Status:
COMPLETED
Validation of the Pain Relief Measure
Lead Sponsor:
Wilderman Medical Clinic
Conditions:
Chronic Pain
Eligibility:
All Genders
40+ years
Brief Summary
The purpose of this study is to provide evidence for the empirical and clinical utility of a novel pain relief measure, the IPR, dimensions of which will be validated against the present gold standard...
Detailed Description
There are a number of validated unidimensional and multidimensional tools used to measure pain levels. The present widely used in clinical practice standard measure of pain relief in patients experien...
Eligibility Criteria
Inclusion
- Given written Informed Consent to participate in the study
- Male or female ≥40 years of age
- Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening requiring the use of regular therapies.
- If bilateral OA exists, pain in the contralateral knee must be less than pain in the index knee as reported by patient
- Index knee pain on most days (\>15) over the last month
- Mean score of ≥4 and ≤9 on the 24-hr average pain score (0-10 NRS) using the average daily ratings at least 5 out of 7 days prior to Day 1(Baseline)
- Have been prescribed and scheduled to receive at least one corticosteroid (triamcinolone) injection to the affected knee
- Willingness and ability to comply with the study procedures and visit schedules and the ability to follow verbal and written instructions
Exclusion
- Lack of signed Informed Consent Form
- Age less than 40 years old
- Have any contraindications to administration of corticosteroid medication by intra-articular injection
- Patients with diagnoses of fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
- Patients with diagnoses of rheumatoid arthritis, psoriatic arthritis, or any other form of inflammatory arthritis
- Planned/anticipated surgery in the affected area within 3 months during the study period.
- Previous intra-articular corticosteroid injection into the index joint within 3 months prior to Screening
- Concomitant treatment with corticosteroid or other injections into the index joint (e.g. prolotherapy) within 3 months during the study period
- Concomitant treatment with oral or topical (to the index knee) corticosteroids within 3 months during the study period (except inhaled, intranasal, or topical applied not to the index knee)
- Any other investigational drug/biologic applied to affected area within 3 months during the study period
- Diagnosis of dementia or other cognitive impairments that would preclude questionnaires completion
- Any clinically significant acute or chronic medical conditions that, in the judgment of Investigator, would preclude the use of corticosteroid injections or that could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study
- Participation in any other clinical study within 3 months prior to Screening and during the study period.
Key Trial Info
Start Date :
March 28 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 21 2024
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT05294432
Start Date
March 28 2019
End Date
October 21 2024
Last Update
March 25 2025
Active Locations (1)
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1
Wilderman Medical Clinic
Thornhill, Ontario, Canada, L4J 1W3