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

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ClinicalTrials.gov Identifier: NCT03616262
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
VA Connecticut Healthcare System

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.


Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndrome Drug: Botox + Lidocaine Drug: Lidocaine alone Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: "Efficacy of Botulinum Toxin Injection in Reducing Limb Pain in Patients With Complex Regional Pain Syndrome"
Actual Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Active Comparator: Phase 1
In Phase 1, subjects will receive either Treatment A (Lidocaine alone) or Treatment B (Botox+Lidocaine )
Drug: 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.

Drug: 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.

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
Drug: 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.

Drug: 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 Measures :
  1. Reduction in the VAS score will be the primary outcome measure. [ Time Frame: 7 months ]
    The VAS score will be obtained using the VAS at each of the four study visits. Zero is no pain and ten is maximum pain on the zero to ten scale.


Secondary Outcome Measures :
  1. Quality of Life as a measure of function with pain. [ Time Frame: 7 months ]
    The Quality of Life scale will be utilized at each of the four study visits. We will be paying attention to change in the quality of life during this study. This scale is a measure of function for people with pain. zero=non functioning, ten=normal quality of life.

  2. Disability [ Time Frame: 7 months ]
    The Pain Disability Index scale will be utilized at each of the four study visits. We will be paying attention to change in disability during this study. This scale is designed to measure the degree that seven aspects of life are disrupted by chronic pain. These seven aspects are family/home responsibilities, recreation, social activity, occupation, sexual behavior, self care, life-support activities. This is a zero to ten scale with zero=no disability, and ten=worst disability.

  3. Thermography [ Time Frame: 7 months ]
    Digital infrared thermography can record heat emanation from pre-defined regions of interest (ROI) in affected area of the body, non-invasively. . The specific device that we will be utilizing is a FLIR A65 series medical grade IR thermography unit.

  4. Goniometry [ Time Frame: 7 months ]
    A goniometer (a.k.a. inclinometer) is a simple mechanical tool used by physiotherapists that can quickly and safely assess passive range of motion of individual limb joints. Contracture or dystonia of associated muscles will reduced the range of motion of the joint. The units of measure will be recorded in degrees change from the resting position to the fully flexed or extended position for a given joint. We will be using a digital goniometer known as the Baseline Absolute Axis 360 Degree Goniometer.

  5. Algometry [ Time Frame: 7 months ]
    An algometer is a device that measures pain thresholds in affected areas. We are recording the minimal pressure required to trigger a pain response at several pre-designated sites. The operator of the device will apply a steady force at a predefined site on an affected limb, and a digital readout of the pain threshold will be recorded in kilopascal units (kPa = Newtons/m2) per second. We will be utilizing a digital algometer designed by Wagner Instruments called the Force One Digital Force Gauge.

  6. Modified VAS Score [ Time Frame: 7 months ]
    This has been designed by our research team. This is comprised of asking for the average level of pain, lowest level of pain, highest level of pain for the day, allodynia, muscular pain component. These components are based on zero being no pain and ten being maximum pain on the zero to ten scale.

  7. Electrical Impedence Myography [ Time Frame: 7 months ]
    EIM assesses disease-induced changes in muscle tissue, including myocyte atrophy and loss, muscle edema, and fatty infiltration. It is new technology that is non invasive and safe. EIM uses high-frequency, low intensity electrical currents to quantify disuse atrophy and other muscle pathology.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616262


Contacts
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Contact: Sameer S Ali, MD 2032471860 sameer.ali@sluhn.org

Locations
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United States, Connecticut
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06854
Contact: Sameer Ali, MD    203-247-1860    sameer.ali@sluhn.org   
Sub-Investigator: Sameer S Ali, MD         
Sub-Investigator: Pavan Tankha, MD         
Principal Investigator: Hajime Tokuno, MD         
Sponsors and Collaborators
VA Connecticut Healthcare System
Allergan

Publications:

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Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT03616262     History of Changes
Other Study ID Numbers: VACHS
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Botulinum Toxins
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Acetylcholine Release Inhibitors
Cholinergic Agents
Neurotransmitter Agents