A Multidisciplinary Intervention in Total Knee Arthroplasty
NCT ID: NCT03771430
Last Updated: 2023-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
282 participants
INTERVENTIONAL
2019-08-28
2024-12-31
Brief Summary
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Detailed Description
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Pilot/Feasibility study:
The study will include a feasibility/pilot study with 15 patients to be performed from November 2018. The intervention and study procedures may be modified based on results from the feasibility/pilot study.
Full scale Randomized Controlled Trial (RCT):
The full-scale RCT will include 282 patients scheduled for TKA. Patients will be randomly assigned to one of three groups: 1) non-surgical intervention (i.e., PT+CBT), 2) a combination of TKA with pre- and postoperative PT+CBT, or 3) A control group receiving TKA and usual care follow-up. Primary outcome: The Pain subscale from the KOOS. The intervention has the potential to improve outcomes for patients who currently obtain little benefit from standard TKA.
Cross-sectional observational study: Patients declining to participate in the RCT will be offered the option to participate in a separate cross-sectional study. The inclusion and exclusion criteria will be identical to the RCT. Patients who agree to participate in the cross-sectional study will complete the same baseline questionnaires as in the RCT and are asked about the reasons they did not want to participate in the RCT.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Non-surgical group
Osteoarthritis education, exercise and eCBT
Osteoarthritis education, exercise and CBT
Osteoarthritis Education
1. 60-min session by AktivA trained PT)
* Signs/symptoms, risk factors, weight control, treatment
* Importance of physical activity
* Appropriate activity \& training modalities
Exercise and CBT Support
2. 60-min sessions/week for 12 weeks (a total of 24 sessions) led by AktivA and CBT trained PT)
* Warm-up session
* Strengthening exercises
* Functional exercises
* Stretching
* Monitoring of CBT progress
* Review of CBT lessons learned
* Integration of CBT skills
* Enhance motivation to continue
Online CBT (iCBT) (10 modules completed at home)
* Pain causes \& prevention
* Pain management
* Health promotion \& stress reduction at home \& work
* Adapting for leisure \& work
* Controlling flare-ups
* Maintaining \& improving results
Combined group
Total knee arthroplasty + osteoarthritis education, exercise and eCBT
Osteoarthritis education, exercise and CBT
Osteoarthritis Education
1. 60-min session by AktivA trained PT)
* Signs/symptoms, risk factors, weight control, treatment
* Importance of physical activity
* Appropriate activity \& training modalities
Exercise and CBT Support
2. 60-min sessions/week for 12 weeks (a total of 24 sessions) led by AktivA and CBT trained PT)
* Warm-up session
* Strengthening exercises
* Functional exercises
* Stretching
* Monitoring of CBT progress
* Review of CBT lessons learned
* Integration of CBT skills
* Enhance motivation to continue
Online CBT (iCBT) (10 modules completed at home)
* Pain causes \& prevention
* Pain management
* Health promotion \& stress reduction at home \& work
* Adapting for leisure \& work
* Controlling flare-ups
* Maintaining \& improving results
Total Knee Arthroplasty
Standard total knee arthroplasty will be performed.
Surgery only (standard care)
Total knee arthroplasty + standard physiotherapy
Total Knee Arthroplasty
Standard total knee arthroplasty will be performed.
Interventions
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Osteoarthritis education, exercise and CBT
Osteoarthritis Education
1. 60-min session by AktivA trained PT)
* Signs/symptoms, risk factors, weight control, treatment
* Importance of physical activity
* Appropriate activity \& training modalities
Exercise and CBT Support
2. 60-min sessions/week for 12 weeks (a total of 24 sessions) led by AktivA and CBT trained PT)
* Warm-up session
* Strengthening exercises
* Functional exercises
* Stretching
* Monitoring of CBT progress
* Review of CBT lessons learned
* Integration of CBT skills
* Enhance motivation to continue
Online CBT (iCBT) (10 modules completed at home)
* Pain causes \& prevention
* Pain management
* Health promotion \& stress reduction at home \& work
* Adapting for leisure \& work
* Controlling flare-ups
* Maintaining \& improving results
Total Knee Arthroplasty
Standard total knee arthroplasty will be performed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 18 - 79 years
3. ASA grade 1-3
4. KL grade 3 or 4
5. BMI\<40
6. Able to read and write in Norwegian
Exclusion Criteria
* Previously undergone uni or patellofemoral prosthesis in the index knee
* Large axis deviation or instability requiring use of hinged implants
* Scheduled for unicompartmental arthroplasty or revision surgery
18 Years
79 Years
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
Martina Hansen's Hospital
OTHER
Lovisenberg Diakonale Hospital
OTHER
Responsible Party
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Principal Investigators
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Anners Lerdal, PhD
Role: PRINCIPAL_INVESTIGATOR
Lovisenberg Diaconal Hospital, University of Oslo
Arild Aamodt, PhD
Role: PRINCIPAL_INVESTIGATOR
Lovisenberg Diakonale Hospital
Maren F Lindberg, PhD
Role: STUDY_DIRECTOR
Lovisenberg Diakonale Hospital/University of Oslo
Kari Indrekvam, PhD
Role: STUDY_CHAIR
Haukeland University Hospital - Kysthospitalet Hagevik/University of Bergen
Stig Heir, PhD
Role: STUDY_CHAIR
Martina Hansens Hospital
Locations
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Haukeland University Hospital - Kysthospitalet Hagevik
Bergen, , Norway
Lovisenberg Diaconal Hospital
Oslo, , Norway
Martina Hansens Hospital
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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Stig Heir, PhD
Role: primary
References
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Rognsvag T, Bergvad IB, Furnes O, Indrekvam K, Lerdal A, Lindberg MF, Skou ST, Stubberud J, Badawy M. Exercise therapy, education, and cognitive behavioral therapy alone, or in combination with total knee arthroplasty, in patients with knee osteoarthritis: a randomized feasibility study. Pilot Feasibility Stud. 2024 Feb 28;10(1):43. doi: 10.1186/s40814-024-01470-y.
Lindberg MF, Aamodt A, Badawy M, Bergvad IB, Borchgrevink P, Furnes O, Gay C, Heir S, Holm I, Indrekvam K, Kise N, Lau B, Magnussen J, Nerhus TK, Rognsvag T, Rudsengen DE, Rustoen T, Skou ST, Stubberud J, Smastuen MS, Lerdal A. The effectiveness of exercise therapy and education plus cognitive behavioral therapy, alone or in combination with total knee arthroplasty in patients with knee osteoarthritis - study protocol for the MultiKnee trial. BMC Musculoskelet Disord. 2021 Dec 20;22(1):1054. doi: 10.1186/s12891-021-04924-z.
Rognsvag T, Lindberg MF, Lerdal A, Stubberud J, Furnes O, Holm I, Indrekvam K, Lau B, Rudsengen D, Skou ST, Badawy M. Development of an internet-delivered cognitive behavioral therapy program for use in combination with exercise therapy and education by patients at increased risk of chronic pain following total knee arthroplasty. BMC Health Serv Res. 2021 Oct 25;21(1):1151. doi: 10.1186/s12913-021-07177-7.
Other Identifiers
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MultiKnee Trial
Identifier Type: -
Identifier Source: org_study_id
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