Neurogenic Thoracic Outlet SyndromeSTOPNTOSNCT03748602
Surgical Thoracic Outlet Decompression for Neurogenic Thoracic Outlet Syndrome
A study testing Thoracic outlet decompression in people with Neurogenic Thoracic Outlet Syndrome, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurogenic Thoracic Outlet Syndrome
- What is being tested?
- Thoracic outlet decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2018to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Thoracic Outlet Decompression Versus Conservative Approach for Patients With Neurogenic Thoracic Outlet Syndrome, a Randomized Controlled Trial
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).
Read the detailed description
Background:
Neurogenic thoracic outlet syndrome (NTOS) is a condition caused by compression and irritation of the brachial plexus serving the upper extremity. NTOS most frequently occurs in relatively young, active and otherwise healthy individuals and can have a tremendous impact on work, social and personal life. The diagnosis and therapy of NTOS still remains disputed. This is partly because diagnosis is largely clinical and subjective in nature, with no definitive (diagnostic) imaging or diagnostic studies available. As a result, disparities in the definition have produced different opinions regarding diagnostic standards for TOS. Furthermore, given the controversy surrounding the definition and diagnosis of TOS, conflict exists regarding the optimal treatment approach for this condition.
Studies in the last years, have shed light on some of the controversies in diagnosing and treating NTOS. Many patients that benefit from thoracic outlet decompression (TOD) do not fit the historical diagnostic criteria. Those patients (up to 90%) with disputed NTOS have shown improvement of symptoms and functionality after TOD surgery.
Recently, several studies have been published about outcome after TOD surgery for NTOS. These large, multicenter studies show a very low complication rate, ranging from 0-2%, with an extremely low risk of nerve injury.
These studies however report on heterogenous populations, diagnosed without any internationally validated diagnostic criteria. They hint beneficial results for TOD in NTOS patients, however the level of evidence they provide is low. Critics have wondered if the improvements - reported in these trials - are attributed to surgery, or are merely due to coincidence, selection bias, conservative treatment or time (rest).
The society of vascular surgery published reporting standards in 2016 to produce consistency in diagnosis, description of treatment and assessment of results to allow more valuable data to be reported. The investigators believe that a randomized controlled trial - using the reporting standards- could demonstrate the actual added value of a TOD (first rib resection with partial scalenectomy and neurolysis).
Objective:
The objective of this study is to determine the value of TOD (first rib resection with partial scalenectomy and neurolysis) on functionality and quality of life. This will be done by randomizing patients who already received conservative physiotherapy into surgery or continued conservative therapy (physiotherapy and pain relief). After 3 months, the patients with continued maximum conservative therapy will be offered surgery as well if complaints persist. The effect of TOD will be examined by following the change in functionality and quality of life compared to conservative physiotherapy. The durability of these effects on functional assessment and quality of life will also be examined by following patients for 5 years.
Study design:
Single center randomized controlled trial
Study population:
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.
Intervention:
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.
Main study parameters/endpoints:
Primary endpoint is DASH SCORE. This endpoint will be measured with the DASH questionnaire (Disability of the Arm, Shoulder and Hand) Secondary endpoints will be the score on the CBSQ, VAS scale and SF 12. These endpoints will be measured with the CBSQ questionnaire (Cervical-Brachial Symptoms Questionnaire), VAS scale (Visual Analogue Scale for Pain) and SF 12 (Short Form 12 questionnaire)
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
All patients are operated with the same technique and by the same operator. There is a delay of 3 months for half of the subjects (control group), which is relative due to the early operation (in comparison with the existing waiting list for regular TOD of around 3 months) of the group that is randomised for TOD. There is no denial of 'optimal medical treatment' for any of the participating subjects.
- Conditions
- Neurogenic Thoracic Outlet Syndrome
- Being tested
- Thoracic outlet decompression
- Keywords
- thoracic outlet decompression (TOD)
- Medical subject headings
- Thoracic Outlet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic outlet decompressionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| TOD | Experimental | Thoracic Outlet Decompression (TOD) Receives: Procedure: Thoracic outlet decompression |
| Conservative therapy | No intervention | Physiotherapy and pain relief |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disability of the Arm, Shoulder and Hand (DASH) score
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).
Measured: Change in this outcome will be measured at 0, 3, 6, 12, 24, 36 and 60 months after inclusion
Secondary outcomes (3)
Chance in Cervical-Brachial Symptoms (CBSQ) Questionnaire score
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.
Measured: Change in this outcome will be measured at 0, 3, 6, 12, 24, 36 and 60 months after inclusion
Change in Visual Analogue Scale (VAS) for Pain
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.
