Steroid Injection for Sickle Cell Arthropathy Pain Therapy

August 9, 2023 updated by: Salem Anaesthesia Pain Clinic

Suitability of Periarticular Steroid Injections for Sickle Cell Arthropathy Pain Therapy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3S 7J1
        • Recruiting
        • Salem Anaesthesia Pain Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric pain score, objective measurement using validated Numeric Pain Rating scale
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep quality score, objective measurement using validated Likert sleep scale
Time Frame: 12 weeks
Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salem Anaesthesia Pain Clinic

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2018

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SalemAn2018 SCD arthro injectn

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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