RecruitingPhase 4ACTRN12622001433796

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


Sponsor

John Trantalis

Enrollment

20 participants

Start Date

Dec 15, 2022

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

A stiff elbow can be a debilitating problem, making it hard to perform everyday tasks like reaching, lifting, or using a computer. When conservative measures fail, surgery to release the scar tissue and tightened structures is often needed. This pilot study is exploring whether injecting botulinum toxin (Botox) into the biceps and brachialis muscles immediately before the surgical release might lead to a greater improvement in elbow movement afterward. The idea is that temporarily relaxing these muscles with Botox at the time of surgery may allow the elbow to move more freely during the critical early recovery period, before the muscles tighten again in response to the procedure. Participants will be randomly assigned to receive either Botox or a placebo injection before their surgery, and outcomes including range of motion and patient-reported function will be measured and compared. You may be eligible if you are aged 18 to 60, experience elbow stiffness, pain at the end of range of motion, or mechanical symptoms that suggest a physical block to movement. You would not be eligible if you have a history of botulism, peripheral neuropathy (nerve damage affecting the limbs), or myasthenia gravis (an autoimmune condition affecting muscle control).

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 bice

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)

NSW, Australia

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ACTRN12622001433796