Neuropathic Back Pain, Spinal Cord Injury
Conditions
Keywords
Botulinum Toxin A, Neuropathic pain, Spinal cord injury, Pain management, Rehabilitation
Brief summary
Back pain is a common secondary condition of both acute and chronic spinal cord injury (SCI). Current existing treatment including both pharmacologic and non-pharmacologic are limited by marginal efficacy or intolerable side effects. The purpose of this study is to evaluate the potential of subcutaneous injections of botulinum toxin A to provide pain relief in spinal cord injury patients with back pain near the level of injury in the spine. Botulinum toxin A has been shown in both pre-clinical and clinical studies to help with nerve pain. The researchers propose a double blinded placebo controlled crossover study to study the effects of subcutaneous botulinum injections to at--level SCI back pain in patients with spinal cord injury.
Detailed description
In this study, there will be 2 procedure performed. The first procedure will be named P1 and consists of subcutaneous injection of either placebo or Botulinum Toxin A. The second procedure will be the cross-over procedure named P2. For the cross-over procedure, the subjects who had initially received Botulinum Toxin A will receive placebo and the subjects who had initially received placebo will receive Botulinum Toxin A. This is a Randomized Double-Blinded Placebo Controlled Trial. Recruited subjects will be consented, enrolled and evaluated immediately prior to P1 (or during a visit prior to the visit for P1). After the initial pre-treatment evaluation, subjects will randomly receive either placebo or Botulinum Toxin A subcutaneously (P1). A telephone follow-up (or e-mail follow up) will be performed at 2 weeks and 8 weeks post- P1. An onsite follow up will be performed 4 weeks post P1 and 12 weeks post P1. Cross-over Study: After the 3rd month on-site evaluation (12 weeks post P1), during the same visit, the subject will proceed to the cross-over study. At this time, the patient will have the option to receive a repeat subcutaneous injection of the cross-over agent. If they desire one, a subcutaneous injection of the cross-over agent will be performed at that same visit. If they wish to defer the repeat injection, they will be contacted and asked every 4 weeks - between 12 weeks and 24 weeks post P1 (no subject will receive P2 after week 24) if they would like to have the subcutaneous injection of the cross-over agent. If they desire one, a repeat injection will be scheduled for the following week. The rationale for a variable length of time after the initial Botulinum Toxin A/Placebo injection (P1) is to document the variability of individuals' pain response after Botulinum Toxin A. It has been reported in literature, of the subjects that respond to subcutaneous Botulinum Toxin A injections for pain, most will return to their base-line pain score in 12--24 weeks.
Interventions
DRUGBotulinum Toxin A
Subjects will receive subcutaneous Botulinum Toxin A injections into the marked painful region. The syringes will be prepared by a third party prior to the injection and the administrator of the procedure will be blinded to syringe content. This physician will be performing the injections under sterile conditions. Local anesthesia, EMLA (lignocaine/prilocaine eutectic mixture) cream, up to 4 grams, will be applied topically for local anesthesia. After 50 minutes, the cream will be cleaned off. Overlying skin will be sterilized with either betadine or alcohol solution.
