Neuropathic Pain in Jamaicans With Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT04015401|
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
|Condition or disease|
|Sickle Cell Disease Neuropathic Pain|
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 :||Observational|
|Estimated Enrollment :||480 participants|
|Official Title:||Neuropathic Pain in Jamaicans With Sickle Cell Disease|
|Estimated Study Start Date :||July 15, 2019|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||July 1, 2020|
- Prevalence of neuropathic pain among Jamaicans with Sickle cell disease (SCD) [ Time Frame: 1 year ]Determine among a clinic population of persons with SCD the prevalence of chronic and neuropathic pain
- 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
- Effect of sex on neuropathic pain [ Time Frame: 1 year ]Is sex (male or female) correlated with the presence of neuropathic pain in persons with SCD
- Validation of common screening tool, PainDetect, in detection of neuropathic pain in persons with sickle cell disease [ Time Frame: 1 year ]Determine limits of agreement of detecting the presence of neuropathic pain using common screening tools with the gold standard measurement using quantitative sensory testing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015401
|Contact: Zachary Ramsay, MBBSfirstname.lastname@example.org|
|Contact: Rachel Bartlett, RNemail@example.com|
|Caribbean Institute for Health Research||Recruiting|
|Kingston, Jamaica, Kingston 7|
|Contact: Zachary Ramsay, MBBS 8768272471 ext 253 firstname.lastname@example.org|
|Principal Investigator:||Monika Asnani, DM PhD||Caribbean Institute for Health Research|
|Study Director:||Zachary Ramsay, MBBS||Caribbean Institute for Health Research|