Whiplash-induced Thoracic Outlet Syndrome Treated With Botulinum Toxin.

• Status: Not yet recruiting
• Trial end date: 2023-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King, David, MD
• Collaborator: MERZ PHARMA
• Treatments: incobotulinumtoxinA

Criteria

Inclusion Criteria:

• • 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.

Exclusion Criteria:

• • 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.