Feasibility of Pain Informed Movement for Knee OA

NCT04954586 | Completed Results

• 1 other identifier: Pain Informed Movement
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Knee Osteoarthritis

Keywords

Pain Management; Pain Modulation; Yoga; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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

  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.

  8 weeks

• Recruitment Rate

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

  8 weeks

• Follow-Up Rate

  Percentage of participants who follow-up at 8 weeks.

  8 weeks

• Self Reported Adverse Events

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

  8 weeks

• Exercise Completion

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

  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.

  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).

  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).

  8 weeks

Secondary Outcomes (12)

• Change in Pain Modulation

  Baseline, 8 weeks

• Change in Pain Intensity - Past 24 Hours

  Baseline, 8 weeks

• Change in Function

  8 weeks

• Change in Brain-derived Neurotrophic Factor

  8 weeks

• Change in Pain Catastrophizing

  8 weeks

Study Arms (1)

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.

Other: Pain Informed Movement

Interventions

Pain Informed Movement OTHER

Participants will attend a twice weekly exercise program.

Pain Informed Movement

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• The Arthritis Society, Canada: collaborator

Study Sites (1)

PACE, McMaster University

Hamilton, Ontario, L8S 1C7, Canada

Location

Related Publications (21)

• 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.

  PMID: 26405113 BACKGROUND

• Bannuru 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.

  PMID: 31278997 BACKGROUND

• Cheung 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.

  PMID: 27913870 BACKGROUND

• Simao 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.

  PMID: 24399456 BACKGROUND

• Stoppiello 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.

  PMID: 25049144 BACKGROUND

• Nijs 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.

  PMID: 25519921 BACKGROUND

• Kolasinski 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.

  PMID: 31908163 BACKGROUND

• Da 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.

  PMID: 29769416 BACKGROUND

• Galdino 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.

  PMID: 24977916 BACKGROUND

• Koltyn 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.

  PMID: 9562159 BACKGROUND

• Esser 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.

  PMID: 21956792 BACKGROUND

• Ghasemi GA, Golkar A, Marandi SM. Effects of hata yoga on knee osteoarthritis. Int J Prev Med. 2013 Apr;4(Suppl 1):S133-8.

  PMID: 23717763 BACKGROUND

• Merighi 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.

  PMID: 18514997 BACKGROUND

• Obata 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.

  PMID: 16516994 BACKGROUND

• Binder DK, Scharfman HE. Brain-derived neurotrophic factor. Growth Factors. 2004 Sep;22(3):123-31. doi: 10.1080/08977190410001723308.

  PMID: 15518235 BACKGROUND

• Ritter AM, Lewin GR, Kremer NE, Mendell LM. Requirement for nerve growth factor in the development of myelinated nociceptors in vivo. Nature. 1991 Apr 11;350(6318):500-2. doi: 10.1038/350500a0.

  PMID: 2014050 BACKGROUND

• Snider WD. Functions of the neurotrophins during nervous system development: what the knockouts are teaching us. Cell. 1994 Jun 3;77(5):627-38. doi: 10.1016/0092-8674(94)90048-5. No abstract available.

  PMID: 8205613 BACKGROUND

• Woolf CJ, Safieh-Garabedian B, Ma QP, Crilly P, Winter J. Nerve growth factor contributes to the generation of inflammatory sensory hypersensitivity. Neuroscience. 1994 Sep;62(2):327-31. doi: 10.1016/0306-4522(94)90366-2.

  PMID: 7530342 BACKGROUND

• Nicol GD, Vasko MR. Unraveling the story of NGF-mediated sensitization of nociceptive sensory neurons: ON or OFF the Trks? Mol Interv. 2007 Feb;7(1):26-41. doi: 10.1124/mi.7.1.6.

  PMID: 17339604 BACKGROUND

• McKelvey L, Shorten GD, O'Keeffe GW. Nerve growth factor-mediated regulation of pain signalling and proposed new intervention strategies in clinical pain management. J Neurochem. 2013 Feb;124(3):276-89. doi: 10.1111/jnc.12093.

  PMID: 23157347 BACKGROUND

• Miller RE, Malfait AM, Block JA. Current status of nerve growth factor antibodies for the treatment of osteoarthritis pain. Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 107(5):85-87. Epub 2017 Sep 28.

  PMID: 28967370 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Agnosia

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Modification of inclusion criteria needed for future pilot RCT to enhance recruitment process.

Results Point of Contact

• Title: Dr. Lisa Carlesso
• Organization: McMaster University

carlesl@mcmaster.ca

9055259140

Study Officials

• Lisa Carlesso, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: July 8, 2021
• Study Start: May 4, 2022
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: October 3, 2024
• Results First Posted: October 3, 2024

Record last verified: 2024-07

Locations

CA (1)