DRUGPlacebo
Subjects will receive subcutaneous placebo injections into the marked painful region. The syringes will be prepared by a third party prior to the injection and the administrator of the procedure will be blinded to syringe content. This physician will be performing the injections under sterile conditions. Local anesthesia, EMLA (lignocaine/prilocaine eutectic mixture) cream, up to 4 grams, will be applied topically for local anesthesia. After 50 minutes, the cream will be cleaned off. Overlying skin will be sterilized with either betadine or alcohol solution.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Between the ages of 18 and 80 years old * Diagnosed with traumatic spinal cord injury * Target pain is considered by the physician as at-level SCI in nature to a high degree of certainty (4 or 5 using a Likert confidence scale ranging from 0-5 where 0 is purely a guess and 5 is absolutely certain) * Able to give written informed consent * Target pain that has been continuously present for at least one month * Target pain is of at least moderate average intensity over the past week, e.g., greater than or equal to 4/10 on a numeric rating scale, the cutoff point for moderate pain in an SCI population. * Target pain is localized within the dermatome which identifies the NLI or within 3 levels below the NLI * Subject has been on a stable dose of analgesic mediation (or not on analgesic medication) for at least 3 weeks and is agreeable to remaining on current regimen for the duration of the study (previous prescribed breakthrough analgesics will be allowed)
Exclusion criteria
* Pregnancy * History of intolerance, hypersensitivity or known allergy to botulinum toxin or its preservatives * History of intolerance, hypersensitivity or known allergy to EMLA cream (lignocaine/prilocaine eutectic mixture) which is used as an analgesic during BoNT injection * Recent history of administration of botulinum toxin (within previous 6 months) * Contraindications to botulinum toxin (myasthenia gravis or other disease of the neuromuscular junction) * Coagulation disorder * Current infection * Insufficient command of English to complete self-report instruments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | up to 12 weeks post-injection, for a total of 24 weeks from baseline | Participant rated pain intensity from 0-10, with higher score indicating more pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Basic Pain Dataset - Pain Affecting Day-to-day Activities | up to 12 weeks post-injection, for a total of 24 weeks from baseline | The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting day-to-day activities subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes. |
| International Basic Pain Dataset - Pain Affecting Mood | up to 12 weeks post-injection, for a total of 24 weeks from baseline | The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting mood subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes. |
| International Basic Pain Dataset - Pain Affecting Sleep | up to 12 weeks post-injection, for a total of 24 weeks from baseline | The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting sleep subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes. |
| 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | up to 12 weeks post-injection, for a total of 24 weeks from baseline | Mean change from baseline. Participants are asked Taking into account your pain level and how it affects your life, are you feeling better, the same or worse than when you started treatment? and then to quantify the magnitude of the change. with the 7-Point guy Farrar which measures the global treatment effect from with scale from 0 to 6, higher score indicates worse outcomes. |
| Dynamic Mechanical Allodynia Testing | up to 12 weeks post-injection, for a total of 24 weeks from baseline | Dynamic allodynia will be tested by stroking the affected region gently with a cotton swab, 4 times at a rate of 3-5cm per second over an area of 5cm. If there is an evoked clear sensation of pain, the subject is asked to rate the intensity of dynamic allodynia using the 11-point NRS. The region of static and dynamic allodynia, if present, will be marked and recorded |
| Patient-generated Index (PGI) | up to 12 weeks post-injection, for a total of 24 weeks from baseline | PGI measures activity affected by pain. Full score is 0 to 10000, with higher score indicating better function |
| Static Mechanical Allodynia Testing | up to 12 weeks post-injection, for a total of 24 weeks from baseline | Mechanical allodynia is a characteristic of evoked pain in subjects with neuropathic pain. Static allodynia to mechanical stimuli will be defined as a sensation of pain evoked by the pressure of the end of a wooden stick. The end of a wooden stick will touch the affected region with enough pressure to indent the skin, for 10 seconds. Afterwards, the subject will be asked to rate the perceived pain on an 11-point NRS. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin A Then Placebo Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks, then Placebo 0.2mL of 0.9% normal saline for 12 weeks. | 5 |
| Placebo Then Botulinum Toxin A Placebo 0.2mL of 0.9% normal saline for 12 weeks, then Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks. | 3 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Crossover Next 12 Weeks | Lost to Follow-up | 1 | 2 |
