Recruiting
Early Phase 1

Botulinum Toxin

Sponsor:

VA Connecticut Healthcare System

Code:

NCT03616262

Conditions

Complex Regional Pain Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Botox + Lidocaine

Lidocaine alone

Study Details

Brief 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.

Conditions

Complex Regional Pain Syndrome

Study ID

NCT03616262

Start date

Jul, 2016

Status verified date

Jul, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Phase 1

In Phase 1, subjects will receive either Treatment A (Lidocaine alone) or Treatment B (Botox+Lidocaine )

active comparator: Phase 2

In Phase 2, subjects will receive either Treatment B (Botox+Lidocaine) or Treatment A (Lidocaine alone) -- the opposite of what was administered in Phase 1

Interventions

Botox + Lidocaine

The total dose per patient in the lower extremity or upper extremity will be based on common doses given in spasticity patients in the neurology injection clinic. If the target is a symptomatic arm, we will inject as follows: biceps 30 units, triceps 40 units, flexor carpi radialis 20 units, extensor carpi radialis 20 units. If the target is a symptomatic leg, we will inject in the following pattern: vastus lateralis 50 units, rectus femoris 30 units, medial gastrocnemius 40 units, tibialis anterior 40 units.

Lidocaine alone

The total dose per patient in the lower extremity or upper extremity will be based on common doses given in spasticity patients in the neurology injection clinic. If the target is a symptomatic arm, we will inject as follows: biceps 30 units, triceps 40 units, flexor carpi radialis 20 units, extensor carpi radialis 20 units. If the target is a symptomatic leg, we will inject in the following pattern: vastus lateralis 50 units, rectus femoris 30 units, medial gastrocnemius 40 units, tibialis anterior 40 units.

Primary outcome measure

  • Reduction in the VAS score will be the primary outcome measure. [ Time Frame: 7 months ]

Central Contacts and Locations

Central contacts

Sameer S Ali, MD

2032471860sameer.ali@sluhn.org

Locations

VA Connecticut Healthcare System

Recruiting

West Haven, Connecticut, United States, 06854

Contacts

Sameer Ali, MD

203-247-1860sameer.ali@sluhn.org

Principal Investigator:

Hajime Tokuno, MD

More Information

Sponsor

VA Connecticut Healthcare System

Last update posted

Aug 6, 2018

Last verified

Jul, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Connecticut Healthcare System on 2018-08-06.