Knee OsteoarthritisNCT04954586
Feasibility of Pain Informed Movement for Knee OA
A study testing Pain Informed Movement in people with Knee Osteoarthritis, run by McMaster University at 1 site in Canada.
Trial summary
The pain experience and its associated mechanisms in people with knee osteoarthritis (OA) are known to be complex and multidimensional. The current understanding of OA pain mechanisms is incomplete, resulting in limited pain management strategies. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Pain Informed Movement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 4 May 2022to 27 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years of age and over
- Have a diagnosis of knee OA by a physician
- or fulfill the NICE criteria for knee OA diagnosis
- Have an average pain intensity of ≥3/10 on a numeric pain scale
Who cannot join
- Cannot communicate in English
- Have inflammatory arthritis or other systemic conditions
- Have had lower limb trauma
- Had surgery within the past 6-month, have participated in a similar knee OA exercise program in the prior 3-months
- Have used oral corticosteroids or had a corticosteroid injection in the index knee within 6-months prior to baseline assessment.
- Does not have access to the internet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Pain Informed Movement for People With Knee Osteoarthritis
The pain experience and its associated mechanisms in people with knee osteoarthritis (OA) are known to be complex and multidimensional. The current understanding of OA pain mechanisms is incomplete, resulting in limited pain management strategies. There is high-quality evidence that suggests the use of exercise for people with knee OA can provide a reduction in pain, changes in quality of life, and have modest improvements in physical function. There is promising evidence to support that yoga for those with knee OA may improve pain intensity, function, and stiffness. The aim of this study is to establish the feasibility of a pain informed movement program, in addition to education for improving pain modulation. The data collected will be used to inform a pilot and feasibility randomized controlled trial (RCT) prior to a multi site RCT to assess the program's effectiveness with the primary outcome of change in pain severity mediated by change in descending modulation.
Read the detailed description
Background
Exercise is regularly utilized as a first-line treatment for knee osteoarthritis, and its use is supported by high quality evidence to improve pain and function. Reductions in perceived pain can be explained in part by exercised-induced analgesia, which is thought to be mediated via numerous endogenous pathways. Furthermore, decreased nervous system sensitivity to noxious stimuli seem to play a role in the decreased pain experience of individuals who engage in exercise. These mechanisms likely play a role in improved function and reduced pain along with the improved balance, muscle strength and flexibility that are conventionally associated with exercise. In recent years multiple guidelines for non-surgical management of knee OA have begun to include mind-body therapies, such as yoga or tai-chi, as conditional or core treatment recommendations. Structured yoga programs have been shown to result in decreased pain and improved function when compared to no exercise and conventional exercise.
BDNF is a neurotrophin that appears to play an important role in the central modulation of pain in adults, and altered expression of BDNF is likely to play an important role in the pathophysiology of chronic pain. Individuals with knee OA have been shown to possess altered levels of serum BDNF compared to healthy controls, indicating that BDNF may be implicated in the pain-experience of patients with knee OA. Thus, BDNF has been identified as a therapeutic target in the treatment of pain resulting from central sensitization.
NGF is a neurotrophin known to play a critical role in the proper development of the nervous system. Evidence indicates that NGF is also involved in the increased pain experience of many individuals via peripheral sensitization of nociceptive neurons. Therefore, NGF levels have been shown to be elevated in a wide variety of chronic pain conditions including knee OA. Anti-NGF therapies are being highly studied as they have significant potential to decrease pain and improve function in individuals with OA that do not respond to conventional analgesics.
Objectives
The aim of this study is to establish the feasibility of a pain informed movement program, in addition to education for improving pain modulation. The data collected will be used to inform a pilot and feasibility randomized controlled trial (RCT) prior to a multi site RCT to assess the program's effectiveness with the primary outcome of descending modulation as a mediator of change in pain severity.
Research questions
- Is the pain informed movement and education program feasible in terms of recruitment rate, treatment adherence, timelines, data collection procedures, patient follow-up and resources required?