| Crossover Next 12 Weeks | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Placebo Then Botulinum Toxin A | Botulinum Toxin A Then Placebo |
|---|---|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 9.21 | 36.7 years STANDARD_DEVIATION 4.04 | 50.6 years STANDARD_DEVIATION 7.02 |
| DN4 screen (neuropathic >4) Brushing | 3 Participants | 1 Participants | 2 Participants |
| DN4 screen (neuropathic >4) Burning | 6 Participants | 2 Participants | 4 Participants |
| DN4 screen (neuropathic >4) Electric shock | 5 Participants | 2 Participants | 3 Participants |
| DN4 screen (neuropathic >4) Hypoesthesia to prick | 2 Participants | 1 Participants | 1 Participants |
| DN4 screen (neuropathic >4) Hypoesthesia to touch | 3 Participants | 1 Participants | 2 Participants |
| DN4 screen (neuropathic >4) Itching | 3 Participants | 2 Participants | 1 Participants |
| DN4 screen (neuropathic >4) Numbness | 5 Participants | 1 Participants | 4 Participants |
| DN4 screen (neuropathic >4) Painful cold | 3 Participants | 2 Participants | 1 Participants |
| DN4 screen (neuropathic >4) Pins and needles | 8 Participants | 3 Participants | 5 Participants |
| DN4 screen (neuropathic >4) Tingling | 7 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown/Not reported | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 1 Participants | 1 Participants |
| SCIPI screen (neuropathic >=3) All the time when awake | 8 Participants | 3 Participants | 5 Participants |
| SCIPI screen (neuropathic >=3) Burning or freezing | 4 Participants | 2 Participants | 2 Participants |
| SCIPI screen (neuropathic >=3) Electric shock | 5 Participants | 2 Participants | 3 Participants |
| SCIPI screen (neuropathic >=3) No feeling in area | 2 Participants | 0 Participants | 2 Participants |
| SCIPI screen (neuropathic >=3) Pins and needles | 8 Participants | 3 Participants | 5 Participants |
| SCIPI screen (neuropathic >=3) Sensitive | 4 Participants | 3 Participants | 1 Participants |
| SCIPI screen (neuropathic >=3) Unchanged with movement | 8 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 1 / 8 | 0 / 8 |
| serious Total, serious adverse events | 1 / 8 | 0 / 8 |
Outcome results
Primary
Numeric Pain Rating Scale (NPRS)
Participant rated pain intensity from 0-10, with higher score indicating more pain
Time frame: up to 12 weeks post-injection, for a total of 24 weeks from baseline
Population: only those who completed crossover were included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin A Then Placebo | Numeric Pain Rating Scale (NPRS) | 2 week post injection | 6.4 score on a scale | Standard Deviation 0.9 |
| Botulinum Toxin A Then Placebo | Numeric Pain Rating Scale (NPRS) | crossover 2 week follow up | 8 score on a scale | Standard Deviation 0 |
| Botulinum Toxin A Then Placebo | Numeric Pain Rating Scale (NPRS) | 8 week post injection | 5.6 score on a scale | Standard Deviation 2.6 |
| Botulinum Toxin A Then Placebo | Numeric Pain Rating Scale (NPRS) | crossover 4 week follow up | 8 score on a scale | Standard Deviation 0 |
| Botulinum Toxin A Then Placebo | Numeric Pain Rating Scale (NPRS) | 4 week post injection | 5.6 score on a scale | Standard Deviation 1.7 |
| Botulinum Toxin A Then Placebo | Numeric Pain Rating Scale (NPRS) | crossover 8 week follow up | 6.7 score on a scale | Standard Deviation 1.5 |
| Botulinum Toxin A Then Placebo | Numeric Pain Rating Scale (NPRS) | 12 week post injection | 5.6 score on a scale | Standard Deviation 3.3 |
| Botulinum Toxin A Then Placebo | Numeric Pain Rating Scale (NPRS) | crossover 12 week follow up | 8 score on a scale | Standard Deviation 1 |
| Botulinum Toxin A Then Placebo | Numeric Pain Rating Scale (NPRS) | baseline | 7.6 score on a scale | Standard Deviation 1.5 |
| Placebo Then Botulinum Toxin A | Numeric Pain Rating Scale (NPRS) | crossover 12 week follow up | 7 score on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | Numeric Pain Rating Scale (NPRS) | baseline | 8 score on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | Numeric Pain Rating Scale (NPRS) | 2 week post injection | 8 score on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | Numeric Pain Rating Scale (NPRS) | 4 week post injection | 8 score on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | Numeric Pain Rating Scale (NPRS) | 8 week post injection | 8 score on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | Numeric Pain Rating Scale (NPRS) | 12 week post injection | 8 score on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | Numeric Pain Rating Scale (NPRS) | crossover 2 week follow up | 5 score on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | Numeric Pain Rating Scale (NPRS) | crossover 4 week follow up | 5 score on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | Numeric Pain Rating Scale (NPRS) | crossover 8 week follow up | 6 score on a scale | Standard Deviation 0 |
Secondary
7-Point Guy/Farrar Patient Global Impression of Change (PGIC)
Mean change from baseline. Participants are asked Taking into account your pain level and how it affects your life, are you feeling better, the same or worse than when you started treatment? and then to quantify the magnitude of the change. with the 7-Point guy Farrar which measures the global treatment effect from with scale from 0 to 6, higher score indicates worse outcomes.
