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Completed

NCT Number: NCT05983055

Steroid Injection 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.

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Key information

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, V3S 7J1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone 20mg

Drug

Periarticular dexamethasone injection

Other names: Dexamethasone injection

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Salem Anaesthesia Pain Clinic

Other

Registry information

Official study title

Suitability of Periarticular Steroid Injections for Sickle Cell Arthropathy Pain Therapy

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2023
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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