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Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial

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ClinicalTrials.gov Identifier: NCT00790270
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : November 21, 2012
Last Update Posted : November 21, 2012
Sponsor:
Information provided by:
Stony Brook University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cervical Strain
Interventions: Drug: Cyclobenzaprine
Drug: Ibuprofen
Drug: Ibuprofen plus Cyclobenzaprine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Cyclobenzaprine No text entered.
Ibuprofen No text entered.
Ibuprophen Plus Cyclobenzaprine No text entered.

Participant Flow:   Overall Study
    Cyclobenzaprine   Ibuprofen   Ibuprophen Plus Cyclobenzaprine
STARTED   21   20   20 
COMPLETED   21   20   20 
NOT COMPLETED   0   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
Cyclobenzaprine No text entered.
Ibuprofen No text entered.
Ibuprophen Plus Cyclobenzaprine No text entered.
Total Total of all reporting groups

Baseline Measures
   Cyclobenzaprine   Ibuprofen   Ibuprophen Plus Cyclobenzaprine   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   20   20   61 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   21   20   20   61 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 36  (13)   32  (10)   32  (10)   33  (13) 
Gender 
[Units: Participants]
       
Female   14   11   9   34 
Male   7   9   11   27 
Region of Enrollment 
[Units: Participants]
       
United States   21   20   20   61 


  Outcome Measures

1.  Primary:   Use of Rescue Medications   [ Time Frame: 24 hours ]

2.  Secondary:   Resumption of Work or School   [ Time Frame: next day ]

3.  Primary:   Pain   [ Time Frame: Daily for 1 week ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Time to Resumption of Work   [ Time Frame: 1 week ]
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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Adam Singer
Organization: Stony Brook U
phone: 631 444 7856
e-mail: adam.singer@stonybrook.edu



Responsible Party: Adam Singer, MD, Stony Brook University
ClinicalTrials.gov Identifier: NCT00790270     History of Changes
Other Study ID Numbers: SB2003-1234
First Submitted: November 12, 2008
First Posted: November 13, 2008
Results First Submitted: October 19, 2009
Results First Posted: November 21, 2012
Last Update Posted: November 21, 2012