Time frame: up to 12 weeks post-injection, for a total of 24 weeks from baseline
Population: only those who completed crossover were included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin A Then Placebo | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | 2 week post injection | 2.2 score on a scale | Standard Deviation 2.2 |
| Botulinum Toxin A Then Placebo | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | crossover 2 week follow up | 0 score on a scale | Standard Deviation 0 |
| Botulinum Toxin A Then Placebo | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | 8 week post injection | 2 score on a scale | Standard Deviation 1.6 |
| Botulinum Toxin A Then Placebo | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | crossover 4 week follow up | 0 score on a scale | Standard Deviation 0 |
| Botulinum Toxin A Then Placebo | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | 4 week post injection | 2.4 score on a scale | Standard Deviation 1.5 |
| Botulinum Toxin A Then Placebo | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | crossover 8 week follow up | 0 score on a scale | Standard Deviation 0 |
| Botulinum Toxin A Then Placebo | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | crossover 12 week follow up | 0 score on a scale | Standard Deviation 0 |
| Botulinum Toxin A Then Placebo | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | 12 week post injection | 2 score on a scale | Standard Deviation 1.9 |
| Placebo Then Botulinum Toxin A | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | crossover 12 week follow up | 1 score on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | 2 week post injection | 0.3 score on a scale | Standard Deviation 0.6 |
| Placebo Then Botulinum Toxin A | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | 4 week post injection | 0.3 score on a scale | Standard Deviation 0.6 |
| Placebo Then Botulinum Toxin A | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | 8 week post injection | 0 score on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | 12 week post injection | 0 score on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | crossover 2 week follow up | 5 score on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | crossover 4 week follow up | 5 score on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | crossover 8 week follow up | 3 score on a scale | Standard Deviation 0 |
Secondary
Dynamic Mechanical Allodynia Testing
Dynamic allodynia will be tested by stroking the affected region gently with a cotton swab, 4 times at a rate of 3-5cm per second over an area of 5cm. If there is an evoked clear sensation of pain, the subject is asked to rate the intensity of dynamic allodynia using the 11-point NRS. The region of static and dynamic allodynia, if present, will be marked and recorded
Time frame: up to 12 weeks post-injection, for a total of 24 weeks from baseline
Population: Data initially collected incorrectly, then data not collected.
Secondary
International Basic Pain Dataset - Pain Affecting Day-to-day Activities
The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting day-to-day activities subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes.
