Complex Regional Pain Syndrome Clinical Trial
Official title:
"Efficacy of Botulinum Toxin Injection in Reducing Limb Pain in Patients With Complex Regional Pain Syndrome"
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | VA Connecticut Healthcare System | West Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
VA Connecticut Healthcare System | Allergan |
United States,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in the VAS score will be the primary outcome measure. | 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. | 7 months | |
Secondary | Quality of Life as a measure of function with pain. | 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. | 7 months | |
Secondary | Disability | 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. | 7 months | |
Secondary | Thermography | 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. | 7 months | |
Secondary | Goniometry | 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. | 7 months | |
Secondary | Algometry | 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. | 7 months | |
Secondary | Modified VAS Score | 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 months | |
Secondary | Electrical Impedence Myography | 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. | 7 months |
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