Pain, Spinal Cord Injury
Conditions
Keywords
Botox
Brief summary
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: * In addition to traditional treatments used for pain control, injection of BTXA into cervical and upper back muscles will effectively reduce cervical/shoulder pain severity reported by individuals with cervical spinal cord injuries, regardless of the etiology of pain. * Pain reduction secondary to the use of BTXA will be associated with a decrease in total analgesic medication use among SCI patients during acute inpatient rehabilitation. * BTXA to treat cervical/shoulder pain will increase active participation in the rehabilitation program for individuals with tetraplegia during inpatient rehabilitation.
Interventions
DRUGbotulinum toxin A
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.
OTHERplacebo
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.
Sponsors
The Craig H. Neilsen Foundation
Allergan
Craig Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inpatient at Craig Hospital for initial rehabilitation following a traumatic spinal cord injury. * Cervical Injury at C4-C8 * ASIA classification score of A,B,or C * May still be in halo immobilization device and range of motion scores will therefore not be collected * Report at least a 6/10 on the VAS for pain in the previous 24 hours prior to randomization * Orthopedically stable * Approval of attending physician * Standard of care management with oral analgesic agents has not resulted in pain symptom resolution * May not be enrolled in other clinical trial
Exclusion criteria
* Pregnant * Concurrent use of aminoglycoside antibiotics at the time of injection * Diagnosis of myasthenia gravis or Eaton-Lambert Syndrome * Known sensitivities to toxins * Severe bradycardia (HR\<50 bpm) or hypotension (systolic blood pressure of \<80 mmHg) * Deep vein thrombosis treatment doses of anticoagulants or coumadin * History of recent dysphagia * Ventilator dependent * Unstable cervical fracture or not surgically stabilized
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale-NRS | 6 weeks post-injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory-Short Form - Interference Score | 6 months post-injection | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Group 1-Botox A Group This group received the active drug, botox a injections. | 10 |
| 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 | 9 |
| Total | 19 |
Baseline characteristics
| Characteristic | Group 2-saline Group | Group 1-Botox A Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 10 Participants | 19 Participants |
| Age, Continuous | 35.91 years STANDARD_DEVIATION 11 | 36.4 years STANDARD_DEVIATION 14.44 | 36.15 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 9 participants | 10 participants | 19 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 |
Outcome results
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.
Time frame: 6 weeks post-injection
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1-Botox A Group | Numerical Rating Scale-NRS | 4.50 units on a scale |
| Group 2-saline Group | Numerical Rating Scale-NRS | 3.44 units on a scale |
p-value: 0.432ANCOVA
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.
Time frame: 6 months post-injection
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1-Botox A Group | Brief Pain Inventory-Short Form - Interference Score | 3.19 units on a scale |
| Group 2-saline Group | Brief Pain Inventory-Short Form - Interference Score | 1.62 units on a scale |