Knee Osteoarthritis Clinical Trial
Official title:
Pain Informed Movement for People With Knee Osteoarthritis: A Pilot and Feasibility Randomized Controlled Trial
NCT number | NCT05730829 |
Other study ID # | HiREB 15700 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 3, 2023 |
Est. completion date | July 2024 |
The goal of this clinical trial is to compare a pain informed movement program to standard neuromuscular exercise in people with knee osteoarthritis. The main question it aims to answer are: 1. Are the two interventions a) pain informed movement program plus pain neuroscience education and b) neuromuscular exercise plus standard osteoarthritis education feasible in terms of recruitment, treatment adherence, timelines, data collection procedures, patient follow-up, and resources required? 2. Is there a difference in patient's satisfaction and acceptability of the two programs? 3. Are there any differences in the potential effects of the two programs on subjective pain measures, self-reported function, quality of life, functional leg strength, nervous system pain modulation, brain derived neurotrophic factor and nerve growth factor levels, and psychological factors?
Status | Recruiting |
Enrollment | 66 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility | Inclusion Criteria: - - =40 years of age with diagnosis of knee osteoarthritis (OA) by a physician OR; - =45 years of age and having activity-related knee joint pain with or without morning stiffness lasting 30 minutes (NICE criteria) - Having an average pain intensity of 3/10 on a numeric pain scale on most days of the past month Exclusion Criteria: - Cannot communicate in English; - Has inflammatory arthritis or other systemic conditions; - Have had lower limb trauma or surgery within the past 6 months; - Have participated in a knee OA exercise program in the prior 3 months; - Have had any injection in the index knee within 3-months prior to baseline assessment - Does not have regular access to the internet - Inability to get up and down from the floor independently - Use of mobility aids - Currently participating in any other drug/device/exercise clinical trial related to OA - Planned absences (e.g., trips away) of >1 week - Currently receiving other forms of care for knee OA pain (e.g., from a physiotherapist, chiropractor, athletic therapist, kinesiologist) - Does not meet screening for safe participation in exercise according to the Get Active questionnaire from the Canadian Society for Exercise Physiology |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Boston University, University of British Columbia, University of Melbourne |
Canada,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Modified Charlson comorbidity index | to assesses the presence of comorbidities minimum score = 0, maximum = 20 with higher scores indicating greater severity. | baseline | |
Other | participant characteristics | Age, sex, gender, education, marital status, race, number of people living with, height | baseline | |
Other | Weight | Weight | baseline and 8 weeks | |
Other | Medication use | any medication that they take on a regular schedule | baseline and 8 weeks | |
Other | Perspectives on knee replacement surgery | Three questions will be asked: 1. Are your knee symptoms so severe that you wish to undergo knee replacement surgery? 2. Do you think knee replacement surgery is eventually inevitable? 3. In your opinion, what factor(s) can lead to better outcomes after knee replacement surgery? | baseline and 8 weeks | |
Other | Other painful body parts | Using a body diagram, participants will be asked to indicate any other areas where they experience pain | baseline and 8 weeks | |
Other | Mechanical Temporal Summation (TS) | to assess central sensitization using weighted probes. Pain rated after first stimulus and after 10th. TS calculated as difference from first to second. | baseline and 8 weeks | |
Other | Conditioned Pain modulation (CPM) measured with PPT test stimulus and conditioning stimulus of forearm ischemia | First stimulus of pressure pain threshold is delivered, next ischemic forearm test is conducted to a 4/10 and then PPT is repeated. An index will be created by calculating the percent efficiency of CPM (%CPM) as PPT2/PPT1, multiplied by 100; whereby %CPM = 100 indicates inefficient pain modulation CPM. There are no standard minimum or maximum values. | baseline and 8 weeks | |
Other | Pain intensity measured on the NRS | Three ratings: average pain intensity in the past 24 hours, past week, and worst pain in the past 24 hours will be recorded on a 0 1- numeric rating scale | baseline and 8 weeks | |
Other | Pain Catastrophizing Scale (PCS) | 13 questions for a total score of 52 with higher scores indicating more severe symptoms. Minimum score = 0, maximum score 52 | baseline and 8 weeks | |
Other | Self-Efficacy for Managing Chronic Disease 6-item scale (SEMCD-6) | measure of self-efficacy rated on 0-10 scale ranging from not at all confident to entirely confident | baseline and 8 weeks | |
Other | Hospital Anxiety and Depression Scale (HADS) | to assess anxiety and depression 7 questions each 0-3 with a total of 42 | baseline and 8 weeks | |
Other | Brief Fear of Movement Scale for Osteoarthritis (BFMSO) | 6 items to assess activity avoidance of participants due to pain-related fear of movement rated on a 4 point scale ranging from strongly disagree to strongly agree | baseline and 8 weeks | |
Other | Knee Injury and Osteoarthritis Outcome Score (KOOS) | to assess self-reported opinions about patients' knee and associated problems. Subscale of pain, activities of daily living and quality of life consisting of ratings of amount of pain and difficulty respectively from none to extreme. Scores are converted to out of 100 with higher scores indicating lower pain and higher function. Minimum scores are 0 and maximum scores are 20 and 68 for the pain and ADL subscales respectively. | baseline and 8 weeks | |
Other | Intermittent and Constant Osteoarthritis Pain (ICOAP) knee version | Intermittent and constant pain subscales 11 items scored from 0-4 totalling 44 and converted to a percentage out of 100. | baseline and 8 weeks | |
Other | 30 Second Sit to Stand Test | to measure functional leg strength and endurance by counting the numbers of complete movements accomplished in the allotted time | baseline and 8 weeks | |
Other | serum levels of brain derived neurotrophic factors (BDNF) via blood analysis | a neurotrophin level measured in pg/ml | baseline and 8 weeks | |
Other | serum levels of nerve growth factor (NGF) via blood analysis | a neurotrophin level measured in pg/ml | baseline and 8 weeks | |
Other | perspectives on the effectiveness of the different intervention components on managing pain | One question will be asked of participants in each arm to rank the effectiveness of the different components of the intervention they received. e.g. "Please rank the different components of the intervention you received in order of how effective they are for managing your pain." A list of the different components in each study arm will be provided e.g. education videos, strengthening exercise, mind-body techniques | 8 weeks | |
Primary | Percentage of follow up | percentage rate measured by those at baseline completing study follow up measures | 8 weeks | |
Secondary | Usefulness of the program for managing knee OA measured on a 5 point Likert scale | Likert scale anchored from Not useful at all to very useful | 8 weeks | |
Secondary | Usefulness of the education content measured on a 5 point Likert scale | Likert scale anchored from Not useful at all to very useful | 8 weeks | |
Secondary | Frequency of the program measured on a 5 point Likert scale | Likert scale anchored from not frequent enough to Frequent enough | 8 weeks | |
Secondary | frequency of the educational sessions measured on a 5 point Likert scale | Likert scale anchored from not frequent enough to Frequent enough | 8 weeks | |
Secondary | Rate of recruitment measured by number of people recruited in a year | recruitment rate is a minimum of 40 people in a year | 1 year | |
Secondary | burdensomeness of study procedures (questionnaires, tests, blood draws) measured on 0-10 scale | burdensomeness rating between 0 (no burden at all) to 10 (very much a burden) | 8 weeks | |
Secondary | rate of adherence measured by percentage of sessions attended and home sessions completed | adherence rate calculated from attendance and exercise tracking sheets | 8 weeks | |
Secondary | rate of adverse events measured by question regarding symptom flare and seeking treatment | measured as any problem that lasts for >2 days and/or causes the participant to seek other treatment | 8 weeks |
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