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| ID | Type | Description | Link |
|---|---|---|---|
| 11830 |
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Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has also been reported to be helpful for some pain conditions. The investigators have observed prolonged profound analgesia following subcutaneous superficial injection of Botulinum Toxin Type A (BTA) in patients with certain types of neuropathic pain. The investigators propose to study if addition of BTA extends pain relief compared to placebo when injected subcutaneously into areas of cutaneous allodynia (the property that a normally non-noxious stimulus is perceived as painful).
Post-surgical neuromatous pain patients have marked cutaneous allodynia. Touching their skin with normally non-painful stimuli results in pain. Injected local anesthetics are often effective in providing temporary relief. In the course of clinical practice the investigators have observed that a number of patients with cutaneous allodynia have had marked persistent benefit from subcutaneous injection of Botulinum toxin Type A.
Rather than killing targeted neurons, Botulinum toxin type A inhibits release of acetylcholine from cholinergic nerve terminals in a prolonged but ultimately reversible manner. Neuropathic pain and its hallmark allodynia are classically difficult to treat. Standard treatment with tricyclic antidepressants, anti-epileptic drugs, opiates and spinal cord stimulation is frequently disappointing leaving patients with refractory pain. Surgical or percutaneous ablation of involved nerves has fallen out of favor among many due to disappointing results.
A pilot study is needed to assess the efficacy of superficially injected Botulinum Toxin type A for treatment of cutaneous allodynia and spontaneous pain among patients with neuropathic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo then Botox | Experimental |
| |
| Botox then Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin A | Drug | Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Until Analgesic Failure | Participants made daily NRS reports via Palm Pilot, and "failure" was defined as (Pre-injection baseline NRS) - (Mean NRS for any 3 preceding days) ≤ 0; or 9 months | Each participant was assessed for up to 224 days per intervention (injection) or until they returned to NRS baseline |
| Measure | Description | Time Frame |
|---|---|---|
| NRS Score Three Weeks After Injection | The NRS scores range from 0-100, where 0 indicated no pain and 100 indicated the worst pain. | Three weeks after injection |
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Inclusion Criteria:- Moderate to severe pain (greater than 4/10) of duration more than 6 months despite previous therapy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian R Carroll | Stanford University | Principal Investigator |
| Sean Mackey | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
84 total participants were enrolled. 46 were withdrawn before randomization due to failure at screening or following protocol. A total of 38 participants were randomized. A total of 30 participants remained for the first injection after 8 were withdrawn due to medication, surgery, or patient decision. A total of 27 participants completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Botox | Placebo - Saline: Subcutaneous Saline injection given at site of scar neuroma Botulinum Toxin A: Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin. |
| FG001 | Botox Then Placebo | Botulinum Toxin A: Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue Placebo - Saline: Subcutaneous Saline injection given at site of scar neuroma Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Injection Visit |
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| Washout (28 Days) |
| |||||||||||||
| Second Injection Visit |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Then Botox | Placebo - Saline: Subcutaneous Saline injection given at site of scar neuroma Botulinum Toxin A: Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue |
| BG001 | Botox Then Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Until Analgesic Failure | Participants made daily NRS reports via Palm Pilot, and "failure" was defined as (Pre-injection baseline NRS) - (Mean NRS for any 3 preceding days) ≤ 0; or 9 months | Posted | Mean | Standard Deviation | Days | Each participant was assessed for up to 224 days per intervention (injection) or until they returned to NRS baseline |
|
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Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Then Botox | Placebo - Saline: Subcutaneous Saline injection given at site of scar neuroma Botulinum Toxin A: Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab | Stanford University School of Medicine | (650) 498-6477 | smackey@stanford.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Placebo - Saline | Drug | Subcutaneous Saline injection given at site of scar neuroma |
|
| NOT COMPLETED |
|
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| NOT COMPLETED |
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Botulinum Toxin A:
Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue
Placebo - Saline:
Subcutaneous Saline injection given at site of scar neuroma
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | NRS Score Three Weeks After Injection | The NRS scores range from 0-100, where 0 indicated no pain and 100 indicated the worst pain. | Although 27 participants completed the study, 3 participants were excluded from analysis of the NRS score because they had missing data. | Posted | Mean | Standard Deviation | Units on a scale | Three weeks after injection |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 8 |
| 13 |
| EG001 | Botox Then Placebo | Placebo - Saline: Subcutaneous Saline injection given at site of scar neuroma Botulinum Toxin A: Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin. | 0 | 14 | 0 | 14 | 10 | 14 |
| Dyspepsia | General disorders | Systematic Assessment |
|
| Injection site pain | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Flu symptoms | General disorders | Systematic Assessment |
|
| Torticollis | General disorders | Systematic Assessment |
|
| Arthralgia | General disorders | Systematic Assessment |
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| Back pain | General disorders | Systematic Assessment |
|
| Increased cough | General disorders | Systematic Assessment |
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| Increased weakness | General disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
|
| Rhinitis | General disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
|
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| 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 |