Arthroscopic Stiff Elbow release and Botox
The Effect of Postoperative Administration of Botox vs Placebo (Normal Saline) on Elbow Range of Motion in Patients Undergoing Arthroscopic Osteocapsular Release for Patients with Elbow Contracture: A Pilot Triple-Blind Randomized Controlled Trial
John Trantalis
20 participants
Dec 15, 2022
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- 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 Criteria1
- Patients with past history of botulism, peripheral neuropathy, or myasthenia gravis.
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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 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.
Locations(1)
View Full Details on ANZCTR
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ACTRN12622001433796