- Is the pain informed movement and education program feasible in terms of patient's satisfaction and acceptability?
Study Population
A convenience sample of 15 adults will be sought and is adequate to evaluate the feasibility of the program.
Recruitment
Participants will be recruited through the email lists of the McMaster Physical Activity Centre of Excellence (PACE) community. Recruitment posters will also be included in the McMaster Institute for Research on Aging (MIRA) newsletter. In addition, we will place postings on both PACE and MIRA social media pages.
Setting
The in-person 8-week exercise program will be held twice weekly at McMaster University's Physical Activity Centre of Excellence (PACE) located in the Ivor-Wynne Centre. Participants will complete the pain assessment, and have blood drawn at PACE by PACE staff who are certified phlebotomists.
Assessment
As part of participation in the study, participants will be asked to attend an assessment at the beginning of the study, and once again upon completing the 8-week exercise program. Participants will undergo pain modulation (CPM) testing, and the 30 Second Sit to Stand Test to determine leg strength and endurance. Lastly, participants will have their blood drawn at the beginning and end of the study. Participants will then be asked to complete a series of questionnaires about their pain and mood.
Exit Survey and Focus Group
A satisfaction survey will be conducted at the end of the program to evaluate the a priori feasibility criteria. Participants who indicated upon initially consenting to the study that they would like to participate in a focus group, will be contacted. Qualitative data collection will be used to explore participants experience and perceptions of the feasibility and acceptability of the program. A focus group will be conducted using audio or video recording (using Zoom), lasting between 45-60 minutes.
Statistical Analysis Plan (SAP)
All quantitative analyses will be conducted using SPSS 26. Descriptive statistics will be used to report feasibility outcomes, and survey responses will be summarized (using descriptive statistics) to identify trends in patient-reported outcomes. Qualitative interviews will be analyzed using Thematic content analysis to identify suggestions for program modification. Line-by-line reading of the transcripts will be performed by the authors and thematic patterns will be explored. Once themes and patterns are identified, each meaningful segment of text will be assigned a conceptual code. When conceptual codes become saturated, authors will build pattern codes where specific dimensions of clinicians' experiences will be clustered into recurring themes. Once the codes and themes are developed, participant and clinician partners will be invited to contribute to blinded data analysis to broaden interpretations and provide feedback on the quotes and emergent themes.
- Conditions
- Knee Osteoarthritis
- Being tested
- Pain Informed Movement
- Keywords
- Pain Management, Pain Modulation, Yoga, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Informed MovementOther
Participants will attend a twice weekly exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Pain Informed Movement | Experimental | 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. Receives: Other: Pain Informed Movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Content
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.
Measured: 8 weeks
Acceptability of Frequency
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.
Measured: 8 weeks
Acceptability of Duration
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.
Measured: 8 weeks
Burden of Questionnaires
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
Measured: 8 weeks
Burden of Physical Tests
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.
Measured: 8 weeks
Recruitment Rate
Number of eligible participants who consent to participate in 1 month.
Measured: 8 weeks
Follow-Up Rate
Percentage of participants who follow-up at 8 weeks.
Measured: 8 weeks
Self Reported Adverse Events
Percentage of participants who did not experience any adverse events or only mild transient.
Measured: 8 weeks
Exercise Completion
Percentage of participants who report exercising at least 3 times a week.
Measured: 8 weeks
Adherence
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.
Measured: 8 weeks
Recommending the Program
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).
Measured: 8 weeks
Using the Treatment Again
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).
Measured: 8 weeks
Secondary outcomes (12)
Change in Pain Modulation
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.
Measured: Baseline, 8 weeks
Change in Pain Intensity - Past 24 Hours
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.
Measured: Baseline, 8 weeks
Change in Function
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.
Measured: 8 weeks
Change in Brain-derived Neurotrophic Factor
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.
