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12 SCI volunteers completed the study. As the data analysis was negative, the decision was made not to proceed with MS recruitment.
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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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This study will examine the efficacy of Botulinum Toxin Type A ("Botox") in treating Allodynic-type neuropathic pain in people with spinal cord injury or multiple sclerosis.
Neuropathic pain is pain initiated or caused by injury to or disease of the nervous system, and is common in spinal cord injury patients or people with multiple sclerosis.
Allodynia is a type of neuropathic pain caused by something that normally would not cause pain, such as light touch, pressure from clothing, or bed sheets brushing against the skin.
Botox has been used to treat the muscle overactivity that causes spasticity in spinal cord injured patients. It has been noticed to exert some analgesic(pain relieving) effect, and has recently been studied as a treatment for neuropathic pain.
We want to see if Botox, injected intradermally, will relieve the symptoms of allodynic-type neuropathic pain.
24 volunteers are to be enrolled, with 16 receiving active treatment, and 8 "controls" receiving placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Botulinum Toxin Type A | Active Comparator | 200 units of Botulinum Toxin Type a will be administered intradermally to the allodynic area chosen for study.The allodynic area will be mapped, and the number of injections needed to cover the allodynic area without exceeding 40 injection sites will be determined. All participants will receive a cream formulation of lidocaine and prilocaine (EMLA) applied to the painful area 60 minutes before the injections to minimize any discomfort caused by the injections. |
|
| Arm 2: Normal Saline for Injection | Placebo Comparator | Normal saline for intradermal injection will be prepared by the Investigational Pharmacy in a manner as to be indistinguishable from active drug. The allodynic area will be mapped so as to determine the number of injections needed to cover the whole allodynic area without exceeding 40 injection sites. All participants will receive a cream formulation of lidocaine and prilocaine (EMLA) applied to the painful area 60 minutes before the injections to minimize any pain caused by the injections. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Drug |
| ||
| Normal Saline for Injection |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory | The primary outcome measure will be the self-reported average pain intensity from each morning's record in a diary. The average(self-reported) pain intensity will be measured at the screening visit, then the daily diary will be dispensed. The diary will ask for the average pain intensity of the last 24 hours using an 11-point numerical scale, with 0 representing no pain and 10 representing the worst pain imaginable | Baseline and daily until study completion at 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathic Pain Symptom Inventory | This scale rates the mean intensity of 10 neuropathic pain symptoms and their combination into 5 distinct dimensions during the last 24 hours on an 11-point (0-10) numerical scale | Baseline and follow-up visits(at weeks 1, 4, 8 and 13) |
| The Hospital Anxiety and Depression Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of brush-induced allodynia | The area of skin with allodynic pain is stroked with a standardized brush and the patient reports any pain associated with the stroking. | Baseline and follow-up visits(weeks 1, 4, 8 and 13) |
| Measurement of mechanical sensations and pain thresholds |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Ethans, MD | Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WRHA Health Sciences Centre Rehabilitation Hospital | Winnipeg | Manitoba | R3A IM4 | Canada |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| D007267 | Injections |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Drug |
|
14 items scored as anxiety and depression |
| Baseline and follow-up visits (at weeks 1, 4, 8 and 13). |
| Daily Sleep Interference Scale | Asks if pain interfered with sleep in the past 24 hours,using an 11-point scale (O-pain did not interfere with sleep, 10-pain completely interfered with sleep). Dispensed at baseline. | Baseline and daily during study period until week 13. |
| Clinician Global Impression Scale | Assesses the clinician's impression of Efficacy and Tolerability of study medication using a 4-point scale, with 1 being Very good, and 4 being Poor | Final visit at week 13 |
| Patient's Global Impression Scale | Measures the patients global impression of the efficacy and tolerability of the study medication on a 4-point scale, with 1 representing very good, and 4 representing poor | Final visit at week 13 |
An algometer (a device that pushes against the skin to measure when pain is felt) will be used on the allodynic area |
| Baseline and follow-up visits (weeks 1, 4 , 8 and 13) |
| Recording Area of allodynia | The area of allodynic pain to be treated is traced on transparent paper | Baseline and follow-up visits (at weeks 1, 4, 8 and 13) |
| Measurement of temperature sensations and pain thresholds | A thermo-test is used to measure temperature sensations and pain thresholds in the allodynic area | Baseline and follow-up visits(at weeks 1, 4, 8 and 13) |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |