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Investigating Botulinum Toxin A to Treat Acute Neck/Upper Shoulder Pain Following a New Spinal Cord Injury.

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ClinicalTrials.gov Identifier: NCT00320281
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : July 29, 2013
Last Update Posted : July 29, 2013
Sponsor:
Collaborators:
The Craig H. Neilsen Foundation
Allergan
Information provided by (Responsible Party):
Cynthia Harrison-Felix, PhD, Craig Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Spinal Cord Injury
Pain
Interventions Drug: botulinum toxin A
Other: placebo
Enrollment 19
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.
Pre-assignment Details  
Arm/Group Title Group 1-Botox A Group Group 2-saline Group
Hide Arm/Group Description This group received the active drug, botox a injections. Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
Period Title: Overall Study
Started 10 9
Completed 10 9
Not Completed 0 0
Arm/Group Title Group 1-Botox A Group Group 2-saline Group Total
Hide Arm/Group Description This group received the active drug, botox a injections. 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 of all reporting groups
Overall Number of Baseline Participants 10 9 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
9
 100.0%
19
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 9 participants 19 participants
36.4  (14.44) 35.91  (11) 36.15  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
Female
7
  70.0%
6
  66.7%
13
  68.4%
Male
3
  30.0%
3
  33.3%
6
  31.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 9 participants 19 participants
10 9 19
1.Primary Outcome
Title Numerical Rating Scale-NRS
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1-Botox A Group Group 2-saline Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 10 9
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
4.50
(2.58 to 6.42)
3.44
(1.42 to 5.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1-Botox A Group, Group 2-saline Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.432
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Brief Pain Inventory-SF
Hide Description [Not Specified]
Time Frame 2 weeks, 6 weeks, and 6 months post-injection
Outcome Measure Data Not Reported
3.Primary Outcome
Title Short-Form McGill Pain Questionnaire
Hide Description [Not Specified]
Time Frame 2 weeks, 6 weeks, and 6 months post-injection
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Modified Leeds Neuropathic Symptoms and Signs Scale
Hide Description [Not Specified]
Time Frame 2 weeks, 6 weeks, and 6 months post-injection
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Beck Depression Inventory
Hide Description [Not Specified]
Time Frame 2 weeks and 6 weeks post-injection
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Cervical Range of Motion Measurements
Hide Description [Not Specified]
Time Frame 2 weeks and 6 weeks post-injection
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Patient Global Outcome Ratings
Hide Description [Not Specified]
Time Frame 2 weeks, 6 weeks, and 6 months post-injection
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Respiratory Function Measures
Hide Description [Not Specified]
Time Frame 2 weeks and 6 weeks post-injection
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Rehabilitation Interference Scale (RIS)
Hide Description [Not Specified]
Time Frame 2 weeks and 6 weeks post-injection
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1-Botox A Group Group 2-saline Group
Hide Arm/Group Description This group received the active drug, botox a injections. Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
All-Cause Mortality
Group 1-Botox A Group Group 2-saline Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1-Botox A Group Group 2-saline Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1-Botox A Group Group 2-saline Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/9 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Gary Maerz
Organization: Craig Hospital
Phone: 303-789-8220
Responsible Party: Cynthia Harrison-Felix, PhD, Craig Hospital
ClinicalTrials.gov Identifier: NCT00320281     History of Changes
Other Study ID Numbers: 2691
First Submitted: April 28, 2006
First Posted: May 3, 2006
Results First Submitted: March 1, 2013
Results First Posted: July 29, 2013
Last Update Posted: July 29, 2013