Measured: 8 weeks
Change in Pain Catastrophizing
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.
Measured: 8 weeks
Change in Chronic Pain Self-efficacy
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.
Measured: 8 weeks
Change in Physical Performance Tests
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.
Measured: 8 weeks
Change in Anxiety and Depression
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.
Measured: 8 weeks
Change in Perspectives on Knee Replacement Surgery 1
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.
Measured: 8 weeks
Change in Perspectives on Knee Replacement Surgery 2
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.
Measured: 8 weeks
Change in Perspectives on Knee Replacement Surgery 3
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.
Measured: 8 weeks
Change in Pain
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start4 May 2022
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- The Arthritis Society, Canada
- Responsible party
- Principal investigator, Lisa Carlesso, McMaster University
- Investigators
- Lisa Carlesso, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954586
- Sponsor's protocol ID
- Pain Informed Movement
- Status last verified
- Jul 2024
- First submitted
- 18 Jun 2021
- Last updated
- 3 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24.
PubMed 26405113Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
PubMed 31278997Cheung C, Wyman JF, Bronas U, McCarthy T, Rudser K, Mathiason MA. Managing knee osteoarthritis with yoga or aerobic/strengthening exercise programs in older adults: a pilot randomized controlled trial. Rheumatol Int. 2017 Mar;37(3):389-398. doi: 10.1007/s00296-016-3620-2. Epub 2016 Dec 2.
PubMed 27913870Simao AP, Mendonca VA, de Oliveira Almeida TM, Santos SA, Gomes WF, Coimbra CC, Lacerda AC. Involvement of BDNF in knee osteoarthritis: the relationship with inflammation and clinical parameters. Rheumatol Int. 2014 Aug;34(8):1153-7. doi: 10.1007/s00296-013-2943-5. Epub 2014 Jan 9.
PubMed 24399456Stoppiello LA, Mapp PI, Wilson D, Hill R, Scammell BE, Walsh DA. Structural associations of symptomatic knee osteoarthritis. Arthritis Rheumatol. 2014 Nov;66(11):3018-27. doi: 10.1002/art.38778.
PubMed 25049144Nijs J, Meeus M, Versijpt J, Moens M, Bos I, Knaepen K, Meeusen R. Brain-derived neurotrophic factor as a driving force behind neuroplasticity in neuropathic and central sensitization pain: a new therapeutic target? Expert Opin Ther Targets. 2015 Apr;19(4):565-76. doi: 10.1517/14728222.2014.994506. Epub 2014 Dec 18.
PubMed 25519921Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.
PubMed 31908163Da Silva Santos R, Galdino G. Endogenous systems involved in exercise-induced analgesia. J Physiol Pharmacol. 2018 Feb;69(1):3-13. doi: 10.26402/jpp.2018.1.01. Epub 2018 May 8.
PubMed 29769416Galdino G, Romero T, Pinho da Silva JF, Aguiar D, de Paula AM, Cruz J, Parrella C, Piscitelli F, Duarte I, Di Marzo V, Perez A. Acute resistance exercise induces antinociception by activation of the endocannabinoid system in rats. Anesth Analg. 2014 Sep;119(3):702-715. doi: 10.1213/ANE.0000000000000340.
PubMed 24977916Koltyn KF, Arbogast RW. Perception of pain after resistance exercise. Br J Sports Med. 1998 Mar;32(1):20-4. doi: 10.1136/bjsm.32.1.20.
PubMed 9562159Esser S, Bailey A. Effects of exercise and physical activity on knee osteoarthritis. Curr Pain Headache Rep. 2011 Dec;15(6):423-30. doi: 10.1007/s11916-011-0225-z.
PubMed 21956792Ghasemi GA, Golkar A, Marandi SM. Effects of hata yoga on knee osteoarthritis. Int J Prev Med. 2013 Apr;4(Suppl 1):S133-8.
