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Steroid Injection for Sickle Cell Arthropathy Pain Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05983055
Recruitment Status : Completed
First Posted : August 9, 2023
Last Update Posted : May 14, 2024
Sponsor:
Information provided by (Responsible Party):
Salem Anaesthesia Pain Clinic

Study Description
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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
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
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Study Type : Observational
Actual 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 : January 30, 2018
Actual Primary Completion Date : March 31, 2023
Actual Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

Groups and Cohorts
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Intervention Details:
  • Drug: Dexamethasone 20mg
    Periarticular dexamethasone injection
    Other Name: Dexamethasone injection

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05983055


Locations
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Canada, British Columbia
Salem Anaesthesia Pain Clinic
Surrey, British Columbia, Canada, V3S 7J1
Sponsors and Collaborators
Salem Anaesthesia Pain Clinic
Investigators
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Principal Investigator: Olumuyiwa Bamgbade, MD,FRCPC Salem Anaesthesia Pain Clinic
More Information
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Responsible Party: Salem Anaesthesia Pain Clinic
ClinicalTrials.gov Identifier: NCT05983055    
Other Study ID Numbers: SalemAn2018 SCD arthro injectn
First Posted: August 9, 2023    Key Record Dates
Last Update Posted: May 14, 2024
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Joint Diseases
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Musculoskeletal Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action