Trial Outcomes & Findings for Feasibility of Pain Informed Movement for Knee OA (NCT NCT04954586)

Results Overview

A Likert scale out of 5 will assess how useful participants found the treatment. The minimum value is 1 and the maximum value is 5, with higher scores indicating a better outcome. The count of participants that reported the acceptability of content \>4/5 is reported and considered for proceeding with the study without protocol amendment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

8 weeks

Results posted on

2024-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	Pain Informed Movement This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Overall Study STARTED	19
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Pain Informed Movement This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Overall Study Withdrawal by Subject	5

Baseline Characteristics

Feasibility of Pain Informed Movement for Knee OA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pain Informed Movement n=19 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Age, Continuous	63.3 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
BMI (kg/m^2)	30.50 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

A Likert scale out of 5 will assess how useful participants found the treatment. The minimum value is 1 and the maximum value is 5, with higher scores indicating a better outcome. The count of participants that reported the acceptability of content \>4/5 is reported and considered for proceeding with the study without protocol amendment.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Acceptability of Content	13 Participants

PRIMARY outcome

Timeframe: 8 weeks

A Likert scale out of 5 will assess how acceptable participants found the frequency of the treatment. The minimum value is 1 and the maximum value is 5, with higher scores indicating a better outcome. The count of participants that reported the acceptability of frequency \>4/5 is reported and considered for proceeding with the study without protocol amendment.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Acceptability of Frequency	13 Participants

PRIMARY outcome

Timeframe: 8 weeks

A Likert scale out of 5 will assess how acceptable participants found the duration of the treatment. The minimum value is 1 and the maximum value is 5, with higher scores indicating a better outcome. The count of participants that reported the acceptability of duration \>4/5 is reported and considered for proceeding with the study without protocol amendment.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Acceptability of Duration	11 Participants

PRIMARY outcome

Timeframe: 8 weeks

A numeric rating scale out of 10 will assess how burdensome participants found completing the questionnaires. On this scale,1 represents no burden at all and 10 represents very much a burden. Higher scores indicate a worse outcome. There is no minimum or maximum value. The count of participants that reported the burden \<3/10 is reported and considered for proceeding with the study without protocol amendment

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Burden of Questionnaires	14 Participants

PRIMARY outcome

Timeframe: 8 weeks

A numeric rating scale out of 10 will assess how burdensome participants found completing the physical tests. On this scale,1 represents no burden at all and 10 represents very much a burden. Higher scores indicate a worse outcome. The count of participants that reported the burden \<3/10 is reported and considered for proceeding with the study without protocol amendment.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Burden of Physical Tests	14 Participants

PRIMARY outcome

Timeframe: 8 weeks

Number of eligible participants who consent to participate in 1 month.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=19 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Recruitment Rate	19 Participants

PRIMARY outcome

Timeframe: 8 weeks

Percentage of participants who follow-up at 8 weeks.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=19 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Follow-Up Rate	14 Participants

PRIMARY outcome

Timeframe: 8 weeks

Percentage of participants who did not experience any adverse events or only mild transient.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Self Reported Adverse Events	14 Participants

PRIMARY outcome

Timeframe: 8 weeks

Percentage of participants who report exercising at least 3 times a week.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Exercise Completion	13 Participants

PRIMARY outcome

Timeframe: 8 weeks

Adherence to the program. This is the number of sessions that were attended by the participants. There are 2 sessions per week for 8 weeks, for a total of 16 sessions per participants. With 14 participants being in the study, the total number of sessions to be attended is 224. The number of sessions that were actually attended is being reported.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Adherence	204 sessions

PRIMARY outcome

Timeframe: 8 weeks

Likelihood of recommending the program to others. On a scale of 1 to 5, participants rate how likely they would recommend the program to other people. On this scale, 1 is the minimum, and 5 is the maximum, with higher scores indicating a better outcome. Participants that indicate a score of 4 or 5 are counted as the number of participants that would likely recommend the program to others (the number being reported).

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Recommending the Program	13 Participants

PRIMARY outcome

Timeframe: 8 weeks

Likelihood of using the treatment again. On a scale of 1 to 5, participants rate how likely they would use the treatment again. On this scale, 1 is the minimum, and 5 is the maximum, with higher scores indicating a better outcome. Participants that indicate a score of 4 or 5 are counted as the number of participants that would likely use it again (the number being reported).

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Using the Treatment Again	13 Participants

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Pain modulation is assessed through conditioned pain modulation (CPM). First an ascending measure of pressure pain threshold (PPT) inducing a pain rating of 3/10 will be evaluated at the anterior shin on the unaffected knee. Next a conditioning stimulus in the form of forearm ischemia will be applied to induce a minimum verbal pain rating of 5/10 at the opposite volar forearm. Systolic pressure will be determined. The cuff will be inflated to 20mmhg above systolic pressure and the participant will be asked to squeeze a stress ball until a pain rating of 5/10 is reported. Once pain rating is recorded, PPT at the anterior shin will be repeated as the cuff remains inflated. 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 is no minimum or maximum value. A change between two time points (baseline and 8 weeks) is reported.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Change in Pain Modulation	0.28 Percentage of CPM Interval -18.76 to 18.21