PubMed 23717763Merighi A, Salio C, Ghirri A, Lossi L, Ferrini F, Betelli C, Bardoni R. BDNF as a pain modulator. Prog Neurobiol. 2008 Jul;85(3):297-317. doi: 10.1016/j.pneurobio.2008.04.004. Epub 2008 Apr 26.
PubMed 18514997Obata K, Noguchi K. BDNF in sensory neurons and chronic pain. Neurosci Res. 2006 May;55(1):1-10. doi: 10.1016/j.neures.2006.01.005. Epub 2006 Mar 3.
PubMed 16516994Binder DK, Scharfman HE. Brain-derived neurotrophic factor. Growth Factors. 2004 Sep;22(3):123-31. doi: 10.1080/08977190410001723308.
PubMed 15518235
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Pain Informed Movement for People With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04954586
- Acronym / sponsor ID
- Pain Informed Movement
- Conditions
- Knee Osteoarthritis
- Keywords
- Pain Management, Pain Modulation, Yoga, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- The Arthritis Society, Canada
- Study start
- 4 May 2022 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Posted 3 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The pain experience and its associated mechanisms in people with knee osteoarthritis (OA) are known to be complex and multidimensional. The current understanding of OA pain mechanisms is incomplete, resulting in limited pain management strategies. There is high-quality evidence that suggests the use of exercise for people with knee OA can provide a reduction in pain, changes in quality of life, and have modest improvements in physical function. There is promising evidence to support that yoga for those with knee OA may improve pain intensity, function, and stiffness. The aim of this study is to establish the feasibility of a pain informed movement program, in addition to education for improving pain modulation. The data collected will be used to inform a pilot and feasibility randomized controlled trial (RCT) prior to a multi site RCT to assess the program's effectiveness with the primary outcome of change in pain severity mediated by change in descending modulation.
Detailed description
Background
Exercise is regularly utilized as a first-line treatment for knee osteoarthritis, and its use is supported by high quality evidence to improve pain and function. Reductions in perceived pain can be explained in part by exercised-induced analgesia, which is thought to be mediated via numerous endogenous pathways. Furthermore, decreased nervous system sensitivity to noxious stimuli seem to play a role in the decreased pain experience of individuals who engage in exercise. These mechanisms likely play a role in improved function and reduced pain along with the improved balance, muscle strength and flexibility that are conventionally associated with exercise. In recent years multiple guidelines for non-surgical management of knee OA have begun to include mind-body therapies, such as yoga or tai-chi, as conditional or core treatment recommendations. Structured yoga programs have been shown to result in decreased pain and improved function when compared to no exercise and conventional exercise.
BDNF is a neurotrophin that appears to play an important role in the central modulation of pain in adults, and altered expression of BDNF is likely to play an important role in the pathophysiology of chronic pain. Individuals with knee OA have been shown to possess altered levels of serum BDNF compared to healthy controls, indicating that BDNF may be implicated in the pain-experience of patients with knee OA. Thus, BDNF has been identified as a therapeutic target in the treatment of pain resulting from central sensitization.
NGF is a neurotrophin known to play a critical role in the proper development of the nervous system. Evidence indicates that NGF is also involved in the increased pain experience of many individuals via peripheral sensitization of nociceptive neurons. Therefore, NGF levels have been shown to be elevated in a wide variety of chronic pain conditions including knee OA. Anti-NGF therapies are being highly studied as they have significant potential to decrease pain and improve function in individuals with OA that do not respond to conventional analgesics.
Objectives
The aim of this study is to establish the feasibility of a pain informed movement program, in addition to education for improving pain modulation. The data collected will be used to inform a pilot and feasibility randomized controlled trial (RCT) prior to a multi site RCT to assess the program's effectiveness with the primary outcome of descending modulation as a mediator of change in pain severity.
Research questions
- Is the pain informed movement and education program feasible in terms of recruitment rate, treatment adherence, timelines, data collection procedures, patient follow-up and resources required?
