Assessment of Pain in People With Thalassemia

Thalassemia Clinical Trial

— Pain  

Official title:

Assessment of Pain in People With Thalassemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872339
• Other study ID #: 639
• Secondary ID: U01HL065238
• Status: Completed
• Phase: N/A
• First received: March 30, 2009
• Last updated: May 27, 2014
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2014
• Source: New England Research Institutes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thalassemia

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Children's Hospital of Boston	Boston	Massachusetts
United States	Children's Memorial Hospital of Chicago	Chicago	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	Weill Medical College	New York	New York
United States	Children's Hospital and Research Institute at Oakland	Oakland	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
New England Research Institutes	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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 severi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Pain		Measured at Month 9	No
Secondary	Common Sites of Pain		Measured at Month 9	No
Secondary	Pain Occurrence by Age		Measured at Month 9	No
Secondary	Impact of Pain on Functioning and Well-being		Measured at Month 9	No