Self-regulation training for people with knee osteoarthritis: a protocol for a feasibility randomised control trial (MiNT trial)
IntroductionKnee osteoarthritis (OA) is a chronic secondary musculoskeletal pain condition resulting in disability, reduced quality of life, and high societal costs. Pain associated with knee OA is linked to increased sensitivity in sensory, cognitive, and emotional areas of the brain. Self-regulati...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2024-01-01
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| Series: | Frontiers in Pain Research |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpain.2023.1271839/full |
| _version_ | 1797359369659088896 |
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| author | Ramakrishnan Mani Divya Bharatkumar Adhia Sharon Awatere Sharon Awatere Andrew Robert Gray Jerin Mathew Luke Charles Wilson Amanda Still David Jackson Ben Hudson Fadel Zeidan Roger Fillingim Dirk De Ridder |
| author_facet | Ramakrishnan Mani Divya Bharatkumar Adhia Sharon Awatere Sharon Awatere Andrew Robert Gray Jerin Mathew Luke Charles Wilson Amanda Still David Jackson Ben Hudson Fadel Zeidan Roger Fillingim Dirk De Ridder |
| author_sort | Ramakrishnan Mani |
| collection | DOAJ |
| description | IntroductionKnee osteoarthritis (OA) is a chronic secondary musculoskeletal pain condition resulting in disability, reduced quality of life, and high societal costs. Pain associated with knee OA is linked to increased sensitivity in sensory, cognitive, and emotional areas of the brain. Self-regulation training targeting brain functioning related to pain experience could reduce pain and its associated disability. Self-regulatory treatments such as mindfulness meditation (MM) and electroencephalography neurofeedback (EEG-NF) training improve clinical outcomes in people with knee OA. A feasibility clinical trial can address factors that could inform the design of the full trial investigating the effectiveness of self-regulation training programmes in people with knee OA. This clinical trial will evaluate the feasibility, safety, acceptability, experience and perceptions of the self-regulatory training programmes.MethodsThe proposed feasibility trial is based on a double-blind (outcome assessor and investigators), three-arm (MM usual care, EEG-NF + usual care and usual care control group) randomised controlled parallel clinical trial. Participants with knee OA will be recruited from the community and healthcare practices. A research assistant (RA) will administer both interventions (20-min sessions, four sessions each week, and 12 sessions over three successive weeks). Feasibility measures (participant recruitment rate, adherence to interventions, retention rate), safety, and acceptability of interventions will be recorded. An RA blinded to the group allocation will record secondary outcomes at baseline, immediately post-intervention (4th week), and 3 months post-intervention. The quantitative outcome measures will be descriptively summarised. The qualitative interviews will evaluate the participants' experiences and perceptions regarding various aspects of the trial, which includes identifying the barriers and facilitators in participating in the trial, evaluating their opinions on the research procedures, such as their preferences for the study site, and determining the level of acceptability of the interventions as potential clinical treatments for managing knee OA. Māori participant perceptions of how assessment and training practices could be acceptable to a Māori worldview will be explored. The interviews will be audio-recorded and analysed thematically.DiscussionThis trial will provide evidence on the feasibility, safety, and acceptability of the MM and EEG-NF training in people with knee OA, thus informing the design of a full randomised clinical control trial. |
| first_indexed | 2024-03-08T15:16:36Z |
| format | Article |
| id | doaj.art-c54193811ba445c4a30311734e877e99 |
| institution | Directory Open Access Journal |
| issn | 2673-561X |
| language | English |
| last_indexed | 2024-03-08T15:16:36Z |
| publishDate | 2024-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pain Research |
| spelling | doaj.art-c54193811ba445c4a30311734e877e992024-01-10T11:30:18ZengFrontiers Media S.A.Frontiers in Pain Research2673-561X2024-01-01410.3389/fpain.2023.12718391271839Self-regulation training for people with knee osteoarthritis: a protocol for a feasibility randomised control trial (MiNT trial)Ramakrishnan Mani0Divya Bharatkumar Adhia1Sharon Awatere2Sharon Awatere3Andrew Robert Gray4Jerin Mathew5Luke Charles Wilson6Amanda Still7David Jackson8Ben Hudson9Fadel Zeidan10Roger Fillingim11Dirk De Ridder12Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New ZealandDepartment of Surgical Sciences, Otago Medical School, University of Otago, Dunedin, New ZealandCentre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New ZealandThe Health Boutique, Napier, New ZealandBiostatistics Centre, University of Otago, Dunedin, New ZealandDepartment of Anatomy, School of Biomedical Sciences, University of Otago, Dunedin, New