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Pain Informed Movement for Knee Osteoarthritis

N/A
Recruiting
Led By Lisa Carlesso, PhD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will compare two interventions for knee osteoarthritis to see if there are differences in pain, functional leg strength, pain modulation, and psychological factors.

Who is the study for?
This trial is for people over 40 with knee osteoarthritis who've had regular pain in the past month. They must speak English, have internet access, and be able to move without help. It's not for those with recent knee trauma/surgery, injections in the knee within 3 months, or involved in other OA trials.Check my eligibility
What is being tested?
The study compares a pain informed movement program plus Pain Neuroscience Education (PNE) against standard neuromuscular exercises with basic OA education. It checks which is more feasible and satisfactory for patients and measures effects on pain, function, quality of life, strength, nerve factors.See study design
What are the potential side effects?
While specific side effects are not listed here as it's an exercise-based intervention rather than drug-related; general risks may include muscle soreness or strain from physical activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are at least 45 years old and have knee pain that gets worse with activity, even if it's just in the morning and lasts for about 30 minutes.
Select...
You experience mild to moderate pain most days, with an average intensity of 3 out of 10 on a pain scale.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of follow up
Secondary outcome measures
Frequency of the program measured on a 5 point Likert scale
Rate of recruitment measured by number of people recruited in a year
Usefulness of the education content measured on a 5 point Likert scale
+5 more
Other outcome measures
30 Second Sit to Stand Test
Brief Fear of Movement Scale for Osteoarthritis (BFMSO)
Conditioned Pain modulation (CPM) measured with PPT test stimulus and conditioning stimulus of forearm ischemia
+16 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pain Informed Movement and pain neuroscience educationExperimental Treatment2 Interventions
Participants will receive a twice weekly, 8 week in-person group exercise program, consisting of exercise instruction (75 minutes) and pain neuroscience education (PNE) videos (20 to 30 minutes/week for the first 4 weeks). During the exercise sessions, the educational components and concepts such as mindfulness, muscle tension regulation, and breathing techniques will be applied by the instructor. A third home session (weekly) will be facilitated by exercise handout sheets. The exercise component will be delivered by an experienced yoga teacher that has been extensively trained. The PNE video component will cover the following topics: The purpose of pain, neurophysiological changes of pain, movement guidelines when pain persists, and self-care techniques to impact neurophysiology and support moving with ease that include breath awareness and regulation, muscle tension regulation, awareness of pain related thoughts and emotions, relaxation, and body awareness.
Group II: Standard neuromuscular exercise and OA educationActive Control2 Interventions
Participants in this group will receive an 8-week in-person group exercise program held twice weekly, in which they will receive exercise instructions (60 minutes) and standard osteoarthritis (OA) education (15 to 20 minutes/week for the first 4 weeks). A third home session (weekly) will be facilitated by exercise handout sheets. The exercise component (i.e., the specific movements) of this group will be similar to those of the other group without the added techniques of breath awareness and regulation, muscle tension regulation, awareness of pain related thoughts and emotions, relaxation, and body awareness. The standard OA education videos will cover the following topics: common OA symptoms, risk factors associated with knee OA, and the effects of exercise and self-management tips. The exercise and education components will be delivered by a physiotherapist in the research team.

Find a Location

Who is running the clinical trial?

Boston UniversityOTHER
454 Previous Clinical Trials
9,941,504 Total Patients Enrolled
11 Trials studying Osteoarthritis
5,864 Patients Enrolled for Osteoarthritis
University of British ColumbiaOTHER
1,413 Previous Clinical Trials
2,466,895 Total Patients Enrolled
26 Trials studying Osteoarthritis
1,901 Patients Enrolled for Osteoarthritis
University of MelbourneOTHER
166 Previous Clinical Trials
1,287,374 Total Patients Enrolled
12 Trials studying Osteoarthritis
703,222 Patients Enrolled for Osteoarthritis

Media Library

Pain Informed Movement Clinical Trial Eligibility Overview. Trial Name: NCT05730829 — N/A
Osteoarthritis Research Study Groups: Standard neuromuscular exercise and OA education, Pain Informed Movement and pain neuroscience education
Osteoarthritis Clinical Trial 2023: Pain Informed Movement Highlights & Side Effects. Trial Name: NCT05730829 — N/A
Pain Informed Movement 2023 Treatment Timeline for Medical Study. Trial Name: NCT05730829 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study accept individuals aged 65 or older as participants?

"Participants who meet the eligibility criteria of this medical study must be between 40 and 85 years old."

Answered by AI

Are new participants currently being enrolled for this research endeavor?

"According to clinicaltrials.gov, the study is not currently recruiting patients; it was initially posted on April 1st 2023 and last updated February 7th of that year. Although no longer accepting candidates, there are 682 alternative trials actively admitting participants at this time."

Answered by AI

Who is the target demographic for this medical research endeavor?

"For this clinical trial, 66 patients between the ages of 40 and 85 with a physician diagnosed osteoarthritis in their knee are being recruited. To be eligible for participation, applicants must meet any one of these three criteria: (1) ≥40 years old and having been given an OA diagnosis by a doctor; (2) ≥45 years old with joint pain that lasts for 30 minutes or more on days when they engage in physical activity; (3) Averaging 3/10 intensity on a numeric pain scale over the course of last month."

Answered by AI
~9 spots leftby Jul 2024