None listed
Conditions
Brief summary
This pilot study aims to compare patient-rated outcomes and range of motion between patients who undergo surgical stiff elbow release, treated with an injection of botulinum toxin (botox) pre-surgery vs placebo. We hypothesized that the injection of botox into the biceps and brachialis immediately before surgery may result in greater range of motion (less stiffness) following surgical release.
Interventions
The dependent variable (intervention) will be 100 units of Botulinum toxin reconstituted with 2 cc of Normal Saline, introduced using a one-off intramuscular injection into the bifurcation of the biceps in the upper arm and the brachialis at the level of the elbow joint, under ultrasound guidance by the anesthetist postoperatively, at the time when the anesthetist inserts a pain catheter for postoperative pain control for patients undergoing arthroscopic osteocapsular release for elbow contractu
The dependent variable (intervention) will be 100 units of Botulinum toxin reconstituted with 2 cc of Normal Saline, introduced using a one-off intramuscular injection into the bifurcation of the biceps in the upper arm and the brachialis at the level of the elbow joint, under ultrasound guidance by the anesthetist postoperatively, at the time when the anesthetist inserts a pain catheter for postoperative pain control for patients undergoing arthroscopic osteocapsular release for elbow contractures. As this trial aims compare the effect of a one-off administration of the intervention (botulinum toxin reconstituted with normal saline) compared to a one-off administration of a placebo (normal saline only) pre-surgery, adherence to the intervention is not applicable. All other processes of arthroscopic osteocapsular release for elbow contractures will occur as per usual standard care.
Sponsors
John Trantalis
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Patient complains of elbow stiffness, end of range of motion pain, and/or mechanical symptoms consistent with a mechanical block to range of motion.
Exclusion criteria
Patients with past history of botulism, peripheral neuropathy, or myasthenia gravis.
Outcome results
None listed