Chronic Exertional Compartment Syndrome (CECS) Treated With Abobotulinumtoxin A

NCT05466539 | Completed Phase 4 FDA Drug

• 1 other identifier: STUDY00003790
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic Exertional Compartment Syndrome (CECS) is a painful condition affecting runners and it is caused by a reversible increase in pressure within a closed compartment in the leg. Currently, to diagnose CECS, a large needle is placed into the muscle to measure pressure, which is invasive and painful. After diagnosis, the gold standard of treatment is surgery, which is also invasive, involves a prolonged return to play, and has a significant number of treatment failures. A growing literature has suggested alternative methods to both diagnosis and treatment that include the use of ultrasound to investigate muscle stiffness with shear wave elastography (SWE), and treatment with botulinum toxin injection into the muscle. The investigators propose a single-site randomized clinical trial to investigate the use of abobotulinumtoxinA in the treatment of CECS. Researchers also look to develop a non-invasive method for the diagnosis of CECS using SWE. To the researchers' knowledge, this is the first randomized study investigating the medication to treat this cause. The study will take place at Emory's outpatient sports medicine clinic. Potential participants will primarily be identified and recruited from the departments of Physical Medicine and Rehabilitation, Orthopedics, Physical Therapy, and Sports medicine as a part of regular clinical care. Participants will be included in the randomized portion of the study if they meet the previously established diagnostic criteria for CECS with compartmental pressure testing. This would be a landmark study to provide evidence for the use of an abobotulinumtoxinA in the treatment of CECS, leading to the potential avoidance of a surgical procedure. It could also change the means of diagnosis without the use of painful and invasive needle pressure testing that would provide patients and athletes with ease of care.

Conditions

Compartment Syndrome of Leg

Keywords

Runners; Lower extremity pain; Exertional Compartment Syndrome of the Leg

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline in the Visual Analog Scale (VAS) at 3 months following treatment

  Participants will be asked to complete questionnaires to evaluate their pain at each follow-up visit. The Visual Analog Scale will be the subjective measurement to evaluate changes in pain scores, with values ranging from 0 (no pain) to 10 (very severe pain). A higher score indicates worse pain

  Baseline and 3 months

Secondary Outcomes (9)

• Absolute change from baseline in the Visual Analog Scale (VAS) at 5 weeks following treatment

  Baseline and 5 weeks

• Absolute and Relative change from baseline in the Patient-Reported Outcomes from the University of Wisconsin Running Injury and Recovery Index (UWRI).

  Baseline, 5 weeks and 3 months

• Absolute and Relative change from baseline in the Ultrasound shear wave elastography measure: stiffness in kilopascals (kPa)

  Baseline, 5 weeks and 3 months

• Absolute and Relative change from baseline in the Ultrasound shear wave shear wave velocity (m/s) (SWE)

  Baseline, 5 weeks and 3 months

• Absolute and Relative change from baseline in the Single Assessment Numerical Evaluation (SANE)

  Baseline, 5 weeks and 3 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

AbobotulinumtoxinA

Drug: AbobotulinumtoxinA

Control Group

PLACEBO COMPARATOR

Normal Saline

Drug: Placebo

Interventions

AbobotulinumtoxinA DRUG

Participants randomized to receive aboBoNTA will receive a maximum of 200 units of aboBoNTA distributed across the following muscles: Targeted muscles will be selected from the Anterior (A) and Lateral (L) Compartments. They include (A) Tibialis Anterior (60 units), Extensor Digitorum Longus (20) and Extensor Hallucis Longus (20); (L) Fibularis Brevis (50) and Fibularis Longus (50). Tibialis Anterior (60U); Extensor Digitorum Longus (20); Extensor Halluces Longus (20); Fibularis Brevis (50), and; Fibularis longus (50). Treatment distribution across targeted muscles will be based on clinical presentation including muscle compartment(s) involvement as determined by ICP testing and SWE imaging.

Also known as: Intervention Group

Treatment Group

Placebo DRUG

Participants randomized into the normal saline group will receive injections distributed across the following muscles: Targeted muscles will be selected from the Anterior (A) and Lateral (L) Compartments. They include (A) Tibialis Anterior, Extensor Digitorum Longus, and Extensor Hallucis Longus; (L) Fibularis Brevis and Fibularis Longus. Tibialis Anterior; Extensor Digitorum Longus; Extensor Halluces Longus; Fibularis Brevis, and; Fibularis longus. Treatment distribution across targeted muscles will be based on clinical presentation including muscle compartment(s) involvement as determined by ICP testing.

Also known as: Control Group

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female runners aged 18-65 years
• Group providing normative values for SWE and needle manometry - ICP assessments

You may not qualify if:

• History of Neuromuscular disease, serious soft-tissue injury, fractures, and surgery to the lower limb(s).
• Treatment Groups:
• Confirmatory pressure values at diagnosis: Pre-exercise \> 15 mmHg; 1-min. post \> 30mmHg; or 5-min. post \> 20mmHg
• Ages 18-65 years inclusive at study onset.
• Ability to adhere to protocol.
• Botulinum toxin naïve (lower extremity). Others previously treated, \> than 6 mos. before study entry.
• Diagnosis of comorbid pain conditions, including claudication and/or popliteal artery entrapment syndrome.
• Serious soft tissue injury, fractures, or surgery in the lower limb(s) \< than 12 months before study entry.
• Current need for surgery at any level of the lower extremity.
• Treatment with any drug known to interfere with neuromuscular function (e.g., aminoglycoside antibiotics or neuromuscular blocking agents).
• Any other medical condition, laboratory, or diagnostic procedure finding that might preclude the administration of aboBoNTA (Dysport®).
• Ongoing infection at the injection sites.
• Diagnosed as either resistant or sensitive to botulinum toxin treatment of any type or to any components of Dysport®
• Cow milk protein allergy.
• Vulnerable patient populations such as adults unable to consent, pregnant women, prisoners, persons who have not obtained the legal age for consent to treatment or procedures

Sponsors & Collaborators

• Emory University: lead
• Ipsen: collaborator

Study Sites (2)

Emory Sports Medicine-Dunwoody

Atlanta, Georgia, 30338, United States

Location

Emory Hawks Sports Medicine Center

Brookhaven, Georgia, 30329, United States

Location

MeSH Terms

Interventions

abobotulinumtoxinA; Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Lee Kneer

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 20, 2022
• Study Start: April 25, 2024
• Primary Completion: August 13, 2025
• Study Completion: August 13, 2025
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The research team will share the available data beginning 9 months and ending 36 months following article publication
• Access Criteria: The research team will share the participant data with Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared to achieve the aims of the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be provided).

Locations

US (2)