Validation of the Pain Relief Measure
CompletedNCT05294432
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Brief summary (from the registry)
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 standards for pain measurement.
Study details
- Official title
- Preliminary Validation of the Integral of Pain Relief as a Measure of Pain Relief in Chronic Pain Patients
- Conditions
- Sponsor
- Wilderman Medical Clinic
- Start date
- 2019-03-28
- Primary completion
- 2024-10-21
- Sex
- All
- Age range
- from 40 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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.
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05294432