Can Botox® injection decrease lower leg pain caused by Chronic Exertional Compartment Syndrome (CECS)?
Summary
Chronic Exertional Compartment Syndrome (CECS) of the lower leg muscles significantly limits active individuals from participating in their desired sport activity to the best of their ability. Patients with CECS experience increased pressure in the lower leg muscles related to a restrictive fascia (envelope around the muscle or muscle group), resulting in pain during and after their sport activity. Diagnosis is confirmed with routine compartment pressure testing with a sport medicine physician.
This study will compare the effectiveness of Botox® to salt water injections in the affected lower leg muscles for decreasing pain related to sport activity in adults with a confirmed diagnosis of lower leg anterolateral Chronic Exertional Compartment Syndrome, over a 24-week follow-up period.
What is Involved?
1) Completion of online questionnaires at Baseline and 2, 4, 6, 8, 12, 16 and 24 weeks follow-up
2) In-person Baseline visit with physiatrists at the Kinesis Medical Centre to be randomized to receive either Botox® or salt water (normal saline) injection in the lower leg muscles
3) In-person follow-up visits at the University of Calgary Sport Medicine Centre at 6, 16 and 24 weeks after injection to measure muscle strength
4) In-person 12-week follow-up visit at the University of Calgary Sport Medicine Centre to perform compartment pressure testing and measure muscle strength
Eligibility
Eligible ages: 18 to 70
Accepts healthy participants: Yes
Inclusion criteria:
An individual may be eligible if they meet all of the following criteria:
1) Ages 18 years and older
2) Symptomatic anterolateral CECS during sport activity in one or both legs
3) Post-exertional compartment pressure measurements (as measured by the Sport Medicine Physician) of >30 mmHg immediately and >12 mmHg at 5 minutes after stopping exercise
Exclusion criteria:
An individual will NOT be eligible if they meet any of the following criteria:
1) Diagnosis of a condition other than anterolateral CECS
2) Lactating, pregnant or trying to get pregnant
3) History of keloidal scarring
4) Significant neurological disease (ie: amyotrophic lateral sclerosis, motor neuropathy, myasthenia gravis, Lambert-Eaton syndrome)
5) Previous botulinum injections in the lower leg compartment of the affected limb
6) Previous surgical fasciotomy of the affected leg
7) Previous lower limb injury (occurring within the last 6 months) that required medical intervention and treatment by a physician
8) Known allergic reaction to botulinum toxin
9) Does not speak, understand or read English language
Participate
Fill out the following form if you want to participate in this research
Collection of personal information
Your personal information is collected under
the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If
you have any questions about the collection or use of this information, please visit our
Access to Information page.
Additional information
Contact information
- With patient permission, physicians may send referrals to: Dr. Victor Lun or Dr. Preston Wiley University of Calgary Sport Medicine Centre 2500 University Drive NW Calgary, AB T2N 1N4 Fax: 403-282-6170 - Prospective patients may contact the CECS-Botox Study Research Coordinator: University of Calgary Sport Medicine Centre 2500 University Drive NW Calgary, AB T2N 1N4 cecs.study@ucalgary.ca Phone: 403-220-8944
Principal investigator:
Victor Lun
Clinical trial:
Yes
REB-ID:
REB22-0439