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Pathophysiology of Post Amputation Pain (PPAP)

This study has been completed.
Sponsor:
Collaborators:
United States Department of Defense
Northwestern University
Information provided by (Responsible Party):
Dr. Norman Harden, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT01632709
First received: June 11, 2012
Last updated: July 20, 2015
Last verified: July 2015
Results First Received: June 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Amputation Stumps
Neuroma
Interventions: Drug: Bupivacaine
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
Subjects were not assigned to an arm until Visit 2 (randomization).

Reporting Groups
  Description
Sympathetic Nerve Block of Bupivacaine No text entered.
Dry Needling at Sympathetic Ganglion No text entered.
Neuroma Injection of Bupivacaine No text entered.
Dry Needling at the Neuroma No text entered.

Participant Flow:   Overall Study
    Sympathetic Nerve Block of Bupivacaine     Dry Needling at Sympathetic Ganglion     Neuroma Injection of Bupivacaine     Dry Needling at the Neuroma  
STARTED     4     3     5     4  
Completed Visit 2 (Received Injection)     4     2     5     3  
COMPLETED     2     2     5     3  
NOT COMPLETED     2     1     0     1  



  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
Sympathetic Nerve Block of Bupivacaine No text entered.
Dry Needling at Sympathetic Ganglion No text entered.
Neuroma Injection of Bupivacaine No text entered.
Dry Needling at the Neuroma No text entered.
Total Total of all reporting groups

Baseline Measures
    Sympathetic Nerve Block of Bupivacaine     Dry Needling at Sympathetic Ganglion     Neuroma Injection of Bupivacaine     Dry Needling at the Neuroma     Total  
Number of Participants  
[units: participants]
  4     2     5     3     14  
Age  
[units: years]
Mean (Standard Deviation)
  67.8  (11.9)     55  (8.5)     50.4  (9.4)     43.3  (7)     53.4  (13.8)  
Gender  
[units: participants]
         
Female     0     1     1     3     5  
Male     4     1     4     0     9  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     0     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     1     2     2     2     7  
White     2     0     2     1     5  
More than one race     0     0     1     0     1  
Unknown or Not Reported     1     0     0     0     1  



  Outcome Measures
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1.  Primary:   Change in Pain   [ Time Frame: Pain rating before and at 15 minutes and 1 hour post injection ]

2.  Secondary:   Change in Perceived Disability (PDI)   [ Time Frame: PDI collected pre injection and 1 week post injection ]

3.  Secondary:   Change in Perceived Anxiety (PASS)   [ Time Frame: PASS collected pre injection and 1 week post injection ]

4.  Secondary:   Change in Depression (CES-D 10)   [ Time Frame: CES-D 10 collected pre injection and 1 week post injection ]

5.  Secondary:   Pain Visual Analogue Scale (VAS)   [ Time Frame: VAS collected pre injection and 1 week post injection ]


  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: Center for Pain Studies
Organization: Rehabilitation Institute of Chicago
phone: 312.238.5654
e-mail: centerforpainstudies@ric.org



Responsible Party: Dr. Norman Harden, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT01632709     History of Changes
Other Study ID Numbers: DOD_PAP 12
Study First Received: June 11, 2012
Results First Received: June 1, 2015
Last Updated: July 20, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government