Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320281
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2006-04-28
Brief Title:
Investigating Botulinum Toxin A to Treat Acute NeckUpper Shoulder Pain Following a New Spinal Cord Injury
Sponsor:
Craig Hospital
Organization:
Craig Hospital
Study Overview
Official Title:
Botulinum Toxin A for the Treatment of CervicalShoulder Pain Following Acute Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 its 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 cervicalshoulder 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 cervicalshoulder pain will increase active participation in the rehabilitation program for individuals with tetraplegia during inpatient rehabilitation
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 its 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 cervicalshoulder 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 cervicalshoulder pain will increase active participation in the rehabilitation program for individuals with tetraplegia during inpatient rehabilitation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None