Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04015401 |
| Other study ID # |
NP001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 15, 2019 |
| Est. completion date |
July 1, 2020 |
Study information
| Verified date |
April 2023 |
| Source |
The University of The West Indies |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Pain is the most common component of the morbidity seen in sickle cell disease (SCD), and may
be acute or chronic. It is most commonly acute and a result of the hallmark vaso-occlusive
episodes of the disease. Many patients however suffer from chronic pain - defined as pain
lasting over three months- with neuropathic pain being a component of chronic pain.
Neuropathic pain significantly contributes to the chronicity and morbidity of pain in SCD
patients, and is an inadequately managed complication. There is a paucity of literature
covering this area, and it has never been examined in the Jamaican population. The main
objective of this study is to determine the epidemiology of pain among Jamaicans with SCD,
and determine the prevalence of chronic and neuropathic pain among these patients. A second
objective is to validate, using gold-standard measures, screening tools to determine
neuropathic pain among the study population. This cross-sectional study will investigate the
prevalence of neuropathic pain and complications in a sample of persons with SCD in Jamaica
aged 14 years and older, with a validation sub-study to be conducted on a random 20 percent
of the sample. With improved diagnosis of neuropathic pain, clinicians may potentially
improve the management of pain in SCD, as clinicians should be able to direct our treatment
toward medications and non-pharmacological methods of pain relief that are more specific for
neuropathic pain. All data will be de-identified and maintained in a secure database, with
access limited to key personnel. There is very minimal risk to participants.
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.