Time frame: up to 12 weeks post-injection, for a total of 24 weeks from baseline
Population: only those who completed crossover were included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | 2 week post injection | 5.4 units on a scale | Standard Deviation 1.5 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | crossover 2 week follow up | 7 units on a scale | Standard Deviation 1.7 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | 8 week post injection | 5 units on a scale | Standard Deviation 1.6 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | crossover 4 week follow up | 6.7 units on a scale | Standard Deviation 2.3 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | 4 week post injection | 5 units on a scale | Standard Deviation 1.2 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | crossover 8 week follow up | 7 units on a scale | Standard Deviation 2.6 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | 12 week post injection | 4.8 units on a scale | Standard Deviation 2 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | crossover 12 week follow up | 6.7 units on a scale | Standard Deviation 3.2 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | Baseline | 4.2 units on a scale | Standard Deviation 4.1 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | crossover 12 week follow up | 5 units on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | Baseline | 5.3 units on a scale | Standard Deviation 4.6 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | 2 week post injection | 2.7 units on a scale | Standard Deviation 4.6 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | 4 week post injection | 2.7 units on a scale | Standard Deviation 4.6 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | 8 week post injection | 2.7 units on a scale | Standard Deviation 4.6 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | 12 week post injection | 2.7 units on a scale | Standard Deviation 4.6 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | crossover 2 week follow up | 2 units on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | crossover 4 week follow up | 3 units on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | crossover 8 week follow up | 4 units on a scale | Standard Deviation 0 |
Secondary
International Basic Pain Dataset - Pain Affecting Mood
The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting mood subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes.
Time frame: up to 12 weeks post-injection, for a total of 24 weeks from baseline
Population: only those who completed crossover were included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Mood | 2 week post injection | 6.6 units on a scale | Standard Deviation 2.3 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Mood | crossover 2 week follow up | 7 units on a scale | Standard Deviation 1.7 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Mood | 8 week post injection | 5.2 units on a scale | Standard Deviation 0.8 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Mood | crossover 4 week follow up | 7 units on a scale | Standard Deviation 1.7 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Mood | 4 week post injection | 5.8 units on a scale | Standard Deviation 1.5 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Mood | crossover 8 week follow up | 7.3 units on a scale | Standard Deviation 2.1 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Mood | 12 week post injection | 5.6 units on a scale | Standard Deviation 1.8 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Mood | crossover 12 week follow up | 6.7 units on a scale | Standard Deviation 3.2 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Mood | Baseline | 5.6 units on a scale | Standard Deviation 3.5 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Mood | crossover 12 week follow up | 7 units on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Mood | Baseline | 5.7 units on a scale | Standard Deviation 4.9 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Mood | 2 week post injection | 2.7 units on a scale | Standard Deviation 4.6 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Mood | 4 week post injection | 2.7 units on a scale | Standard Deviation 4.6 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Mood | 8 week post injection | 4.3 units on a scale | Standard Deviation 4.5 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Mood | 12 week post injection | 5.7 units on a scale | Standard Deviation 4.9 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Mood | crossover 2 week follow up | 2 units on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Mood | crossover 4 week follow up | 3 units on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Mood | crossover 8 week follow up | 4 units on a scale | Standard Deviation 0 |
Secondary
International Basic Pain Dataset - Pain Affecting Sleep
The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting sleep subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes.
Time frame: up to 12 weeks post-injection, for a total of 24 weeks from baseline
