N/A
N=18
Botulinum Toxin as a Novel Treatment for Prevention of Post-Traumatic Elbow Stiffness
Post Traumatic Stiffness
Bottom Line
View on ClinicalTrials.gov: NCT01129583 ↗Enrolled (actual)
18
Serious AEs
5.6%
Results posted
May 2011
Primary outcome: Primary: Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire — 27; 54 Scores on a Scale (0-100) — p=0.06
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Botulinum Toxin Type A (Drug); Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire |
27; 54 | 0.06 |
| SECONDARY Elbow Range of Motion |
103; 73 | 0.01 sig |
| SECONDARY Broberg Morrey Composite Elbow Function Score |
82; 65 | 0.02 sig |
Summary
This is a randomized double blind placebo controlled study to investigate the hypothesis that injection of botulinum toxin A into the muscles surrounding the elbow following the surgical treatment of an elbow fracture will reduce postoperative stiffness and improve function.
Eligibility Criteria
Inclusion Criteria
- Capable of providing informed consent
- 18 years old and older
- Elbow fractures that require operative intervention including:
- Supracondylar distal humerus fractures
- Intra-articular distal humerus fractures
- Proximal ulna and radius fractures
Exclusion Criteria
- Patients less than 18 years old
- Injuries that do not normally require surgical repair
- Patients with underlying spasticity
- Patients with burns about the elbow
- Patients with extensive soft tissue injuries of the elbow
- Patients with head or spinal cord injuries
- Myasthenia gravis, Eaton-Lambert, amyotrophic lateral sclerosis or any other disease that interferes with neuromuscular function
- Use of aminoglycoside antibiotics or other drug therapies that interfere with neuromuscular function
Data sourced from ClinicalTrials.gov (NCT01129583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.