Treatment of Lower Leg Anterolateral Chronic Exertional Compartment Syndrome With Intra-muscular Botulinum Injections.

NCT05765071 | Unknown

• 1 other identifier: REB22-0439
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this pilot triple-blind randomized clinical trial is to determine the effectiveness of intra-muscular botulism injection for treatment of lower leg anterolateral chronic exertional compartment syndrome (CECS). Primary Research Question: What is the effectiveness of intra-muscular botulinum injection, compared to normal saline placebo, for reducing pain related to painful sport activity in patients with lower leg anterolateral chronic exertional compartment syndrome (CECS), over a 24-week period? Secondary outcomes will measure the time to initial onset and duration of pain during the painful sport activity, characterize the type of pain, foot paraesthesias, self-reported ankle instability, and ankle dorsiflexion and eversion muscle power. The Single Assessment Numeric Evaluation (SANE) score will provide a measure of overall leg function. Adult patients with a confirmed diagnosis of anterolateral CECS, as determined by post-exertional compartment pressure measurements, will be invited to participate in the study. Using concealed, consecutively-numbered randomization envelopes, participants will be randomly assigned to receive either the botulinum (treatment) or the normal saline (control) injection. Participants will answer a web-based outcome questionnaire at Baseline (prior to receiving the injection) and at 2, 4, 6, 8, 12, 16, 24-weeks follow-up. Participants will be asked to do their painful sport activity the day before completing the questionnaire. Ankle dorsiflexion and eversion muscle power will be manually measured by a physiatrist in clinic at 6, 16 and 24-week follow-up visits.

Conditions

Chronic Exertional Compartment Syndrome

Keywords

anterolateral; CECS; lower leg

Outcome Measures

Primary Outcomes (1)

• Change in maximum level of pain at time of painful sport activity from Baseline to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection

  Pain measured on a visual analog scale from 0 to 100, where 0 represents no pain and 100 represents pain as bad as it can be

  Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection

Secondary Outcomes (8)

• Change in time to onset of pain during sport activity (minutes)

  Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection

• Change in duration of exercise before having to stop due to pain (minutes)

  Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection

• Change in duration of pain after stopping painful exercises (minutes)

  Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection

• Change in the numbness and/or tingling in foot during painful exercises from Baseline to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection

  Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection

• Change in ankle dorsiflexion muscle power from Baseline to 6, 16 and 24-weeks post-injection

  Baseline, and 6, 16 and 24-weeks post-injection

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Botulinum toxin (Botox) injection

Biological: Botulinum toxin A

Control

PLACEBO COMPARATOR

Normal saline injection

Biological: Normal saline

Interventions

Botulinum toxin A BIOLOGICAL

Botulinum injections will be prepared by diluting 100 units of botulinum toxin A with 5.0mL of saline (20.0U/mL). A total of 100 units (5.0mL) of botulinum toxin A will be injected into the tibialis anterior, peroneus longus and peroneus brevis muscles of the affected leg. Under ultrasound guidance, the injectant will be deposited at two sites in each muscle near the motor points.

Also known as: Botox

Treatment

Normal saline BIOLOGICAL

A total of 5.0mL of normal saline will be injected into the tibialis anterior, peroneus longus and peroneus brevis muscles of the affected leg. Under ultrasound guidance, the injectant will be deposited at two sites in each muscle near the motor points.

Also known as: Placebo

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Confirmed diagnosis of lower leg anterolateral chronic exertional compartment syndrome (CECS), as measured post-exertional compartment pressure measurements of greater than 30 mmHg for immediate post-exertional compartment pressure, and greater than 12 mmHg at 5 minutes after stopping exercise.

You may not qualify if:

• Female patients who are pregnant, trying to get pregnant or lactating
• History of keloidal scarring
• History of any significant neurologic disease (ie: amyotrophic lateral sclerosis, motor neuropathy, myasthenia gravis, Lambert-Eaton syndrome)

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Academy of Sport and Exercise Medicine (CASEM): collaborator
• Kinesis Medical Centre Inc.: collaborator

MeSH Terms

Conditions

Chronic Exertional Compartment Syndrome

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Victor Lun

  University of Calgary Sport Medicine Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Lun, MD

CONTACT

403-220-8518; vmylun@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to the treatment they received until after the 24-week visit is completed. The physiatrist administering the injection and the physiatrist performing the manual muscle power assessments will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants receiving botulinum toxin will be compared to those receiving normal saline.

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 13, 2023
• Study Start: June 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: June 1, 2024
• Last Updated: May 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share