- Is the pain informed movement and education program feasible in terms of patient's satisfaction and acceptability?
Study Population
A convenience sample of 15 adults will be sought and is adequate to evaluate the feasibility of the program.
Recruitment
Participants will be recruited through the email lists of the McMaster Physical Activity Centre of Excellence (PACE) community. Recruitment posters will also be included in the McMaster Institute for Research on Aging (MIRA) newsletter. In addition, we will place postings on both PACE and MIRA social media pages.
Setting
The in-person 8-week exercise program will be held twice weekly at McMaster University's Physical Activity Centre of Excellence (PACE) located in the Ivor-Wynne Centre. Participants will complete the pain assessment, and have blood drawn at PACE by PACE staff who are certified phlebotomists.
Assessment
As part of participation in the study, participants will be asked to attend an assessment at the beginning of the study, and once again upon completing the 8-week exercise program. Participants will undergo pain modulation (CPM) testing, and the 30 Second Sit to Stand Test to determine leg strength and endurance. Lastly, participants will have their blood drawn at the beginning and end of the study. Participants will then be asked to complete a series of questionnaires about their pain and mood.
Exit Survey and Focus Group
A satisfaction survey will be conducted at the end of the program to evaluate the a priori feasibility criteria. Participants who indicated upon initially consenting to the study that they would like to participate in a focus group, will be contacted. Qualitative data collection will be used to explore participants experience and perceptions of the feasibility and acceptability of the program. A focus group will be conducted using audio or video recording (using Zoom), lasting between 45-60 minutes.
Statistical Analysis Plan (SAP)
All quantitative analyses will be conducted using SPSS 26. Descriptive statistics will be used to report feasibility outcomes, and survey responses will be summarized (using descriptive statistics) to identify trends in patient-reported outcomes. Qualitative interviews will be analyzed using Thematic content analysis to identify suggestions for program modification. Line-by-line reading of the transcripts will be performed by the authors and thematic patterns will be explored. Once themes and patterns are identified, each meaningful segment of text will be assigned a conceptual code. When conceptual codes become saturated, authors will build pattern codes where specific dimensions of clinicians' experiences will be clustered into recurring themes. Once the codes and themes are developed, participant and clinician partners will be invited to contribute to blinded data analysis to broaden interpretations and provide feedback on the quotes and emergent themes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain Informed Movement | Experimental | Other: Pain Informed MovementThis 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 40 years of age and over
- Have a diagnosis of knee OA by a physician
- or fulfill the NICE criteria for knee OA diagnosis
- Have an average pain intensity of ≥3/10 on a numeric pain scale
Key exclusion criteria (6 listed)
- Cannot communicate in English
- Have inflammatory arthritis or other systemic conditions
- Have had lower limb trauma
- Had surgery within the past 6-month, have participated in a similar knee OA exercise program in the prior 3-months
- Have used oral corticosteroids or had a corticosteroid injection in the index knee within 6-months prior to baseline assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Informed MovementParticipants will attend a twice weekly exercise program. | Other | Pain Informed Movement |
Primary outcome
Acceptability of Content
Time frame: 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.
Acceptability of Frequency
Time frame: 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.
Acceptability of Duration
Time frame: 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.
Burden of Questionnaires
Time frame: 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
Burden of Physical Tests
Time frame: 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.
Recruitment Rate
Time frame: 8 weeks
Number of eligible participants who consent to participate in 1 month.
Follow-Up Rate
Time frame: 8 weeks
Percentage of participants who follow-up at 8 weeks.
Self Reported Adverse Events
Time frame: 8 weeks
Percentage of participants who did not experience any adverse events or only mild transient.
Exercise Completion
Time frame: 8 weeks
Percentage of participants who report exercising at least 3 times a week.
Adherence
Time frame: 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.
Recommending the Program
Time frame: 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).
Using the Treatment Again
Time frame: 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).
12 secondary outcomes
Change in Pain Modulation
Time frame: Baseline, 8 weeks
Change in Pain Intensity - Past 24 Hours
Time frame: Baseline, 8 weeks
Change in Function
Time frame: 8 weeks
Change in Brain-derived Neurotrophic Factor
Time frame: 8 weeks
Change in Pain Catastrophizing
Time frame: 8 weeks
Change in Chronic Pain Self-efficacy
Time frame: 8 weeks
Change in Physical Performance Tests
Time frame: 8 weeks
Change in Anxiety and Depression
Time frame: 8 weeks
Change in Perspectives on Knee Replacement Surgery 1
Time frame: 8 weeks
Change in Perspectives on Knee Replacement Surgery 2
Time frame: 8 weeks
Change in Perspectives on Knee Replacement Surgery 3
Time frame: 8 weeks
Change in Pain
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26405113Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24.
- Background: PubMed 31278997Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
- Background: PubMed 27913870Cheung C, Wyman JF, Bronas U, McCarthy T, Rudser K, Mathiason MA. Managing knee osteoarthritis with yoga or aerobic/strengthening exercise programs in older adults: a pilot randomized controlled trial. Rheumatol Int. 2017 Mar;37(3):389-398. doi: 10.1007/s00296-016-3620-2. Epub 2016 Dec 2.
- Background: PubMed 24399456Simao AP, Mendonca VA, de Oliveira Almeida TM, Santos SA, Gomes WF, Coimbra CC, Lacerda AC. Involvement of BDNF in knee osteoarthritis: the relationship with inflammation and clinical parameters. Rheumatol Int. 2014 Aug;34(8):1153-7. doi: 10.1007/s00296-013-2943-5. Epub 2014 Jan 9.
- Background: PubMed 25049144Stoppiello LA, Mapp PI, Wilson D, Hill R, Scammell BE, Walsh DA. Structural associations of symptomatic knee osteoarthritis. Arthritis Rheumatol. 2014 Nov;66(11):3018-27. doi: 10.1002/art.38778.
- Background: PubMed 25519921Nijs J, Meeus M, Versijpt J, Moens M, Bos I, Knaepen K, Meeusen R. Brain-derived neurotrophic factor as a driving force behind neuroplasticity in neuropathic and central sensitization pain: a new therapeutic target? Expert Opin Ther Targets. 2015 Apr;19(4):565-76. doi: 10.1517/14728222.2014.994506. Epub 2014 Dec 18.
- Background: PubMed 31908163Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.
- Background: PubMed 29769416Da Silva Santos R, Galdino G. Endogenous systems involved in exercise-induced analgesia. J Physiol Pharmacol. 2018 Feb;69(1):3-13. doi: 10.26402/jpp.2018.1.01. Epub 2018 May 8.
- Background: PubMed 24977916Galdino G, Romero T, Pinho da Silva JF, Aguiar D, de Paula AM, Cruz J, Parrella C, Piscitelli F, Duarte I, Di Marzo V, Perez A. Acute resistance exercise induces antinociception by activation of the endocannabinoid system in rats. Anesth Analg. 2014 Sep;119(3):702-715. doi: 10.1213/ANE.0000000000000340.
- Background: PubMed 9562159Koltyn KF, Arbogast RW. Perception of pain after resistance exercise. Br J Sports Med. 1998 Mar;32(1):20-4. doi: 10.1136/bjsm.32.1.20.
- Background: PubMed 21956792Esser S, Bailey A. Effects of exercise and physical activity on knee osteoarthritis. Curr Pain Headache Rep. 2011 Dec;15(6):423-30. doi: 10.1007/s11916-011-0225-z.
- Background: PubMed 23717763Ghasemi GA, Golkar A, Marandi SM. Effects of hata yoga on knee osteoarthritis. Int J Prev Med. 2013 Apr;4(Suppl 1):S133-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Carlesso, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Informed Movement in people with Knee Osteoarthritis, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Content (time frame: 8 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04954586, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.