- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04015401
Neuropathic Pain in Jamaicans With Sickle Cell Disease
Study Overview
Status
Conditions
Detailed Description
All study participants will complete all the questionnaires provided, specifically the Adult Sickle Cell Quality of Life Measurement Information (ASCQ-Me), Leeds Assessment of Neuropathic Symptoms and Signs (LANSS), PainDETECT and Douleur Neuropathique 4 (DN4). All study participants will also have qualitative sensory testing and laboratory investigations done. Nerve conduction studies will only be done on a randomly selected 20 percent sub-study sample.
Laboratory investigations include sample of blood (~ 10 mls) will also be collected for the participants and analysed for Haemoglobin (steady state), white blood cells, and lactate dehydrogenase, percent reticulocytes. These are common markers of disease severity in SCD. Disease severity is one of the variables which will be used in the epidemiological description of the study population as well as in the statistical analysis of the data.
The Q-Sense will be used to conduct quantitative sensory tests. This allows specific degrees of heat/cold stimulation to assess sensation and pain thresholds to be applied and patients indicate at which degree they detect the stimuli and furthermore when it becomes painful, at each site. The results are then compared to known controls. Hypersensitivity and allodynia to thermal stimuli is considered diagnostic for neuropathic pain. The tests are considered safe in sickle cell patients and when tested have not resulted in any crisis. Patients may experience mild pain after the test, and therefore will be asked to take their regular analgesics immediately following the test.
Nerve conduction studies (NCS): A subset of participants identified with chronic or presumed neuropathic pain will, in addition to QST, receive a standard neurophysiological evaluation by nerve conduction studies to determine the presence/absence of a large fibre neuropathy, whether a focal mononeuropathy or diffuse polyneuropathy. Polyneuropathies will be characterized by process as either axonal or demyelinating, and by pattern as sensory, motor or sensorimotor, with comparisons to findings on QST.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Zachary Ramsay, MBBS
- Phone Number: 8769272471
- Email: zachary.ramsay@uwimona.edu.jm
Study Contact Backup
- Name: Rachel Bartlett, RN
- Phone Number: 8769272471
- Email: bartlettrachel9223@gmail.com
Study Locations
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Kingston, Jamaica, Kingston 7
- Caribbean Institute for Health Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 14 and older, of any sex and genotype
- Informed consent/parental consent with child assent available
- In well state at time of study
Exclusion Criteria:
- Prior cerebrovascular accidents
- Acute illness at time of recruitment
- Current Pregnancy
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of neuropathic pain among Jamaicans with Sickle cell disease (SCD)
Time Frame: 1 year
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Determine among a clinic population of persons with SCD the prevalence of chronic and neuropathic pain
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of age on neuropathic pain
Time Frame: 1 year
|
Is age ( in years) correlated with the presence of neuropathic pain in persons with SCD
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1 year
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Effect of sex on neuropathic pain
Time Frame: 1 year
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Is sex (male or female) correlated with the presence of neuropathic pain in persons with SCD
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1 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validation of common screening tool, PainDetect, in detection of neuropathic pain in persons with sickle cell disease
Time Frame: 1 year
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Determine limits of agreement of detecting the presence of neuropathic pain using common screening tools with the gold standard measurement using quantitative sensory testing
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1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Monika Asnani, DM PhD, Caribbean Institute for Health Research
- Study Director: Zachary Ramsay, MBBS, Caribbean Institute for Health Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NP001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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