Neuropathic Pain in Jamaicans With Sickle Cell Disease

NCT04015401 | Completed

• 1 other identifier: NP001
• Study Type: observational
• Target: 257
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sickle Cell Disease; Neuropathic Pain

Keywords

Quantitative sensory testing; Jamaica

Outcome Measures

Primary Outcomes (1)

• Prevalence of neuropathic pain among Jamaicans with Sickle cell disease (SCD)

  Determine among a clinic population of persons with SCD the prevalence of chronic and neuropathic pain

  1 year

Secondary Outcomes (2)

• Effect of age on neuropathic pain

  1 year

• Effect of sex on neuropathic pain

  1 year

Other Outcomes (1)

• Validation of common screening tool, PainDetect, in detection of neuropathic pain in persons with sickle cell disease

  1 year

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Using the Sickle Cell Unit (SCU) of the University of the West Indies patient management system, a computer generated random selection of the sample will be carried out from a sampling frame of all patients aged 14 years and older who are coded as 'alive' upon last visit, and who have had at least one visit to the SCU in the last 2 years. The recruitment of participants to satisfy the sample size of 528 participants will be stratified according to five age-sex categories i.e. male and female 14 - 24; 25 - 34; 35 - 44; 45 - 54; 55 + years old. Selected participants will be recruited by phone to attend a clinic appointment where informed consent will be ascertained.

You may qualify if:

• 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

You may not qualify if:

• Prior cerebrovascular accidents
• Acute illness at time of recruitment
• Current Pregnancy

Sponsors & Collaborators

• The University of The West Indies: lead
• Avicanna Inc: collaborator

Study Sites (1)

Caribbean Institute for Health Research

Kingston, Kingston 7, Jamaica

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Neuralgia

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Monika Asnani, DM PhD

  Caribbean Institute for Health Research

  PRINCIPAL INVESTIGATOR

• Zachary Ramsay, MBBS

  Caribbean Institute for Health Research

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 11, 2019
• Study Start: July 15, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

JA (1)