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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Group 1-Botox A Group   Group 2-saline Group
STARTED   10   9 
COMPLETED   10   9 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   Group 1-Botox A Group   Group 2-saline Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   9   19 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   10   9   19 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.4  (14.44)   35.91  (11)   36.15  (12) 
Gender 
[Units: Participants]
     
Female   7   6   13 
Male   3   3   6 
Region of Enrollment 
[Units: Participants]
     
United States   10   9   19 


  Outcome Measures

1.  Primary:   Numerical Rating Scale-NRS   [ Time Frame: 6 weeks post-injection ]

2.  Primary:   Brief Pain Inventory-SF   [ Time Frame: 2 weeks, 6 weeks, and 6 months post-injection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Primary:   Short-Form McGill Pain Questionnaire   [ Time Frame: 2 weeks, 6 weeks, and 6 months post-injection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Modified Leeds Neuropathic Symptoms and Signs Scale   [ Time Frame: 2 weeks, 6 weeks, and 6 months post-injection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Beck Depression Inventory   [ Time Frame: 2 weeks and 6 weeks post-injection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Cervical Range of Motion Measurements   [ Time Frame: 2 weeks and 6 weeks post-injection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Patient Global Outcome Ratings   [ Time Frame: 2 weeks, 6 weeks, and 6 months post-injection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Respiratory Function Measures   [ Time Frame: 2 weeks and 6 weeks post-injection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Rehabilitation Interference Scale (RIS)   [ Time Frame: 2 weeks and 6 weeks post-injection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: adannels@craighospital.org



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