NCT05983055

Brief Summary

Sickle cell disease (SCD) is associated with arthropathy. Arthropathy may require periarticular corticosteroid injection therapy. This observational study examines efficacy, and safety of steroid injections in SCD patients. Data collection includes patient's gender, age, race, smoking history, alcohol intake, analgesic use, pain score, sleep quality, limb joint injections, post-injection analgesia, and post-injection complication. Pain is measured using numeric pain scale. Sleep quality is measured using Likert scale.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2018

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

6.2 years

First QC Date

August 1, 2023

Last Update Submit

January 23, 2025

Conditions

Keywords

Sickle cell

Outcome Measures

Primary Outcomes (1)

  • Numeric pain score, objective measurement using validated Numeric Pain Rating scale

    Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain

    12 weeks

Secondary Outcomes (1)

  • Sleep quality score, objective measurement using validated Likert sleep scale

    12 weeks

Interventions

Periarticular dexamethasone injection

Also known as: Dexamethasone injection

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A cohort of consecutive adult patients who underwent pain management at a pain clinic

You may qualify if:

  • adult chronic pain patients
  • sickle cell disease arthropathy
  • periarticular steroid injection therapy
  • regular sleep diary
  • regular pain diary
  • informed consent for therapy and diary review

You may not qualify if:

  • pediatric patients
  • patient without sickle cell disease arthropathy
  • patient without periarticular steroid injection
  • irregular sleep diary
  • irregular pain diary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, V3S 7J1, Canada

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

DexamethasoneCalcium Dobesilate

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Olumuyiwa Bamgbade, MD,FRCPC

    Salem Anaesthesia Pain Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 9, 2023

Study Start

January 30, 2018

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations