Steroid Injection for Sickle Cell Arthropathy Pain Therapy

Sickle Cell Disease Clinical Trial

Official title:

Suitability of Periarticular Steroid Injections for Sickle Cell Arthropathy Pain Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05983055
• Other study ID #: SalemAn2018 SCD arthro injectn
• Status: Completed
• Start date: January 30, 2018
• Est. completion date: March 31, 2023

Study information

• Verified date: August 2023
• Source: Salem Anaesthesia Pain Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Joint Diseases
• Sickle Cell Disease

Intervention

Drug:
• Dexamethasone 20mg
Periarticular dexamethasone injection

Locations

Country	Name	City	State
Canada	Salem Anaesthesia Pain Clinic	Surrey	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Salem Anaesthesia Pain Clinic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sleep quality score, objective measurement using validated Likert sleep scale	Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep	12 weeks