Steroid Injection for Sickle Cell Arthropathy Pain Therapy

• Sponsor: Salem Anaesthesia Pain Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05983055
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 71
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sickle Cell Disease; Sickle Cell Abnormality	Drug: Dexamethasone 20mg

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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Suitability of Periarticular Steroid Injections for Sickle Cell Arthropathy Pain Therapy
• Actual Study Start Date: Jan 30, 2018
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Salem Anaesthesia Pain Clinic	Surrey	British Columbia	Canada	V3S 7J1

Sponsors and Collaborators

• Salem Anaesthesia Pain Clinic

Investigators

• Principal Investigator: Olumuyiwa Bamgbade, MD,FRCPC, Salem Anaesthesia Pain Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Salem Anaesthesia Pain Clinic
• ClinicalTrials.gov Identifier: NCT05983055
• Other Study ID Numbers: SalemAn2018 SCD arthro injectn
• First Posted: Aug 9, 2023
• Last Update Posted: Aug 14, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Salem Anaesthesia Pain Clinic: Sickle cell
• Additional relevant MeSH terms: Joint Diseases; Anemia, Sickle Cell; Dexamethasone; Dexamethasone acetate; BB 1101

Study Results

No Results Posted as of Aug 14, 2023