"Efficacy of Botulinum Toxin Injection in Reducing Limb Pain in Patients With Complex Regional Pain Syndrome"

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Objective: The primary aim is to evaluate the efficacy of botulinum toxin A in reducing overall limb pain in patients with complex regional pain syndrome (CRPS). Additionally the investigators would like to see if quality of life is improved and disability scores decreased.

Research Design:

This is a double blinded, randomized cross-over study that will be conducted over a 7 month period. It is a pilot study that will include twenty subjects recruited from the Neurology CRPS clinic at VA Connecticut and from outside VA hospitals within a 150 mile radius. Subjects will receive an intramuscular injection Treatment A which is only 1% lidocaine or Treatment B which is mixture of botulinum toxin A + 1% lidocaine in the affected limb only. This is a cross over study where patients will receive Treatment A or B initially during the first of four study visits and during the third study visit while receive whichever treatment not given during the first visit. Dr. Sameer Ali, VA neurology fellow, will be blinded when administering the treatments. Dr. Hajime Tokuno, VA neurologist who is the principal investigator of the trial will prepare the treatments. Clinical pharmacy will be randomizing the treatments. Dr. Tokuno will not be blinded as he needs to know which treatment has been given in case of complications.

Impact/Significance: The significance of this study is the possible discovery of a new, safer, less invasive, and more efficacious therapeutic option for patients suffering from CRPS. Currently medical management with neuropathic pain meds, interventions such as sympathetic nerve blocks and ketamine infusion has helped some patients and not others. The investigators are trying to see whether either of the two treatments and especially the treatment with botulinum toxin may be a more viable alternative than existing modalities.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VA Connecticut Healthcare System
• Collaborator: Allergan
• Treatments: Botulinum Toxins; Lidocaine; onabotulinumtoxinA

Criteria

Inclusion Criteria:

1. All patients with documented diagnosis of CRPS per International Pain Society Guidelines. Diagnosis must be made or confirmed in the neurology CRPS clinic prior to recruitment.

2. Patients ages 18-80.

3. Patients may or may not have tried other therapeutics, will not affect study.

4. Veterans enrolled in the Veterans Hospital system of the United States.

5. Patients enrolled either type I or II CRPS of either upper or lower extremity.

Exclusion Criteria:

1. Prior history of adverse side effects with use of botulinum toxin.

2. Prior adverse reaction to lidocaine use.

3. CRPS involving multiple extremities.

4. Myasthenia gravis, myopathy, severe polyneuropathy or other causes of chronic muscle weakness.

5. History of severe mental illness or dementia.