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Effectiveness of Oral Prednisone in Improving Physical Functioning and Decreasing Pain in People With Sciatica (ACT FAST)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00668434
First received: April 25, 2008
Last updated: April 9, 2015
Last verified: April 2015
Results First Received: October 20, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Sciatica
Interventions: Drug: Prednisone
Drug: Placebo

  Participant Flow
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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
Prednisone

Participants will receive a 15-day tapering course of prednisone capsules.

Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days.

Placebo

Participants will receive a 15-day course of placebo capsules.

Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine.


Participant Flow for 2 periods

Period 1:   Primary Outcome Time Point (3 Weeks)
    Prednisone     Placebo  
STARTED     181 [1]   88 [1]
COMPLETED     179     88  
NOT COMPLETED     2     0  
[1] Baseline

Period 2:   Secondary Outcome Time Point (52 Weeks)
    Prednisone     Placebo  
STARTED     179 [1]   88 [1]
COMPLETED     157     77  
NOT COMPLETED     22     11  
[1] Baseline



  Baseline Characteristics
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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
Prednisone

Participants will receive a 15-day tapering course of prednisone capsules.

Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days.

Placebo

Participants will receive a 15-day course of placebo capsules.

Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine.

Total Total of all reporting groups

Baseline Measures
    Prednisone     Placebo     Total  
Number of Participants  
[units: participants]
  181     88     269  
Age  
[units: years]
Mean (Standard Deviation)
  45.6  (11.8)     46.7  (12.6)     46.0  (12.1)  
Gender  
[units: participants]
     
Female     83     37     120  
Male     98     51     149  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     4     5  
Asian     24     8     32  
Native Hawaiian or Other Pacific Islander     2     0     2  
Black or African American     3     3     6  
White     129     50     179  
More than one race     10     9     19  
Unknown or Not Reported     12     14     26  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     34     28     62  
Not Hispanic or Latino     147     60     207  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     181     88     269  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Oswestry Disability Index, v2   [ Time Frame: Baseline, Week 3 follow-up ]

2.  Secondary:   Pain Numerical Rating Scale   [ Time Frame: Baseline, Week 3 follow-up ]

3.  Secondary:   Oswestry Disability Index, v2   [ Time Frame: Baseline, Week 52 follow-up ]

4.  Secondary:   Pain Numerical Rating Scale   [ Time Frame: Baseline, Week 52 follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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. Andrew Avins
Organization: Kaiser Permanente, Northern California
phone: 510-891-3557
e-mail: andy.l.avins@kp.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00668434     History of Changes
Other Study ID Numbers: R01AR053960 ( US NIH Grant/Contract Award Number )
Study First Received: April 25, 2008
Results First Received: October 20, 2014
Last Updated: April 9, 2015
Health Authority: United States: Federal Government