Clinical trial NCT03771430: A Multidisciplinary Intervention in Total Knee Arthroplasty
Official title: A Multidisciplinary Intervention in Total Knee Arthroplasty - a Multicenter, Randomized Controlled Trial in OA Patients (The MultiKnee Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis; Primary
Degenerative Joint Disease of Knee
Keywords: Total knee arthroplasty
Physiotherapy
Cognitive behavioral therapy
e-therapy
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: Martina Hansen's Hospital
First posted: 2018-12-11
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effectiveness of cognitive behavioral therapy delivered as an e-therapy program, combined with physical exercise delivered by physiotherapists, for patients on waiting list for total knee arthroplasty. The patients will be randomized to either 1) a non-surgical program consisting of web-based cognitive behavioral therapy combined with physiotherapy, 2) total knee arthroplasty (TKA) surgery followed by web-based cognitive behavioral therapy combined with physiotherapy, or 3) a control group who undergo TKA followed by standard physiotherapy.

Detailed description: The study is a multidisciplinary trial testing an intervention delivered by physiotherapists. Up to 20% of total knee arthroplasty (TKA) patients continue to experience moderate/severe pain 12 months after TKA. While physical therapy (PT) and cognitive-behavior therapy (CBT) have shown promise for improving outcomes, they have not been evaluated in combination or in patients at risk for chronic pain after TKA. This trial will evaluate PT+CBT combined, either as a substitute for or as a supplement to TKA for patients at risk for chronic pain after TKA.

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.

Eligibility criteria: Inclusion Criteria:

1. Scheduled for TKA for OA at Lovisenberg, Oslo; Martina Hansen, Bærum, or Coastal Hospital Hagevik, Bergen
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:

* Diagnosis of dementia or sero-positive rheumatic disease
* 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

Primary outcomes:
measure: Change in the knee injury and osteoarthritis score (KOOS) pain subscale
timeFrame: Before randomization, 12 months after treatment start. Also measured at 3, 6, and 24 months after treatment start.12 months after treatment start will be the primary outcome.
Secondary outcomes:
measure: Knee injury and osteoarthritis score (KOOS) subscores: Other symptoms, activities of daily living (ADL), function in sport and recreation, and knee-related quality of life (QOL)
timeFrame: Before randomization. 3, 6, 12 and 24 months following treatment start
measure: The 30 second sit to stand test
timeFrame: Before treatment start. 3, 6, 12 and 24 months following treatment start
measure: Brief Pain inventory
timeFrame: Before randomization. 3, 6, 12 and 24 months following treatment start
measure: EuroQol-5D-5L
timeFrame: Before randomization. 3, 6, 12 and 24 months following treatment start
measure: The Forgotten Joint Score
timeFrame: Before randomization. 3, 6, 12 and 24 months following treatment start
measure: Pain Catastrophizing Scale
timeFrame: Before randomization. 3, 6, 12 and 24 months following treatment start
measure: Patient-acceptable symptom state, perceived treatment failure.
timeFrame: At 3, 6, 12 and 24 months following treatment start.
measure: Global perceived effect
timeFrame: At 3, 6, 12 and 24 months following treatment start.
measure: Adverse events/serious adverse events
timeFrame: From treatment start until 24 months following treatment start.
Other outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Before randomization. 3, 6, 12 and 24 months following treatment start
measure: The Hospital Anxiety and Depression Scale
timeFrame: Before randomization. 3, 6, 12 and 24 months following treatment start
measure: The Fear-Avoidance Belief Questionnaire
timeFrame: Before randomization. 3, 6, 12 and 24 months following treatment start
measure: Health Locus of Control Scale
timeFrame: Before randomization. 3, 12 and 24 months following treatment start
measure: Self-reported level of physical activity
timeFrame: Before randomization. 3, 6, 12 and 24 months following treatment start
measure: The ActiGraph Professional single-axis accelerometer
timeFrame: Before treatment start. 6, 12 and 24 months following treatment start
measure: The 40 meters walk test
timeFrame: Before treatment start. 3, 6, 12 and 24 months following treatment start
measure: Stair Climb Test
timeFrame: Before treatment start. 3, 6, 12 and 24 months following treatment start
measure: Registry-based data on use of health care resources
timeFrame: From before randomization until 3, 6, 12 and 24 months after treatment start.
measure: Radiographs: weightbearing AP, lateral view, Rosenberg view and long leg weightbearing AP view (HKA)
timeFrame: Before treatment start, 12 months following treatment start.
measure: Screening and recruitment of patients (pilot study with 15 patients).
timeFrame: Baseline T1 before randomization
measure: Adherence to the intervention (pilot study with 15 patients)
timeFrame: From treatment start until 12 weeks following treatment start.
measure: Acceptability of the intervention (pilot study with 15 patients)
timeFrame: From treatment start until 12 weeks following treatment start.
measure: Level of electronic health literacy
timeFrame: Before treatment start, 6 months after treatment start
measure: Level of health literacy
timeFrame: Before treatment start, 6 months after treatment start
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital - Kysthospitalet Hagevik
city: Oslo
country: Norway
facility: Lovisenberg Diaconal Hospital
city: Oslo
country: Norway
facility: Martina Hansens Hospital
Study officials:
affiliation: Lovisenberg Diaconal Hospital, University of Oslo
name: Anners Lerdal, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lovisenberg Diakonale Hospital
name: Arild Aamodt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lovisenberg Diakonale Hospital/University of Oslo
name: Maren F Lindberg, PhD
role: STUDY_DIRECTOR
affiliation: Haukeland University Hospital - Kysthospitalet Hagevik/University of Bergen
name: Kari Indrekvam, PhD
role: STUDY_CHAIR
affiliation: Martina Hansens Hospital
name: Stig Heir, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.