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Assessment of Pain in People With Thalassemia (Pain)

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ClinicalTrials.gov Identifier: NCT00872339
Recruitment Status : Completed
First Posted : March 31, 2009
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
HealthCore-NERI

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Thalassemia
Enrollment 252
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Transfusion-dependant Intermittently Transfused Non-transfusion-dependant
Hide Arm/Group Description People with transfusion-dependant thalassemia. Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year People with non-transfusion-dependant thalassemia.
Period Title: Overall Study
Started 201 14 37
Completed 201 14 37
Not Completed 0 0 0
Arm/Group Title Transfusion-dependant Intermittently Transfused Non-transfusion-dependant Total
Hide Arm/Group Description People with transfusion-dependant thalassemia. Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year People with non-transfusion-dependant thalassemia. Total of all reporting groups
Overall Number of Baseline Participants 201 14 37 252
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 201 participants 14 participants 37 participants 252 participants
28.2  (10.4) 35.8  (14.4) 29.5  (16.2) 28.8  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 14 participants 37 participants 252 participants
Female
117
  58.2%
6
  42.9%
14
  37.8%
137
  54.4%
Male
84
  41.8%
8
  57.1%
23
  62.2%
115
  45.6%
1.Primary Outcome
Title Prevalence of Pain
Hide Description [Not Specified]
Time Frame Measured at Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transfusion-dependant Intermittently Transfused Non-transfusion-dependant
Hide Arm/Group Description:
People with transfusion-dependant thalassemia.
Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
People with non-transfusion-dependant thalassemia.
Overall Number of Participants Analyzed 201 14 37
Measure Type: Number
Unit of Measure: participants
75 7 11
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transfusion-dependant, Intermittently Transfused, Non-transfusion-dependant
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Common Sites of Pain
Hide Description [Not Specified]
Time Frame Measured at Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects Combined
Hide Arm/Group Description:
Subjects with pain in the last 7 days were combined into one group.
Overall Number of Participants Analyzed 93
Measure Type: Number
Unit of Measure: participants
Lower back 76
Either leg 52
Head 45
Midback 44
Either hip 36
Upper back 36
Either arm 29
Abdomen 26
Chest 25
3.Secondary Outcome
Title Pain Occurrence by Age
Hide Description [Not Specified]
Time Frame Measured at Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects Combined
Hide Arm/Group Description:
Subjects were combined into one group.
Overall Number of Participants Analyzed 252
Measure Type: Number
Unit of Measure: participants
12-17 yo (n=50) 4
18-24 (n=56) 19
25-34 (n=61) 22
35-44 (n=61) 34
45-71 (n=24) 14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Subjects Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Impact of Pain on Functioning and Well-being
Hide Description [Not Specified]
Time Frame Measured at Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects Combined
Hide Arm/Group Description:
Subjects with pain in the last 7 days were combined into one group.
Overall Number of Participants Analyzed 93
Measure Type: Number
Unit of Measure: participants
Mood 83
Normal work 76
General activities 74
Sleep 74
Walking 73
Enjoyment of life 69
Interpersonal relations 57
Time Frame Adverse events were not collected for this study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adverse Events Were Not Collected
Hide Arm/Group Description Adverse events were not collected for this study.
All-Cause Mortality
Adverse Events Were Not Collected
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Adverse Events Were Not Collected
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adverse Events Were Not Collected
Affected / at Risk (%)
Total   0/0 
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Felicia Trachtenberg
Organization: New England Research Institutes
Phone: 6179723120
EMail: ftrachtenberg@neriscience.com
Publications of Results:
Haines D, Martin M, Carson S, Oliveros O, Green S, Coates T, Eile J, Schilling L, Dinu B, Mendoza T, Gerstenberger E, Trachtenberg F, Vichinsky E; Thalassemia Clinical Research Network. Pain in thalassaemia: the effects of age on pain frequency and severity. Br J Haematol. 2013 Mar;160(5):680-7. doi: 10.1111/bjh.12177. Epub 2012 Dec 30.
Layout table for additonal information
Responsible Party: HealthCore-NERI
ClinicalTrials.gov Identifier: NCT00872339    
Other Study ID Numbers: 639
U01HL065238 ( U.S. NIH Grant/Contract )
First Submitted: March 30, 2009
First Posted: March 31, 2009
Results First Submitted: January 2, 2014
Results First Posted: June 5, 2014
Last Update Posted: June 5, 2014