NCT00872339

Assessment of Pain in People With Thalassemia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 252 (actual)
• Sponsor: Carelon Research · Academic / Other
• Sex: All
• Age: 12 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Thalassemia

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-06-01
• Completion: 2010-12-01
• First posted: 2009-03-31
• Last updated: 2014-06-05
• Results posted: 2014-06-05

Locations

8 sites across 2 countries: United States, Canada