Assessment of Pain in People With Thalassemia

C

Carelon Research

Status

Completed

Conditions

Thalassemia

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00872339
U01HL065238 (U.S. NIH Grant/Contract)
639

Details and patient eligibility

About

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.

Full 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.

Enrollment

252 patients

Sex

All

Ages

12 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

252 participants in 3 patient groups

transfusion-dependant
Description:
People with transfusion-dependant thalassemia who received at least 8 transfusions in the past year.
non-transfusion-dependant
Description:
People with non-transfusion-dependant thalassemia who received no transfusions in the past year.
intermittently transfused
Description:
Intermittently transfused patients- individuals who received at least one but fewer than eight transfusions in the last year

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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