Clinical trial NCT05983055: Steroid Injection for Sickle Cell Arthropathy Pain Therapy
Official title: Suitability of Periarticular Steroid Injections for Sickle Cell Arthropathy Pain Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Sickle Cell Abnormality
Keywords: Sickle cell
Lead sponsor: Salem Anaesthesia Pain Clinic
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of consecutive adult patients who underwent pain management at a pain clinic

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.

Detailed description: Sickle cell disease (SCD) is associated with arthropathy. Arthropathy causes pain which may require periarticular corticosteroid injection therapy. There is inadequate data about the suitability of steroid therapy in SCD patients. This prospective observational study examines the efficacy, and safety of periarticular steroid injections in SCD patients.

This is a cohort study of adult patients undergoing pain management at a pain clinic in Canada. Data collection includes patient's gender, age, race, smoking history, alcohol intake, analgesic usage, numeric pain score, sleep quality score, limb joint injections, post-injection analgesia, and post-injection complication. Pain is measured using numeric pain rating scale. Sleep quality is measured using the Likert Sleep scale. A change in the pain or sleep scores by 2-points is considered significant. Data are analyzed with IBM® SPSS® Statistics 25; using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value \<0.05 is considered significant.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Numeric pain score, objective measurement using validated Numeric Pain Rating scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Sleep quality score, objective measurement using validated Likert sleep scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Salem Anaesthesia Pain Clinic
state: British Columbia
Study officials:
affiliation: Salem Anaesthesia Pain Clinic
name: Olumuyiwa Bamgbade, MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References: