An observational study in Chronic Pain, sponsored by Wilderman Medical Clinic. Completed at 1 site in Canada. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by Wilderman Medical Clinic · Observational
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:
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's enrollment of 97 is below the median of 120 across 753 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →Wilderman Medical Clinic is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients of Wilderman Medical Clinic diagnosed with symptomatic Osteoarthritis of the Knee who were prescribed with at least one intra-articular corticosteroid injection.
Integral of Pain Relief (dimensions)
Patient's reported percentage (%) and duration of pain relief (days)
Time frame: Post-interventional at week 2
Integral of Pain Relief (dimensions)
Patient's reported percentage (%) and duration of pain relief (days)
Time frame: Post-interventional at week 4
Integral of Pain Relief (dimensions)
Patient's reported percentage (%) and duration of pain relief (days)
Time frame: Post-interventional at week 6
Integral of Pain Relief (dimensions)
Patient's reported percentage (%) and duration of pain relief (days)
Time frame: Post-interventional at week 8
Integral of Pain Relief (dimensions)
Patient's reported percentage (%) and duration of pain relief (days)
Time frame: 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).
Time frame: Baseline, post-interventional at week 2
Pain Intensity Numeric Rating Scale
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post-interventional at week 12
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.
Time frame: Baseline, Post-intervention at week 2
Use of Analgesic Medication
Change in average consumption of analgesic medication (days) as per patient's daily diary from baseline to 4 weeks post-interventional.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Post-interventional at 12 weeks
Plan to share: Undecided
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Wilderman Medical Clinic