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Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder

This study has been completed.
Sponsor:
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT00884065
First received: February 9, 2009
Last updated: August 24, 2011
Last verified: August 2011
History of Changes
Results First Received: February 9, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Shoulder Pain
Interventions: Other: Diacutaneous Fibrolysis
Other: Diacutaneous Fibrolysis (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
The study participants were recruited from two public services of primary health care of the Spanish National Health Service, one in Cornellà de Llobregat (Barcelona), the other in Ponteareas (Pontevedra), from June 2007 to January 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intervention Group (Diacutaneous Fibrolysis) The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
Control Group (Placebo) The control group was treated with a single placebo session of Diacutaneous Fibrolysis.

Participant Flow:   Overall Study
    Intervention Group (Diacutaneous Fibrolysis)     Control Group (Placebo)  
STARTED     25     25  
COMPLETED     25     25  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Intervention Group (Diacutaneous Fibrolysis) The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
Control Group (Placebo) The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
Total Total of all reporting groups

Baseline Measures
    Intervention Group (Diacutaneous Fibrolysis)     Control Group (Placebo)     Total  
Number of Participants  
[units: participants]
 		  25     25     50  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     17     15     32  
>=65 years     8     10     18  
Age  
[units: years]
Mean ± Standard Deviation 		  56.76  ± 10.33     60.8  ± 10.12     58.78  ± 10.33  
Gender  
[units: participants]
 		     
Female     16     13     29  
Male     9     12     21  
Region of Enrollment  
[units: participants]
 		     
Spain     25     25     50  
Months of pain  
[units: Months]
Mean ± Standard Deviation 		  14.48  ± 16.21     17.88  ± 27.56     16.18  ± 22.44  



  Outcome Measures
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1.  Primary:   Change in Active Flexion Movement After Intervention Minus Baseline   [ Time Frame: Baseline and the same day (just after intervention) ]
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2.  Primary:   Change in Active Abduction Movement After Intervention Minus Baseline   [ Time Frame: Baseline and the same day (just after intervention) ]
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3.  Primary:   Change in Active extensión Movement After Intervention Minus Baseline   [ Time Frame: Baseline and the same day (just after intervention) ]
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4.  Primary:   Change in Active External Rotation After Intervention Minus Baseline   [ Time Frame: Baseline and the same day (just after intervention) ]
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5.  Primary:   Change in Active Internal Rotation After Intervention Minus Baseline   [ Time Frame: Baseline and the same day (just after intervention) ]
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6.  Secondary:   Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline   [ Time Frame: Baseline and the same day (just after intervention) ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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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.


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
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Results Point of Contact:  
Name/Title: Martín Eusebio Barra López
Organization: Catalan Institut of Health - Servei de Rhb Sant Ildefons
e-mail: martinbarra@gmail.com


Publications:


ClinicalTrials.gov Identifier: NCT00884065     History of Changes
Other Study ID Numbers: Idiap08/187
Study First Received: February 9, 2009
Results First Received: February 9, 2009
Last Updated: August 24, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica