"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:
Participant gender:
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.