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Assessment of Pain in People With Thalassemia (Pain)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00872339
First Posted: March 31, 2009
Last Update Posted: June 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New England Research Institutes
March 30, 2009
March 31, 2009
January 2, 2014
June 5, 2014
June 5, 2014
March 2009
June 2010   (Final data collection date for primary outcome measure)
Prevalence of Pain [ Time Frame: Measured at Month 9 ]
Prevalence of pain in participants with transfusion and non-transfusion dependent thalassemia [ Time Frame: Measured at Month 9 ]
Complete list of historical versions of study NCT00872339 on ClinicalTrials.gov Archive Site
  • Common Sites of Pain [ Time Frame: Measured at Month 9 ]
  • Pain Occurrence by Age [ Time Frame: Measured at Month 9 ]
  • Impact of Pain on Functioning and Well-being [ Time Frame: Measured at Month 9 ]
  • Common sites of pain by age, gender, and diagnosis [ Time Frame: Measured at Month 9 ]
  • Pain severity and influence of age, gender, or diagnosis [ Time Frame: Measured at Month 9 ]
  • Impact of Pain on Functioning and Well-being [ Time Frame: Measured at Month 9 ]
  • Effectiveness of treatment and medication over time [ Time Frame: Measured at Month 9 ]
  • Correlate the Brief Pain Inventory (BPI) and Adolescent Pediatric Pain Tool (APPT) in the adolescent population [ Time Frame: Measured at Month 9 ]
Not Provided
Not Provided
 
Assessment of Pain in People With Thalassemia
Assessment of Pain in People With Thalassemia
Thalassemia is an inherited blood disorder that can result in mild to severe anemia. People with thalassemia often experience pain, but the exact sources and prevalence of pain remain unknown. This study will examine the prevalence and severity of pain in people with thalassemia who are treated with regular blood transfusions and people with thalassemia who are not treated with regular blood transfusions.

Thalassemia is an inherited blood disorder in which the body makes an abnormal form of hemoglobin—the protein in red blood cells that carries oxygen. People with thalassemia often experience fatigue, shortness of breath, and pain. Recent medical advances in treating people with thalassemia who receive regular blood transfusions—a standard procedure that refreshes the healthy red blood supply—have resulted in increased life spans for these people. However, with the extended life spans have come additional issues, including pain. There have been no previous research studies that have examined pain levels in people with thalassemia, and as a result, the sources and prevalence of pain remain unknown. The purpose of this study is to assess the prevalence and severity of pain, common pain sites, and the impact of pain on functioning and well-being in people with thalassemia who receive regular blood transfusions and people with thalassemia who do not receive regular blood transfusions.

This study will enroll people with transfusion-dependant thalassemia and people with non-transfusion-dependant thalassemia. At a baseline study visit, participants will complete a demographic questionnaire and a pain assessment questionnaire. At Months 3, 6, and 9, study researchers will telephone participants to go over the same pain assessment questionnaire again.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Thalassemia patients who receive regular blood transfusions and those who do not receive regular blood transfusions.
Thalassemia
Not Provided
  • transfusion-dependant
    People with transfusion-dependant thalassemia who received at least 8 transfusions in the past year.
  • non-transfusion-dependant
    People with non-transfusion-dependant thalassemia who received no transfusions in the past year.
  • intermittently transfused
    Intermittently transfused patients- individuals who received at least one but fewer than eight transfusions in the last year
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
252
December 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Thalassemia, as documented by clinical diagnosis, including the following:

    1. B-thalassemia (intermedia or major)
    2. Hgb H disease
    3. Hgb H with non-deletional mutations (e.g., Hgb H Constant Spring)
    4. E-B-thalassemia
    5. Homozygous alpha thalassemia
    6. Other thalassemic conditions not explicitly excluded
    7. Thalassemia intermedia due to heterozygous B mutation with an alpha excess
  • Participants can be of any race, ethnicity, and either gender.

Exclusion Criteria:

  • Thalassemia trait (i.e., single recessive B gene mutation, 2 gene alpha mutation) and thalassemia Hgb S, C, or D compound heterozygotes
  • Unwillingness or inability to complete the Brief Pain Inventory (BPI) on a quarterly basis
  • Has had a successful bone marrow transplant
Sexes Eligible for Study: All
12 Years to 90 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00872339
639
U01HL065238 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
New England Research Institutes
New England Research Institutes
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Jeanne Boudreeaux, MD Children's Healthcare of Atlanta
Principal Investigator: Ellis Neufeld, MD Boston Children’s Hospital
Principal Investigator: Alexis Thompson, MD Children's Memorial Hospital of Chicago
Principal Investigator: Brigitta Mueller, MD Baylor College of Medicine at Houston
Study Chair: Dru Foote, RN, NP Children's Hospital and Research Institute of Oakland
Principal Investigator: Patricia Giardina, MD Weill Medical College of Cornell
Principal Investigator: Janet Kwiatkowski, MD Children's Hospital of Philadelphia
Principal Investigator: Nancy Olivieri, MD Toronto General Hospital
New England Research Institutes
January 2014