ZealandOtago Medical School, University of Otago, Dunedin, New ZealandCentre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New ZealandCentre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New ZealandDepartment of General Practice, University of Otago, Christchurch, New ZealandDepartment of Anesthesiology, School of Medicine, University of California, San Diego, CA, United StatesPain Research and Intervention Center of Excellence, Clinical and Translational Science Institute, College of Dentistry, University of Florida, Gainesville, FL, United StatesDepartment of Surgical Sciences, Otago Medical School, University of Otago, Dunedin, New ZealandIntroductionKnee osteoarthritis (OA) is a chronic secondary musculoskeletal pain condition resulting in disability, reduced quality of life, and high societal costs. Pain associated with knee OA is linked to increased sensitivity in sensory, cognitive, and emotional areas of the brain. Self-regulation training targeting brain functioning related to pain experience could reduce pain and its associated disability. Self-regulatory treatments such as mindfulness meditation (MM) and electroencephalography neurofeedback (EEG-NF) training improve clinical outcomes in people with knee OA. A feasibility clinical trial can address factors that could inform the design of the full trial investigating the effectiveness of self-regulation training programmes in people with knee OA. This clinical trial will evaluate the feasibility, safety, acceptability, experience and perceptions of the self-regulatory training programmes.MethodsThe proposed feasibility trial is based on a double-blind (outcome assessor and investigators), three-arm (MM usual care, EEG-NF + usual care and usual care control group) randomised controlled parallel clinical trial. Participants with knee OA will be recruited from the community and healthcare practices. A research assistant (RA) will administer both interventions (20-min sessions, four sessions each week, and 12 sessions over three successive weeks). Feasibility measures (participant recruitment rate, adherence to interventions, retention rate), safety, and acceptability of interventions will be recorded. An RA blinded to the group allocation will record secondary outcomes at baseline, immediately post-intervention (4th week), and 3 months post-intervention. The quantitative outcome measures will be descriptively summarised. The qualitative interviews will evaluate the participants' experiences and perceptions regarding various aspects of the trial, which includes identifying the barriers and facilitators in participating in the trial, evaluating their opinions on the research procedures, such as their preferences for the study site, and determining the level of acceptability of the interventions as potential clinical treatments for managing knee OA. Māori participant perceptions of how assessment and training practices could be acceptable to a Māori worldview will be explored. The interviews will be audio-recorded and analysed thematically.DiscussionThis trial will provide evidence on the feasibility, safety, and acceptability of the MM and EEG-NF training in people with knee OA, thus informing the design of a full randomised clinical control trial.https://www.frontiersin.org/articles/10.3389/fpain.2023.1271839/fullchronic painmusculoskeletal painmindfulness meditation (MM)mindfulness—pain interventionneurofeedback (NF)self-regulation training |
| spellingShingle | Ramakrishnan Mani Divya Bharatkumar Adhia Sharon Awatere Sharon Awatere Andrew Robert Gray Jerin Mathew Luke Charles Wilson Amanda Still David Jackson Ben Hudson Fadel Zeidan Roger Fillingim Dirk De Ridder Self-regulation training for people with knee osteoarthritis: a protocol for a feasibility randomised control trial (MiNT trial) Frontiers in Pain Research chronic pain musculoskeletal pain mindfulness meditation (MM) mindfulness—pain intervention neurofeedback (NF) self-regulation training |
| title | Self-regulation training for people with knee osteoarthritis: a protocol for a feasibility randomised control trial (MiNT trial) |
| title_full | Self-regulation training for people with knee osteoarthritis: a protocol for a feasibility randomised control trial (MiNT trial) |
| title_fullStr | Self-regulation training for people with knee osteoarthritis: a protocol for a feasibility randomised control trial (MiNT trial) |
| title_full_unstemmed | Self-regulation training for people with knee osteoarthritis: a protocol for a feasibility randomised control trial (MiNT trial) |
| title_short | Self-regulation training for people with knee osteoarthritis: a protocol for a feasibility randomised control trial (MiNT trial) |
| title_sort | self regulation training for people with knee osteoarthritis a protocol for a feasibility randomised control trial mint trial |
| topic | chronic pain musculoskeletal pain mindfulness meditation (MM) mindfulness—pain intervention neurofeedback (NF) self-regulation training |
| url | https://www.frontiersin.org/articles/10.3389/fpain.2023.1271839/full |
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