Trial Outcomes & Findings for Investigating Botulinum Toxin A to Treat Acute Neck/Upper Shoulder Pain Following a New Spinal Cord Injury. (NCT NCT00320281)
NCT ID: NCT00320281
Last Updated: 2020-10-14
Results Overview
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."
COMPLETED
PHASE4
19 participants
6 weeks post-injection
2020-10-14
Participant Flow
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.
Participant milestones
| Measure |
Group 1-Botox A Group
This group received the active drug, botox a injections.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigating Botulinum Toxin A to Treat Acute Neck/Upper Shoulder Pain Following a New Spinal Cord Injury.
Baseline characteristics by cohort
| Measure |
Group 1-Botox A Group
n=10 Participants
This group received the active drug, botox a injections.
|
Group 2-saline Group
n=9 Participants
Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 14.44 • n=5 Participants
|
35.91 years
STANDARD_DEVIATION 11 • n=7 Participants
|
36.15 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post-injectionThe 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."
Outcome measures
| Measure |
Group 1-Botox A Group
n=10 Participants
Those randomized to this treatment group received injections based on treatment plan designed by PI and study physical therapist. Botulism toxin A was diluted in 25 cc of saline for the injections. Multiple injections may have occured during a single clinic visit based on pain/stiffness upon assesment by the study treatment team.
|
Group 2-saline Group
n=9 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.
|
|---|---|---|
|
Numerical Rating Scale-NRS
|
4.50 units on a scale
Interval 2.58 to 6.42
|
3.44 units on a scale
Interval 1.42 to 5.46
|
SECONDARY outcome
Timeframe: 6 months post-injectionInterference 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.
Outcome measures
| Measure |
Group 1-Botox A Group
n=10 Participants
Those randomized to this treatment group received injections based on treatment plan designed by PI and study physical therapist. Botulism toxin A was diluted in 25 cc of saline for the injections. Multiple injections may have occured during a single clinic visit based on pain/stiffness upon assesment by the study treatment team.
|
Group 2-saline Group
n=9 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.
|
|---|---|---|
|
Brief Pain Inventory-Short Form - Interference Score
|
3.19 units on a scale
Interval 1.65 to 4.73
|
1.62 units on a scale
Interval 0.08 to 3.16
|
Adverse Events
Group 1-Botox A Group
Group 2-saline Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place