A double-blind, placebo-controlled, randomized, delayed-start study is evaluating whether targeted IncobotulinumtoxinA, commonly known as Xeomin, may help reduce symptoms of neurogenic thoracic outlet syndrome.
This study is designed for patients with persistent pain, tingling, numbness, or weakness in the neck, shoulder, arm, or hand that may be related to nerve compression. The study uses ultrasound-guided injections to target muscles in the upper chest and neck that may be contributing to nerve compression.
All participants receive active treatment at some point during the study. This research may help evaluate a minimally invasive, non-surgical treatment option for a condition with limited available treatment pathways. The study is currently enrolling, and outcomes are pending.
Key Research Details
| Detail | Value |
|---|---|
| Principal Investigator | Jason W. Siefferman, MD |
| Sub-Investigator | Mariia Safroshkina, MD |
| Proposed Sponsor | Merz Pharmaceuticals GmbH, pending confirmation |
| Study Site | Manhattan Pain Medicine, PLLC, New York, NY |
| Study Type | Double-blind, placebo-controlled, randomized, delayed-start clinical study |
| Study Size | 44 participants |
| Estimated Participation Time | Approximately 25 weeks per participant |
| Enrollment Status | Currently enrolling |
| Primary Study Treatment | IncobotulinumtoxinA, commonly known as Xeomin |
| Condition Studied | Neurogenic thoracic outlet syndrome |
What This Study Involves
This study is evaluating whether targeted Xeomin injections may help reduce symptoms related to neurogenic thoracic outlet syndrome. Neurogenic thoracic outlet syndrome can cause pain, tingling, numbness, or weakness when nerves in the neck, shoulder, or upper chest region are compressed or irritated.
Participants are assigned to receive either Xeomin or saline during the first phase of the study. Because the study is double-blind, neither the participant nor the study assessors know which treatment is given at first. Participants in the placebo group cross over to active Xeomin treatment at week 12, so all participants receive active treatment during the study.
Study visits include two ultrasound-guided injection visits, one at week 0 and one at week 12, followed by a final follow-up visit at week 24. Participants complete symptom questionnaires at each visit to help track changes in arm, neck, shoulder, and upper limb symptoms over time.
Why This Research Matters
Neurogenic thoracic outlet syndrome can be difficult to treat, especially when symptoms persist despite conservative care. By studying targeted Xeomin injections, this trial may help determine whether relaxing specific muscles in the upper chest and neck can reduce nerve compression symptoms and provide a non-surgical option for selected patients.
Linked Conditions & Treatments
- Neurogenic thoracic outlet syndrome
- Xeomin, IncobotulinumtoxinA injections
- Nerve compression
- Upper limb pain
- Brachial plexus disorders
- Neck, shoulder, arm, and hand symptoms