Measured: Change in this outcome will be measured at 0, 3, 6, 12, 24, 36 and 60 months after inclusion
Change in Short Form 12 (SF-12) questionnaire score
This questionnaire measures quality of life. It consist out of 12 questions with answers going from Y/N to 0 to 5
Measured: Change in this outcome will be measured at 0, 3, 6, 12, 24, 36 and 60 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start1 Oct 2018
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Thoracic Outlet SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joep Teijink, Catharina Ziekenhuis Eindhoven
- Investigators
- Joep Teijink, MD, PhD, Principal investigator, Vascular surgeon - Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748602
- Sponsor's protocol ID
- NL63986.100.17
- Acronym
- STOPNTOS
- Status last verified
- Jul 2022
- First submitted
- 31 Oct 2018
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Thoracic Outlet Decompression Versus Conservative Approach for Patients With Neurogenic Thoracic Outlet Syndrome, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03748602
- Acronym / sponsor ID
- STOPNTOS / NL63986.100.17
- Conditions
- Neurogenic Thoracic Outlet Syndrome
- Keywords
- thoracic outlet decompression (TOD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Background:
Neurogenic thoracic outlet syndrome (NTOS) is a condition caused by compression and irritation of the brachial plexus serving the upper extremity. NTOS most frequently occurs in relatively young, active and otherwise healthy individuals and can have a tremendous impact on work, social and personal life. The diagnosis and therapy of NTOS still remains disputed. This is partly because diagnosis is largely clinical and subjective in nature, with no definitive (diagnostic) imaging or diagnostic studies available. As a result, disparities in the definition have produced different opinions regarding diagnostic standards for TOS. Furthermore, given the controversy surrounding the definition and diagnosis of TOS, conflict exists regarding the optimal treatment approach for this condition.
Studies in the last years, have shed light on some of the controversies in diagnosing and treating NTOS. Many patients that benefit from thoracic outlet decompression (TOD) do not fit the historical diagnostic criteria. Those patients (up to 90%) with disputed NTOS have shown improvement of symptoms and functionality after TOD surgery.
Recently, several studies have been published about outcome after TOD surgery for NTOS. These large, multicenter studies show a very low complication rate, ranging from 0-2%, with an extremely low risk of nerve injury.
These studies however report on heterogenous populations, diagnosed without any internationally validated diagnostic criteria. They hint beneficial results for TOD in NTOS patients, however the level of evidence they provide is low. Critics have wondered if the improvements - reported in these trials - are attributed to surgery, or are merely due to coincidence, selection bias, conservative treatment or time (rest).
The society of vascular surgery published reporting standards in 2016 to produce consistency in diagnosis, description of treatment and assessment of results to allow more valuable data to be reported. The investigators believe that a randomized controlled trial - using the reporting standards- could demonstrate the actual added value of a TOD (first rib resection with partial scalenectomy and neurolysis).
Objective:
The objective of this study is to determine the value of TOD (first rib resection with partial scalenectomy and neurolysis) on functionality and quality of life. This will be done by randomizing patients who already received conservative physiotherapy into surgery or continued conservative therapy (physiotherapy and pain relief). After 3 months, the patients with continued maximum conservative therapy will be offered surgery as well if complaints persist. The effect of TOD will be examined by following the change in functionality and quality of life compared to conservative physiotherapy. The durability of these effects on functional assessment and quality of life will also be examined by following patients for 5 years.
Study design:
Single center randomized controlled trial
Study population:
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.
Intervention:
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.
Main study parameters/endpoints:
Primary endpoint is DASH SCORE. This endpoint will be measured with the DASH questionnaire (Disability of the Arm, Shoulder and Hand) Secondary endpoints will be the score on the CBSQ, VAS scale and SF 12. These endpoints will be measured with the CBSQ questionnaire (Cervical-Brachial Symptoms Questionnaire), VAS scale (Visual Analogue Scale for Pain) and SF 12 (Short Form 12 questionnaire)
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
All patients are operated with the same technique and by the same operator. There is a delay of 3 months for half of the subjects (control group), which is relative due to the early operation (in comparison with the existing waiting list for regular TOD of around 3 months) of the group that is randomised for TOD. There is no denial of 'optimal medical treatment' for any of the participating subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TOD | Experimental | Procedure: Thoracic outlet decompressionThoracic Outlet Decompression (TOD) |
| Conservative therapy | No intervention | –Physiotherapy and pain relief |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- High suspicion of NTOS with high level of impairment.
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic outlet decompressionTOD 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. | Procedure or surgery | TOD |
Primary outcome
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).
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joep Teijink, MD, PhD principal investigator
Vascular surgeon - Catharina Ziekenhuis Eindhoven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic outlet decompression in people with Neurogenic Thoracic Outlet Syndrome, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.