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| Name | Class |
|---|---|
| The Craig H. Neilsen Foundation | OTHER |
| Allergan | INDUSTRY |
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As clinicians, it is often a struggle to find effective pain control for a certain subgroup of patients with tetraplegia. These patients often have severe upper back, neck, and shoulder pain, limiting rehabilitation productivity and potential, and always limiting quality of life.
This pain appears to be primarily musculoskeletal. Muscles in the upper back and neck become shortened, rock hard, and extremely tender with even the slightest touch or stretch. Refractory to multiple classes of medications, modalities, and other treatments, patients truly suffer-not only from pain, but from fatigue, sedation, expense, and loss of useful rehabilitation time due to attempted remedies. Unfortunately, this subgroup of patients is not small and the problem is significant, as anyone who specializes in the treatment of spinal cord injury patients will recognize.
In search for another form of treatment, botulinum toxin A (BTXA) may be promising for pain control in that group of patients with tetraplegia whose pain has proven to be refractory to treatment. It did not take long searching the literature to find compelling evidence that BTXA may have another mechanism of action for direct pain control, apart from its well known mechanism for spasticity control. Clinically, it is increasingly being recommended and used for this purpose. In fact, one of the specific indications now recognized by most for BTXA treatment is for myogenic pain due to short, tight, strained muscles-just as we see with our population. Yet, it's application has not been studied in people with tetraplegia. Thus, the genesis of the project and the hope to help our patients evolved.
Study hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Normal saline injections were used for placebo injections. Injections were based on treatment plan determined in clinical setting by study PI and physical therapist. 25 cc syringe was used and amount of saline injected was unit based on muscles to be injected according to the treatment plan. |
|
| Botulinum toxin A | Active Comparator | Botulism toxin A dosage was based on plan developed in clinical setting with study PI and physical therapist. Drug was dosed in 25 cc syringe,diluted with normal saline and injections occured based on treatment plan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin A | Drug | Injection of BTXA into cervical and upper back muscles based on treatment plan prescribed for each participant individually based on muscle soreness and tightness. Injections occured on one single clinic visit.Both the saline and BTXA were dosed in 25 cc syringes and looked the same for the physician performing the injections to ensure both participant and study physician remained blinded. |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale-NRS | The Numerical Rating Scale (NRS) is a numerical scale from 0-10 used to rate pain. Participants were asked to assess the worst pain experienced in the past 5 days and rate it on a numerical scale from 0-10, with 10 being the "worst possible pain" they have experienced and 0 being "no pain." | 6 weeks post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory-Short Form - Interference Score | Interference in daily activities was measured with the Brief Pain Inventory (BPI) Interference Score. Participants rated the extent to which pain interfered with their participation in six general activities during the past week, using a scale of 0 (does not interfere) to 10 (completely interferes). Note that for the purposes of this study, the question regarding walking was removed from the original scale which has seven items). Mean score across the 6 items was calculated (range could be 0 - 10) with higher score indicating more pain interference. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Maerz, MD | Craig Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Craig Hospital | Englewood | Colorado | 80113 | United States |
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Participants that met eligibility criteria were enrolled from April 2006 through August 2008. All participants were enrolled while undergoing inpatient rehabilitation at Craig Hospital. 19 individuals were enrolled and randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1-Botox A Group | This group received the active drug, botox a injections. |
| FG001 | Group 2-saline Group | Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1-Botox A Group | This group received the active drug, botox a injections. |
| BG001 | Group 2-saline Group | Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received |
| 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 | Numerical Rating Scale-NRS | The Numerical Rating Scale (NRS) is a numerical scale from 0-10 used to rate pain. Participants were asked to assess the worst pain experienced in the past 5 days and rate it on a numerical scale from 0-10, with 10 being the "worst possible pain" they have experienced and 0 being "no pain." | Posted | Mean | 95% Confidence Interval | units on a scale | 6 weeks post-injection |
|
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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 | Group 1-Botox A Group | This group received the active drug, botox a injections. |
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Study outcome measures modified to reflect available study results. AE's monitored daily; specific data is not available (study completed >10yrs ago). Investigator summary indicates no SAE's/AE's related to study intervention (treatment or sham).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gary Maerz | Craig Hospital | 303-789-8220 | adannels@craighospital.org |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010146 | Pain |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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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 | Other | Injection of normal saline into cervical and upper back muscles was also based on treatment plan prescribed for each participant individually based on muscle soreness and tightness. Injections occured on one single clinic visit. Both the saline and BTXA were dosed in 25 cc syringes and looked the same for the physician performing the injections to ensure both participant and study physician remained blinded. |
|
|
| 6 months post-injection |
| 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 |
|
Those randomized to this treatment group received injections based on treatment plan devised by study PI and study physical therapist. 25 cc of saline were used for these injections. Multiple injections may have occured during a single clinic visit based on pain/stiffness upon assesment by the study treatment team. |
|
|
|
| Secondary | Brief Pain Inventory-Short Form - Interference Score | Interference in daily activities was measured with the Brief Pain Inventory (BPI) Interference Score. Participants rated the extent to which pain interfered with their participation in six general activities during the past week, using a scale of 0 (does not interfere) to 10 (completely interferes). Note that for the purposes of this study, the question regarding walking was removed from the original scale which has seven items). Mean score across the 6 items was calculated (range could be 0 - 10) with higher score indicating more pain interference. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months post-injection |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Group 2-saline Group | Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received | 0 | 9 | 0 | 9 |
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| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |