Validation of the Pain Relief Measure

NCT05294432 | Completed

• 1 other identifier: 8054-02-2019
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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 standards for pain measurement.

Conditions

Chronic Pain

Keywords

Pain Relief; Pain Relief Measurement Tool; Integral of Pain Relief; Chronic Pain Clinical Practice

Outcome Measures

Primary Outcomes (20)

• 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

  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

Secondary Outcomes (6)

• Use of Analgesic Medication

  Baseline, Post-intervention at week 2

• Use of Analgesic Medication

  Baseline, Post-intervention at week 4

• Use of Analgesic Medication

  Baseline, Post-intervention at week 6

• Use of Analgesic Medication

  Baseline, Post-intervention at week 8

• Use of Analgesic Medication

  Baseline, Post-intervention at week 12

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wilderman Medical Clinic: lead

Study Sites (1)

Wilderman Medical Clinic

Thornhill, Ontario, L4J 1W3, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Igor Wilderman, MD

  Wilderman Medical Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 24, 2022
• Study Start: March 28, 2019
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

CA (1)