Steroid Injection for Sickle Cell Arthropathy Pain Therapy

Completed

• Conditions: Sickle Cell Abnormality; Sickle Cell Disease

• Registration Number: NCT05983055
• Lead Sponsor: Salem Anaesthesia 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.

Study Timeline

• Study Start: 2018-01-30
• Study First Submitted: 2023-08-01
• Study First Submitted QC: 2023-08-01
• Study First Posted: 2023-08-09
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numeric pain score, objective measurement using validated Numeric Pain Rating scale	12 weeks	Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain

Secondary Outcome Measures

Name	Time	Method
Sleep quality score, objective measurement using validated Likert sleep scale	12 weeks	Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep

Trial Locations

Locations (1)

Salem Anaesthesia Pain Clinic; 🇨🇦 Surrey, British Columbia, Canada