Pain Informed Movement for People With Knee Osteoarthritis

NCT05730829 | Completed Results

• 1 other identifier: HiREB 15700
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare a pain informed movement program to standard neuromuscular exercise in people with knee osteoarthritis. The main question it aims to answer are:

1. 1.Are the two interventions a) pain informed movement program plus pain neuroscience education and b) neuromuscular exercise plus standard osteoarthritis education feasible in terms of recruitment, treatment adherence, timelines, data collection procedures, patient follow-up, and resources required?
2. 2.Is there a difference in patient's satisfaction and acceptability of the two programs?
3. 3.Are there any differences in the potential effects of the two programs on subjective pain measures, self-reported function, quality of life, functional leg strength, nervous system pain modulation, brain derived neurotrophic factor and nerve growth factor levels, and psychological factors?

Conditions

Knee Osteoarthritis

Keywords

pain modulation; mind-body exercise

Outcome Measures

Primary Outcomes (1)

• Percentage of Follow up

  The follow-up rate is calculated as the number (percentage) of participants who completed the study out of those who completed the baseline assessment.

  8 weeks

Secondary Outcomes (7)

• Number of Participants Who Considered the Program Useful and Very Useful

  8 weeks

• Number of Participants Who Considered the Program Frequent Enough

  8 weeks

• Number of Participants Who Considered the Educational Session Frequency Enough

  8 weeks

• Rate of Recruitment Measured by Number of People Recruited in a Year

  1 year

• Percentage of Participants Who Did Not Find the Study Procedures Burdensome (Questionnaires, Tests, Blood Draws) Measured on 0-10 Scale

  8 weeks

Other Outcomes (19)

• Modified Charlson Comorbidity Index

  baseline

• Participant Characteristics

  baseline

• Weight

  baseline and 8 weeks

Study Arms (2)

Pain Informed Movement and pain neuroscience education

EXPERIMENTAL

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.

Other: pain informed movement; Other: Pain Neuroscience Education (PNE)

Standard neuromuscular exercise and OA education

ACTIVE COMPARATOR

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.

Other: standard neuromuscular exercise; Other: Standard osteoarthritis (OA) education

Interventions

pain informed movement OTHER

group classes twice weekly for 8 weeks of neuromuscular exercise in combination with mind-body techniques such as breath regulation, muscle tension regulation, relaxation, mindfulness, awareness of pain related thoughts and emotions.

Pain Informed Movement and pain neuroscience education

standard neuromuscular exercise OTHER

group classes twice weekly for 8 weeks of neuromuscular exercise.

Standard neuromuscular exercise and OA education

Pain Neuroscience Education (PNE) OTHER

The pain neuroscience education (PNE) will be delivered in videos addressing concepts such as 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.

Pain Informed Movement and pain neuroscience education

Standard osteoarthritis (OA) education OTHER

The standard osteoarthritis (OA) education will address the following topics, OA prevalence, risk factors, symptoms, diagnosis, treatment, role of exercise, surgery, self-management

Standard neuromuscular exercise and OA education

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- ≥40 years of age with diagnosis of knee osteoarthritis (OA) by a physician OR;
• ≥45 years of age and having activity-related knee joint pain with or without morning stiffness lasting 30 minutes (NICE criteria)
• Having an average pain intensity of 3/10 on a numeric pain scale on most days of the past month

You may not qualify if:

• Cannot communicate in English;
• Has inflammatory arthritis or other systemic conditions;
• Have had lower limb trauma or surgery within the past 6 months;
• Have participated in a knee OA exercise program in the prior 3 months;
• Have had any injection in the index knee within 3-months prior to baseline assessment
• Does not have regular access to the internet
• Inability to get up and down from the floor independently
• Use of mobility aids
• Currently participating in any other drug/device/exercise clinical trial related to OA
• Planned absences (e.g., trips away) of \>1 week
• Currently receiving other forms of care for knee OA pain (e.g., from a physiotherapist, chiropractor, athletic therapist, kinesiologist)
• Does not meet screening for safe participation in exercise according to the Get Active questionnaire from the Canadian Society for Exercise Physiology

Sponsors & Collaborators

• McMaster University: lead
• Boston University: collaborator
• University of Melbourne: collaborator
• University of British Columbia: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S1C7, Canada

Location

Related Publications (25)

• Fingleton C, Smart K, Moloney N, Fullen BM, Doody C. Pain sensitization in people with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2015 Jul;23(7):1043-56. doi: 10.1016/j.joca.2015.02.163. Epub 2015 Mar 5.

  PMID: 25749012 BACKGROUND

• Carlesso LC, Segal NA, Frey-Law L, Zhang Y, Na L, Nevitt M, Lewis CE, Neogi T. Pain Susceptibility Phenotypes in Those Free of Knee Pain With or at Risk of Knee Osteoarthritis: The Multicenter Osteoarthritis Study. Arthritis Rheumatol. 2019 Apr;71(4):542-549. doi: 10.1002/art.40752. Epub 2019 Feb 7.

  PMID: 30307131 BACKGROUND

• Neogi T, Frey-Law L, Scholz J, Niu J, Arendt-Nielsen L, Woolf C, Nevitt M, Bradley L, Felson DT; Multicenter Osteoarthritis (MOST) Study. Sensitivity and sensitisation in relation to pain severity in knee osteoarthritis: trait or state? Ann Rheum Dis. 2015 Apr;74(4):682-8. doi: 10.1136/annrheumdis-2013-204191. Epub 2013 Dec 18.

