Surgical Thoracic Outlet Decompression for Neurogenic Thoracic Outlet Syndrome (STOPNTOS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03748602|
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neurogenic Thoracic Outlet Syndrome||Procedure: Thoracic outlet decompression||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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)|
|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|
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
- 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).
- 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.
- 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.
- 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
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
|Contact: Jens Goeteyn, MDemail@example.com|
|Contact: Joep Teijink, MD, PhD||003140 firstname.lastname@example.org|
|Principal Investigator:||Joep Teijink, MD, PhD||Vascular surgeon - Catharina Ziekenhuis Eindhoven|