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Pain intensity will be measured using the numeric rating scale. Questions are rated on a an 11-point scale where patients select a rating between 0 and 10 with zero representing 'no pain' while 10 represents the 'worst imaginable pain. Higher scores mean a worse outcome. A change between two time points (baseline and 8 weeks) is reported.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Change in Pain Intensity - Past 24 Hours	-1.86 score on a scale Interval -2.79 to -0.93

SECONDARY outcome

Timeframe: 8 weeks

Function will be measured using the Knee Injury and Osteoarthritis Outcome Score. The Knee Injury and Osteoarthritis Outcome Score has 42 items in 5 scored sub scales, of which two will be used: 1) pain, and 2) function in daily living (ADL). Scores range from 0-100 with zero representing extreme knee problems and 100 representing no knee problems. Higher scores mean a better outcome. A change between two time points (baseline and 8 weeks) is reported.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Change in Function	24.86 score on a scale Interval 14.46 to 36.27

SECONDARY outcome

Timeframe: 8 weeks

Brain-derived neurotrophic factor is a neurotrophin that appears to play a role in the central modulation of pain and pathophysiology of chronic pain. Blood will be drawn for analysis of brain-derived neurotrophic factor reported in ng/ml. There is no minimum or maximum values. A change between two time points (baseline and 8 weeks) is reported.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Change in Brain-derived Neurotrophic Factor	-2.36 ng/ml Interval -7.77 to 3.04

SECONDARY outcome

Timeframe: 8 weeks

Pain catastrophizing scale will be measuring pain catastrophizing. It is a 13-item self reporting instrument. Each item on the scale is rated on a 5-point scale, ranging from 0 (not at all) to 4 (all the time). The total score on the PCS is the sum of the ratings for all 13 items, ranging from 0 to 52, with higher scores indicating higher pain catastrophizing (worse outcome). Subscales are combined to get the total score. Sub-scores for 3 dimensions will be used - rumination (range 0 to 12), magnification (range 0 to 12), and helplessness (range 0 to 28). A change between two time points (baseline and 8 weeks) is reported.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Change in Pain Catastrophizing	-6.79 score on a scale Interval -10.93 to -2.64

SECONDARY outcome

Timeframe: 8 weeks

Self-Efficacy for Managing Chronic Disease is a 6-item scale. The minimum value on each item is 1 and the maximum value on each item is 10. The score for the scale is the mean of the six items. The range for the total score is 1 to 10, with higher scores indicating higher self-efficacy and mean a better outcome. A change between two time points (baseline and 8 weeks) is reported.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Change in Chronic Pain Self-efficacy	1.54 score on a scale Interval 0.09 to 2.98

SECONDARY outcome

Timeframe: 8 weeks

The 30 Second Sit to Stand Test will be used to test leg strength and endurance. The maximum number of chair stand repetitions completed during a 30 second interval will be noted along with use of any aids during testing. A change between two time points (baseline and 8 weeks) is reported.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Change in Physical Performance Tests	4.71 Numbers of sit to stands Interval 3.09 to 6.34

SECONDARY outcome

Timeframe: 8 weeks

Hospital Anxiety and Depression Scale consists of 7 questions to measure anxiety and 7 questions to measure depression. The minimum value on each item is 0 and the maximum value on each item is 3. The total score range is 0 to 21 for each subscale and higher scores represent increased severity in anxiety and depression symptoms (worse outcome). A total score can be created by combining the two subscales and the range would be from 0 to 42. A change between two time points (baseline and 8 weeks) is reported.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Change in Anxiety and Depression	0.43 score on a scale Interval -3.73 to 4.58

SECONDARY outcome

Timeframe: 8 weeks

The question being asked is: Are your knee symptoms so severe that you wish to undergo knee replacement surgery? Answer options are yes, no, or unsure. There is no minimum, maximum, or total score. Count of participants that report Yes are reported.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Change in Perspectives on Knee Replacement Surgery 1	4 Participants

SECONDARY outcome

Timeframe: 8 weeks

The question being asked is: Do you think knee replacement surgery is eventually inevitable? Answer options are yes or no. There is no minimum, maximum, or total score. Count of participants that report Yes are reported.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Change in Perspectives on Knee Replacement Surgery 2	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

The question being asked is: In your opinion, what factor(s) can lead to better outcomes after knee replacement surgery? Participants are given the following options to choose from: Good surgeon, healthy weight, good overall health, good social support, good mental health, less pain and disability before the surgery due to regular exercise, good hospital, not working (including house work), using pain killers after the surgery. Count of participants that do not choose 'less pain and disability before the surgery due to regular exercise' is reported.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Change in Perspectives on Knee Replacement Surgery 3	3 Participants

SECONDARY outcome

Timeframe: 8 weeks

Pain will also be measured using the Knee Injury and Osteoarthritis Outcome Score. The Knee Injury and Osteoarthritis Outcome Score has 42 items in 5 scored sub scales, of which two will be used: 1) pain, and 2) function in daily living (ADL). Scores range from 0-100 with zero representing extreme knee problems and 100 representing no knee problems (better outcome). A change between two time points (baseline and 8 weeks) is reported.

Outcome measures

Outcome measures
Measure	Pain Informed Movement n=14 Participants This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. Pain Informed Movement: Participants will attend a twice weekly exercise program.
Change in Pain	21.77 score on a scale Interval 11.24 to 32.3

Adverse Events

Pain Informed Movement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lisa Carlesso

McMaster University

Phone: 9055259140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place