  PMID: 24351516 BACKGROUND

• Petersen KK, Graven-Nielsen T, Simonsen O, Laursen MB, Arendt-Nielsen L. Preoperative pain mechanisms assessed by cuff algometry are associated with chronic postoperative pain relief after total knee replacement. Pain. 2016 Jul;157(7):1400-1406. doi: 10.1097/j.pain.0000000000000531.

  PMID: 27331347 BACKGROUND

• 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

• Anwer S, Alghadir A, Brismee JM. Effect of Home Exercise Program in Patients With Knee Osteoarthritis: A Systematic Review and Meta-analysis. J Geriatr Phys Ther. 2016 Jan-Mar;39(1):38-48. doi: 10.1519/JPT.0000000000000045.

  PMID: 25695471 BACKGROUND

• Rice D, McNair P, Huysmans E, Letzen J, Finan P. Best Evidence Rehabilitation for Chronic Pain Part 5: Osteoarthritis. J Clin Med. 2019 Oct 24;8(11):1769. doi: 10.3390/jcm8111769.

  PMID: 31652929 BACKGROUND

• Yarnitsky D. Role of endogenous pain modulation in chronic pain mechanisms and treatment. Pain. 2015 Apr;156 Suppl 1:S24-S31. doi: 10.1097/01.j.pain.0000460343.46847.58.

  PMID: 25789433 BACKGROUND

• Damien J, Colloca L, Bellei-Rodriguez CE, Marchand S. Pain Modulation: From Conditioned Pain Modulation to Placebo and Nocebo Effects in Experimental and Clinical Pain. Int Rev Neurobiol. 2018;139:255-296. doi: 10.1016/bs.irn.2018.07.024. Epub 2018 Aug 14.

  PMID: 30146050 BACKGROUND

• Hassed C. Mind-body therapies--use in chronic pain management. Aust Fam Physician. 2013 Mar;42(3):112-7.

  PMID: 23529519 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 Care Res (Hoboken). 2020 Feb;72(2):149-162. doi: 10.1002/acr.24131. Epub 2020 Jan 6.

  PMID: 31908149 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

• Pearson N, Prosko S, Sullivan M, Taylor MJ. White Paper: Yoga Therapy and Pain-How Yoga Therapy Serves in Comprehensive Integrative Pain Management, and How It Can Do More. Int J Yoga Therap. 2020 Jan 1;30(1):117-133. doi: 10.17761/2020-D-19-00074.

  PMID: 32412808 BACKGROUND

• Busch V, Magerl W, Kern U, Haas J, Hajak G, Eichhammer P. The effect of deep and slow breathing on pain perception, autonomic activity, and mood processing--an experimental study. Pain Med. 2012 Feb;13(2):215-28. doi: 10.1111/j.1526-4637.2011.01243.x. Epub 2011 Sep 21.

  PMID: 21939499 BACKGROUND

• Ma X, Yue ZQ, Gong ZQ, Zhang H, Duan NY, Shi YT, Wei GX, Li YF. The Effect of Diaphragmatic Breathing on Attention, Negative Affect and Stress in Healthy Adults. Front Psychol. 2017 Jun 6;8:874. doi: 10.3389/fpsyg.2017.00874. eCollection 2017.

  PMID: 28626434 BACKGROUND

• Russo MA, Santarelli DM, O'Rourke D. The physiological effects of slow breathing in the healthy human. Breathe (Sheff). 2017 Dec;13(4):298-309. doi: 10.1183/20734735.009817.

  PMID: 29209423 BACKGROUND

• Schlereth T, Birklein F. The sympathetic nervous system and pain. Neuromolecular Med. 2008;10(3):141-7. doi: 10.1007/s12017-007-8018-6. Epub 2007 Nov 8.

  PMID: 17990126 BACKGROUND

• Majeed MH, Ali AA, Sudak DM. Mindfulness-based interventions for chronic pain: Evidence and applications. Asian J Psychiatr. 2018 Feb;32:79-83. doi: 10.1016/j.ajp.2017.11.025. Epub 2017 Dec 5.

  PMID: 29220782 BACKGROUND

• van Doormaal MCM, Meerhoff GA, Vliet Vlieland TPM, Peter WF. A clinical practice guideline for physical therapy in patients with hip or knee osteoarthritis. Musculoskeletal Care. 2020 Dec;18(4):575-595. doi: 10.1002/msc.1492. Epub 2020 Jul 9.

  PMID: 32643252 BACKGROUND

• Louw A, Puentedura EJ, Reed J, Zimney K, Grimm D, Landers MR. A controlled clinical trial of preoperative pain neuroscience education for patients about to undergo total knee arthroplasty. Clin Rehabil. 2019 Nov;33(11):1722-1731. doi: 10.1177/0269215519857782. Epub 2019 Jun 19.

  PMID: 31213078 BACKGROUND

• Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.

  PMID: 22133255 BACKGROUND

• Wijma AJ, van Wilgen CP, Meeus M, Nijs J. Clinical biopsychosocial physiotherapy assessment of patients with chronic pain: The first step in pain neuroscience education. Physiother Theory Pract. 2016 Jul;32(5):368-84. doi: 10.1080/09593985.2016.1194651. Epub 2016 Jun 28.

  PMID: 27351769 BACKGROUND

• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.

  PMID: 27777223 BACKGROUND

• Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.

  PMID: 23295957 BACKGROUND

• Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.

  PMID: 20053272 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Dr Lisa Carlesso
• Organization: McMaster University

carlesl@mcmaster.ca

2896805640

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 16, 2023
• Study Start: April 3, 2023
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)