotherapy and pain relief



Primary Outcome Measures :
  1. Change in Disability of the Arm, Shoulder and Hand (DASH) score [ Time Frame: Change in this outcome will be measured at 0, 3, 6, 12, 24, 36 and 60 months after inclusion ]
    This questionnaire is validated for neurogenic thoracic outlet syndrome and was developed by the American Academy of Traumatology. It includes 30 questions related to symptoms of daily activities and social and psychological functions. Scores range from asymptomatic (0) to totally invalid (100).


Secondary Outcome Measures :
  1. Chance in Cervical-Brachial Symptoms (CBSQ) Questionnaire score [ Time Frame: Change in this outcome will be measured at 0, 3, 6, 12, 24, 36 and 60 months after inclusion ]
    This questionnaire is validated for neurogenic thoracic outlet syndrome and consist out of 12 questions with the answer going from 0 to 10, 2 questions Y/N answers, 1 question with a visual feedback which parts of the neck, shoulder, arm or hand have most symptoms.

  2. Change in Visual Analogue Scale (VAS) for Pain [ Time Frame: Change in this outcome will be measured at 0, 3, 6, 12, 24, 36 and 60 months after inclusion ]
    This scale measures pain going from 0 (none) to 10 (intens) Patients can chose any number between 0 and 10 to accuratly rate their pain.

  3. Change in Short Form 12 (SF-12) questionnaire score [ Time Frame: Change in this outcome will be measured at 0, 3, 6, 12, 24, 36 and 60 months after inclusion ]
    This questionnaire measures quality of life. It consist out of 12 questions with answers going from Y/N to 0 to 5



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • High suspicion of NTOS with high level of impairment.

    • The decision to refer a patient with NTOS for surgery is placed at the sole authority of the TOS multidisciplinary workgroup. Members of this workgroup are 2 dedicated vascular surgeons, 2 neurologists, 1 orthopedic surgeon, 3 physiotherapists, 2 radiologists, 3 anesthesiologists.
    • This decision is based on the reporting standards published by Illig et al. in 2016. If a patient fits the criteria postulated in the reporting standards and if there is consensus within the multidisciplinary team, only then patients are referred for TOD.
  • Fit for surgery, at the discretion of the treating vascular surgeon and anesthesiologist.
  • Signed informed consent form.
  • 18 years of age or older
  • Dutch or English speaking patients

Exclusion Criteria:

  • Unfit for surgery, at the discretion of the treating vascular surgeon and anesthesiologist.
  • Younger than 18 years of age
  • Patients that do not speak Dutch or English.
  • Patients with a history of TOD
  • Patients that did not receive previous conservative physiotherapy for this condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748602


Contacts
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Contact: Jens Goeteyn, MD 0032475441137 jens.goeteyn@catharinaziekenhuis.nl
Contact: Joep Teijink, MD, PhD 003140 2397150 joep.teijink@catharinaziekenhuis.nl

Locations
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Netherlands
Catharina Ziekenhuis Recruiting
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
Contact: Jens Goeteyn, MD    0032475441137    jens.goeteyn@catharinaziekenhuis.nl   
Contact: Joep Teijink, MD, PhD       joep.teijink@catharinaziekenhuis.nl   
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Investigators
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Principal Investigator: Joep Teijink, MD, PhD Vascular surgeon - Catharina Ziekenhuis Eindhoven

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Responsible Party: Joep Teijink, Professor in vascular surgery, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT03748602     History of Changes
Other Study ID Numbers: NL63986.100.17
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joep Teijink, Catharina Ziekenhuis Eindhoven:
thoracic outlet decompression (TOD)
Additional relevant MeSH terms:
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Thoracic Outlet Syndrome
Aneurysm, Dissecting
Syndrome
Disease
Pathologic Processes
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Nerve Compression Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases