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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.
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 experiencing acute or chronic pain is a change in the numerical rating scale (NRS) score. NRS is a unidimensional scale that requires patients to mark their pain level from 0 (no pain) to 10 (worst pain). The NRS provides practitioners with pain levels pre-and-post treatment and is used as an indication of treatment efficacy. A significant limitation of the NRS, however, is that it provides an estimation of a single dimension of pain, pain intensity. Pain and pain relief, on the other hand, may have many dimensions including pain intensity, duration and magnitude of pain relief. Current multidimensional measures fail to capture duration of pain relief, thus there is a necessity to improve pain assessment tools. The integral of pain relief (IPR) is a novel two-dimensional measure of pain relief and duration of pain relief following treatment and may provide a more accurate depiction of post-treatment pain as well as intervention effectiveness. In this prospective cohort study, we intend to assess the validity of the IPR using validated measures of change in pain intensity (NRS), and the Patients' Global Impression of Change (PGIC) as well as The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in patients treated with corticosteroid injections for the osteoarthritis of knee joint.
The primary objectives of this study include:
Secondary objectives of this study include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group | Patients of Wilderman Medical Clinic diagnosed with symptomatic Osteoarthritis of the Knee who were prescribed with at least one intra-articular corticosteroid injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Integral of Pain Relief (dimensions) | Patient's reported percentage (%) and duration of pain relief (days) | Post-interventional at week 2 |
| Integral of Pain Relief (dimensions) | Patient's reported percentage (%) and duration of pain relief (days) | Post-interventional at week 4 |
| Integral of Pain Relief (dimensions) | Patient's reported percentage (%) and duration of pain relief (days) | Post-interventional at week 6 |
| Integral of Pain Relief (dimensions) | Patient's reported percentage (%) and duration of pain relief (days) | Post-interventional at week 8 |
| Integral of Pain Relief (dimensions) | Patient's reported percentage (%) and duration of pain relief (days) | Post-interventional at week 12 |
| Change in Pain Intensity Numeric Rating Scale (NRS) score | Change in average daily (24-hr) pain intensity scores (NRS) from baseline to 2 weeks post-interventional. Numeric Rating Scale pain intensity score is recorded daily via pain diary starting from day -7 (one week before baseline). Numeric Rating Scale pain intensity score is recorded daily via pain diary. Numeric Rating Scale is a one-dimensional measure of pain intensity. The pain intensity is rated by participant using a scale from 0 to 10, 0 being the least (no pain) to 10 (worst pain imaginable). | Baseline, post-interventional at week 2 |
| Pain Intensity Numeric Rating Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Analgesic Medication | Change in average consumption of analgesic medication (days) as per patient's daily diary from baseline to 2 weeks post-interventional. | Baseline, Post-intervention at week 2 |
| Use of Analgesic Medication |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of Wilderman Medical Clinic ≥40 years of age diagnosed with symptomatic Osteoarthritis of the Knee who are prescribed at least one corticosteroid intra-articular injection into the knee.
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| Name | Affiliation | Role |
|---|---|---|
| Igor Wilderman, MD | Wilderman Medical Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilderman Medical Clinic | Thornhill | Ontario | L4J 1W3 | Canada |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Change in average daily (24-hr) pain intensity scores from baseline to 4 weeks post-interventional. Numeric Rating Scale pain intensity score is recorded daily via pain diary starting from day -7 (one week before baseline). Numeric Rating Scale pain intensity score is recorded daily via pain diary. Numeric Rating Scale is a one-dimensional measure of pain intensity. The pain intensity is rated by participant using a scale from 0 to 10, 0 being the least (no pain) to 10 (worst pain imaginable). |
| Baseline, post-interventional at week 4 |
| Pain Intensity Numeric Rating Scale (NRS) | Change in average daily (24-hr) pain intensity scores (NRS) from baseline to 6 weeks post-interventional. Numeric Rating Scale pain intensity score is recorded daily via pain diary starting from day -7 (one week before baseline). Numeric Rating Scale pain intensity score is recorded daily via pain diary. Numeric Rating Scale is a one-dimensional measure of pain intensity. The pain intensity is rated by participant using a scale from 0 to 10, 0 being the least (no pain) to 10 (worst pain imaginable). | Baseline, post-interventional at week 6 |
| Pain Intensity Numeric Rating Scale (NRS) | Change in average daily (24-hr) pain intensity scores (NRS) from baseline to 8 weeks post-interventional. Numeric Rating Scale pain intensity score is recorded daily via pain diary starting from day -7 (one week before baseline). Numeric Rating Scale pain intensity score is recorded daily via pain diary. Numeric Rating Scale is a one-dimensional measure of pain intensity. The pain intensity is rated by participant using a scale from 0 to 10, 0 being the least (no pain) to 10 (worst pain imaginable). | Baseline, post-interventional at week 8 |
| Pain Intensity Numeric Rating Scale (NRS) | Change in average daily (24-hr) pain intensity scores (NRS) from baseline to 12 weeks post-interventional. Numeric Rating Scale pain intensity score is recorded daily via pain diary starting from day -7 (one week before baseline). Numeric Rating Scale pain intensity score is recorded daily via pain diary. Numeric Rating Scale is a one-dimensional measure of pain intensity. The pain intensity is rated by participant using a scale from 0 to 10, 0 being the least (no pain) to 10 (worst pain imaginable). | Baseline, post-interventional at week 12 |
| Western Ontario and McMaster Universities (WOMAC® 3.1) Osteoarthritis Index | Change in total score from baseline to 2 weeks post-interventional. Western Ontario and McMaster Universities (WOMAC® 3.1) Osteoarthritis Index is a Likert 5 point scale for pain, stiffness and function domains. Activities in each domain are rated by a study participant according to the following scale of difficulty: 0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely. | Baseline, post-interventional at weeks 2 |
| Western Ontario and McMaster Universities (WOMAC® 3.1) Osteoarthritis Index | Change in total score from baseline to 4 weeks post-interventional. Western Ontario and McMaster Universities (WOMAC® 3.1) Osteoarthritis Index is a Likert 5 point scale for pain, stiffness and function domains. Activities in each domain are rated by a study participant according to the following scale of difficulty: 0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely. | Baseline, post-interventional at week 4 |
| Western Ontario and McMaster Universities (WOMAC® 3.1) Osteoarthritis Index | Change in total score from baseline to 6 weeks post-interventional. Western Ontario and McMaster Universities (WOMAC® 3.1) Osteoarthritis Index is a Likert 5 point scale for pain, stiffness and function domains. Activities in each domain are rated by a study participant according to the following scale of difficulty: 0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely. | Baseline, post-interventional at week 6 |
| Western Ontario and McMaster Universities (WOMAC® 3.1) Osteoarthritis Index | Change in total score from baseline to 8 weeks post-interventional. Western Ontario and McMaster Universities (WOMAC® 3.1) Osteoarthritis Index is a Likert 5 point scale for pain, stiffness and function domains. Activities in each domain are rated by a study participant according to the following scale of difficulty: 0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely. | Baseline, post-interventional at week 8 |
| Western Ontario and McMaster Universities (WOMAC® 3.1) Osteoarthritis Index | Change in total score from baseline to 12 weeks post-interventional. Western Ontario and McMaster Universities (WOMAC® 3.1) Osteoarthritis Index is a Likert 5 point scale for pain, stiffness and function domains. Activities in each domain are rated by a study participant according to the following scale of difficulty: 0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely. | Baseline, post-interventional at week 12 |
| Patient's Global Impression of Change (PGIC) | Patient's Global Impression of Change (PGIC) scores from Baseline to 2 weeks post-interventional. Patient's Global Impression of Change (PGIC) is a 7-point single item scale ranging from "very much worse" to "very much improved" with "no change" with "no change" at mid-point that evaluated improvement in overall status with treatment during clinical trial. | Post-interventional at week 2 |
| Patient's Global Impression of Change (PGIC) | Patient's Global Impression of Change (PGIC) scores from Baseline to 4 weeks post-interventional. Patient's Global Impression of Change (PGIC) is a 7-point single item scale ranging from "very much worse" to "very much improved" with "no change" with "no change" at mid-point that evaluated improvement in overall status with treatment during clinical trial. | Post-interventional at week 4 |
| Patient's Global Impression of Change (PGIC) | Patient's Global Impression of Change (PGIC) scores from Baseline to 6 weeks post-interventional. Patient's Global Impression of Change (PGIC) is a 7-point single item scale ranging from "very much worse" to "very much improved" with "no change" with "no change" at mid-point that evaluated improvement in overall status with treatment during clinical trial. | Post-interventional at week 6 |
| Patient's Global Impression of Change (PGIC) | Patient's Global Impression of Change (PGIC) scores from Baseline to 8 weeks post-interventional. Patient's Global Impression of Change (PGIC) is a 7-point single item scale ranging from "very much worse" to "very much improved" with "no change" with "no change" at mid-point that evaluated improvement in overall status with treatment during clinical trial. | Post-interventional at week 8 |
| Patient's Global Impression of Change (PGIC) | Patient's Global Impression of Change (PGIC) scores from Baseline to 12 weeks post-interventional. Patient's Global Impression of Change (PGIC) is a 7-point single item scale ranging from "very much worse" to "very much improved" with "no change" with "no change" at mid-point that evaluated improvement in overall status with treatment during clinical trial. | Post-interventional at week 12 |
Change in average consumption of analgesic medication (days) as per patient's daily diary from baseline to 4 weeks post-interventional.
| Baseline, Post-intervention at week 4 |
| Use of Analgesic Medication | Change in average consumption of analgesic medication (days) as per patient's daily diary from baseline to 6 weeks post-interventional. | Baseline, Post-intervention at week 6 |
| Use of Analgesic Medication | Change in average consumption of analgesic medication (days) as per patient's daily diary from baseline to 8 weeks post-interventional. | Baseline, Post-intervention at week 8 |
| Use of Analgesic Medication | Change in average consumption of analgesic medication (days) as per patient's daily diary from baseline to 12 weeks post-interventional. | Baseline, Post-intervention at week 12 |
| Patient's Survey | Patient's impression on completing daily pain diary versus providing percentage and duration of pain relief | Post-interventional at 12 weeks |