N/A
N=252
Assessment of Pain in People With Thalassemia
Thalassemia
Bottom Line
View on ClinicalTrials.gov: NCT00872339 ↗Enrolled (actual)
252
Serious AEs
—
Results posted
Jun 2014
Primary outcome: Primary: Prevalence of Pain — 75; 7; 11 participants — p=0.45
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Carelon Research
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevalence of Pain |
75; 7; 11 | 0.45 |
| SECONDARY Common Sites of Pain |
76; 52; 45; 44; 36; 36 | — |
| SECONDARY Pain Occurrence by Age |
4; 19; 22; 34; 14 | <.001 sig |
| SECONDARY Impact of Pain on Functioning and Well-being |
83; 76; 74; 74; 73; 69 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Thalassemia, as documented by clinical diagnosis, including the following:
- B-thalassemia (intermedia or major)
- Hgb H disease
- Hgb H with non-deletional mutations (e.g., Hgb H Constant Spring)
- E-B-thalassemia
- Homozygous alpha thalassemia
- Other thalassemic conditions not explicitly excluded
- 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
Data sourced from ClinicalTrials.gov (NCT00872339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.