Population: only those who completed crossover were included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Sleep | 2 week post injection | 4.6 units on a scale | Standard Deviation 3.6 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Sleep | crossover 2 week follow up | 8 units on a scale | Standard Deviation 0 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Sleep | 8 week post injection | 6 units on a scale | Standard Deviation 1.6 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Sleep | crossover 4 week follow up | 8 units on a scale | Standard Deviation 0 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Sleep | 4 week post injection | 5 units on a scale | Standard Deviation 2.3 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Sleep | crossover 8 week follow up | 8 units on a scale | Standard Deviation 0 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Sleep | 12 week post injection | 6.2 units on a scale | Standard Deviation 2.2 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Sleep | crossover 12 week follow up | 7.3 units on a scale | Standard Deviation 2.1 |
| Botulinum Toxin A Then Placebo | International Basic Pain Dataset - Pain Affecting Sleep | Baseline | 5.8 units on a scale | Standard Deviation 3.8 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Sleep | crossover 12 week follow up | 5 units on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Sleep | Baseline | 6.7 units on a scale | Standard Deviation 2.3 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Sleep | 2 week post injection | 4.7 units on a scale | Standard Deviation 3.1 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Sleep | 4 week post injection | 3.3 units on a scale | Standard Deviation 4.2 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Sleep | 8 week post injection | 6 units on a scale | Standard Deviation 2 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Sleep | 12 week post injection | 6.7 units on a scale | Standard Deviation 2.3 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Sleep | crossover 2 week follow up | 1 units on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Sleep | crossover 4 week follow up | 3 units on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | International Basic Pain Dataset - Pain Affecting Sleep | crossover 8 week follow up | 4 units on a scale | Standard Deviation 0 |
Secondary
Patient-generated Index (PGI)
PGI measures activity affected by pain. Full score is 0 to 10000, with higher score indicating better function
Time frame: up to 12 weeks post-injection, for a total of 24 weeks from baseline
Population: only those who completed crossover were included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin A Then Placebo | Patient-generated Index (PGI) | 2 week post injection | 5240 score on a scale | Standard Deviation 1892.9 |
| Botulinum Toxin A Then Placebo | Patient-generated Index (PGI) | crossover 2 week follow up | 3333.3 score on a scale | Standard Deviation 763.8 |
| Botulinum Toxin A Then Placebo | Patient-generated Index (PGI) | 8 week post injection | 3725 score on a scale | Standard Deviation 1492.5 |
| Botulinum Toxin A Then Placebo | Patient-generated Index (PGI) | crossover 4 week follow up | 3333.3 score on a scale | Standard Deviation 763.8 |
| Botulinum Toxin A Then Placebo | Patient-generated Index (PGI) | 4 week post injection | 5219 score on a scale | Standard Deviation 2130.8 |
| Botulinum Toxin A Then Placebo | Patient-generated Index (PGI) | crossover 8 week follow up | 3333.3 score on a scale | Standard Deviation 763.8 |
| Botulinum Toxin A Then Placebo | Patient-generated Index (PGI) | 12 week post injection | 4330 score on a scale | Standard Deviation 2038.9 |
| Botulinum Toxin A Then Placebo | Patient-generated Index (PGI) | crossover 12 week follow up | 3333.3 score on a scale | Standard Deviation 763.8 |
| Botulinum Toxin A Then Placebo | Patient-generated Index (PGI) | Baseline | 4250 score on a scale | Standard Deviation 1885.5 |
| Placebo Then Botulinum Toxin A | Patient-generated Index (PGI) | crossover 12 week follow up | 1500 score on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | Patient-generated Index (PGI) | Baseline | 1500 score on a scale | Standard Deviation 1802.8 |
| Placebo Then Botulinum Toxin A | Patient-generated Index (PGI) | 2 week post injection | 1550 score on a scale | Standard Deviation 1789.6 |
| Placebo Then Botulinum Toxin A | Patient-generated Index (PGI) | 4 week post injection | 1825 score on a scale | Standard Deviation 2439.5 |
| Placebo Then Botulinum Toxin A | Patient-generated Index (PGI) | 8 week post injection | 2800 score on a scale | Standard Deviation 2498 |
| Placebo Then Botulinum Toxin A | Patient-generated Index (PGI) | 12 week post injection | 1800 score on a scale | Standard Deviation 2545.6 |
| Placebo Then Botulinum Toxin A | Patient-generated Index (PGI) | crossover 2 week follow up | 3500 score on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | Patient-generated Index (PGI) | crossover 4 week follow up | 3750 score on a scale | Standard Deviation 0 |
| Placebo Then Botulinum Toxin A | Patient-generated Index (PGI) | crossover 8 week follow up | 3000 score on a scale | Standard Deviation 0 |
Secondary
Static Mechanical Allodynia Testing
Mechanical allodynia is a characteristic of evoked pain in subjects with neuropathic pain. Static allodynia to mechanical stimuli will be defined as a sensation of pain evoked by the pressure of the end of a wooden stick. The end of a wooden stick will touch the affected region with enough pressure to indent the skin, for 10 seconds. Afterwards, the subject will be asked to rate the perceived pain on an 11-point NRS.
Time frame: up to 12 weeks post-injection, for a total of 24 weeks from baseline
Population: Data initially collected incorrectly, then data not collected.