Whiplash-induced Thoracic Outlet Syndrome Treated With Botulinum Toxin.

NCT05536570 | Unknown Phase 4

• 1 other identifier: EMSI-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Whiplash injuries following car accident are common, it has been reported to affect 83% of individuals injured in traffic collisions (Yadla S, 2007). The condition is caused by a rapid acceleration followed immediately by a rapid deceleration of the neck and head. The annual North American incidence rate is estimated to be 600 per 100,000 people (Holm LW, 2008). The condition is costly for society and disabling/painful for the patients. Depending on the collision type, the biomechanics of muscles will be affected differently and consequently the clinical presentation will vary. T-bone type of car collisions (when the front of one vehicle strikes the side of another) may induce thoracic outlet syndrome (TOS) following compression on the nerve and artery bundle by the scalene muscles (lateral stabilizers of the neck). An appropriate and detailed examination of the patient is necessary to identify the cause of the resulting pain and disability. Once a functional thoracic outlet syndrome is identified the proposal is to treat this with botulinum toxin.

Conditions

Thoracic Outlet Syndrome; Whiplash Injuries

Outcome Measures

Primary Outcomes (1)

• Change from baseline in pain disability as assessed using the PDQ at Week 4.

  PDQ before and after treatment. Pain Disability Questionnaire (Guides to the Evaluation of Permanent Impairment, Sixth Edition. 0= No pain related impairment 1-70= Mild pain related impairment 71-100=Moderate pain related impairment 101-130= Severe pain related impairment 131-150= Extreme pain related impairment

  week 4

Secondary Outcomes (3)

• Shoulder Elevation

  week 4

• Grip Strength

  Week 4

• Pinch Test

  WFeek 4

Interventions

IncobotulinumtoxinA 100 UNT DRUG

Scalene injection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have been diagnosed with a muscle strain to the lateral neck muscles following a car accident and there must be the following clinical signs of TOS: pain in the proper distribution, weakened grip, shoulder elevation on the appropriate side and numbness or tingling in the arm or fingers;
• Patient must have no signs suggesting a radiculopathy that could account for similar symptoms;
• Patient must have a PDQ \>70, i.e. in the moderate to very severe disability range;
• Patient must experience symptoms for longer than 3 months;
• Patient must have had the accident leading to whiplash within the last 3 years;
• Patient must be 18 years of age or older;
• Patient must be eligible and agreeable to treatment with BoNT-A;
• Patient must be toxin-naïve for the treatment of the cervical region, or have undergone a six months washout period;
• Patient must be English speaking;
• Patient must be able to provide informed consent.

You may not qualify if:

• Patient unable or unwilling to complete the necessary assessment tasks;
• Patient with hypersensitivity to botulinum neurotoxin type A or to any of the excipients, generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome), or infection or inflammation at the proposed injection site(s);
• Patient who requires physiotherapy and/or massage therapy;
• Patient for whom concomitant medications are not controlled at study start and/or may require change/adjustment during the study;
• Patient who had surgery which may interfere with the study;
• Women who are pregnant or nursing, or women in age of reproduction not using a contraceptive method;
• Patient in active litigation.

Sponsors & Collaborators

• King, David, MD: lead
• MERZ PHARMA: collaborator

Study Sites (1)

Private Office

Halifax, Nova Scotia, B3P 1M3, Canada

Location

MeSH Terms

Conditions

Thoracic Outlet Syndrome; Whiplash Injuries

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neck Injuries; Wounds and Injuries

Central Study Contacts

David B King, BSc, MD

CONTACT

902 425 7344; david.larkspur@gmail.com

Debbie Cavicchi, BA

CONTACT

902 425 7344; dking@davidbking.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist, Principal Investigator, Assistant Professor of Medicine

Model Details: Patients who have neck pain and arm paresthesia following a side-on collision

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: September 13, 2022
• Study Start: October 15, 2022
• Primary Completion: April 15, 2023
• Study Completion: June 15, 2023
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)