Related ACE Reports
- Published: Dec 2014
- ACE Report #7461
Botulinum toxin A does not improve pain or ROM during tibal distraction osteogenesis
Study Type: Therapy
OE Level of Evidence: 2
Journal Level of Evidence: 2
Why was this study needed now?
Inadequate adaptation of soft tissues and strength imbalance of muscles remain major concerns in the tibial distraction osteogenesis, as they can lead to joint stiffness and pain. Botulinum toxin type A has been suggested as a possible treatment for these issues, as it is known to decrease muscle strength and tone. A pilot study has suggested BtX-A injections in patients undergoing distraction osteogenesis may decrease pain and increase the range of motion (ROM) at the joints surrounding the injection site, however, these findings did not achieve statistical significance as the pilot study was underpowered. This trial aimed to determine whether a BtX-A injection into the calf muscle at the time of tibial lengthening increases the ROM of surrounding joints and decreases calf pain in a larger sample of patients.
What was the principal research question?
Does the injection of botulinum toxin A in calf muscles following tibial distraction osteogenesis decrease calf pain and increase the range of motion when evaluated during a follow-up period of up to 39 months?
|Population:||36 patients undergoing bilateral tibial lengthening due to familial short stature. Patients received either the lengthening over nail technique or the lengthening then nailing technique. The same technique was used in both legs per the patient's decision. (Mean age: 23 [Range: 16-35]) (n=40 randomized; 36 analyzed)|
|Intervention:||Botulinum toxin A (BtX-A) injection: One leg of each patient was injected with 200 IU of BtX-A at the end of all procedures. Selection of the leg receiving the toxin was randomized. Injections were performed blind (no guidance) and were placed evenly at six different spots in the gastrocnemius and soleus muscles. Average distraction rate was 0.69mm/day with a mean tibial length increase of 64mm.|
|Comparison:||Saline injection: The other leg of each patient was injected with 20mL of saline at the end of all procedures. Blind injections were placed evenly at six different spots at the gastrocnemius and soleus muscles. Average distraction rate was 0.68mm/day with a mean tibial increase of 64mm.|
|Outcomes:||Outcomes assessed included knee and ankle range of motion, measured using a hand-held goniometer; pain over the gastrocnemius, soleus, and tibialis anterior muscle based on the visual analog pain (VAS) scale; and the maximal calf circumference of each leg.|
|Methods:||RCT; Double-blind; Single-center; Prospective|
|Time:||Patients were evaluated every 2 weeks throughout the distraction phase of around 3 months, and every month thereafter, up to a period of 39 months.|
What were the important findings?
What should I remember most?
How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.