Sickle Cell DiseaseNCT05983055
Steroid Injection for Sickle Cell Arthropathy Pain Therapy
An observational study of Sickle Cell Disease and Sickle Cell Abnormality, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 20 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease, Sickle Cell Abnormality
- What is being tested?
- Dexamethasone 20mg
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2018to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A cohort of consecutive adult patients who underwent pain management at a pain clinic
Who may be able to join
- 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
Who cannot join
- pediatric patients
- patient without sickle cell disease arthropathy
- patient without periarticular steroid injection
- irregular sleep diary
- irregular pain diary
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sickle Cell Disease, Sickle Cell Abnormality
- Being tested
- Dexamethasone 20mg
- Keywords
- Sickle cell
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 20mgDrug
Also called Dexamethasone injection
Periarticular dexamethasone injection
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (1)
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start30 Jan 2018
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salem Anaesthesia Pain Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olumuyiwa Bamgbade, MD,FRCPC, Principal investigator, Salem Anaesthesia Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983055
- Sponsor's protocol ID
- SalemAn2018 SCD arthro injectn
- Status last verified
- Jan 2025
- First submitted
- 1 Aug 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suitability of Periarticular Steroid Injections for Sickle Cell Arthropathy Pain Therapy
- ClinicalTrials.gov ID
- NCT05983055
- Acronym / sponsor ID
- SalemAn2018 SCD arthro injectn
- Conditions
- Sickle Cell Disease, Sickle Cell Abnormality
- Keywords
- Sickle cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Salem Anaesthesia Pain ClinicUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of consecutive adult patients who underwent pain management at a pain clinic
Key inclusion criteria (6 listed)
- adult chronic pain patients
- sickle cell disease arthropathy
- periarticular steroid injection therapy
- regular sleep diary
- regular pain diary
Key exclusion criteria (5 listed)
- pediatric patients
- patient without sickle cell disease arthropathy
- patient without periarticular steroid injection
- irregular sleep diary
- irregular pain diary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone 20mgAlso: Dexamethasone injectionPeriarticular dexamethasone injection | Drug | – |
Primary outcome
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
1 secondary outcome
Sleep quality score, objective measurement using validated Likert sleep scale
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olumuyiwa Bamgbade, MD,FRCPC principal investigator
Salem Anaesthesia Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and Sickle Cell Abnormality, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain score, objective measurement using validated Numeric Pain Rating scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.