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A Multidisciplinary Intervention in Total Knee Arthroplasty (MULTI-KNEE)

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ClinicalTrials.gov Identifier: NCT03771430
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Lovisenberg Diakonale Hospital

Brief Summary:
The purpose of this study is to investigate the effectiveness of an intervention consisting of cognitive behavioral therapy delivered as an e-therapy program, combined with physical exercise delivered by physiotherapists, for patients at high risk for non-improvement if they undergo 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.

Condition or disease Intervention/treatment Phase
Gonarthrosis; Primary Degenerative Joint Disease of Knee Behavioral: Group osteoarthritis education, exercise and CBT Procedure: Total Knee Arthroplasty Not Applicable

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 230 patients scheduled for TKA and identified as being at risk for chronic pain based on previously established preoperative criteria. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multidisciplinary Intervention in Total Knee Arthroplasty - a Multicenter, Randomized Controlled Trial in OA Patients (The MULTI-KNEE Trial)
Actual Study Start Date : January 24, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Non-surgical group
Group osteoarthritis education, exercise and CBT
Behavioral: Group osteoarthritis education, exercise and CBT

Group Osteoarthritis Education (3 60-min sessions over 12 weeks 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 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 (e-Therapy) (12 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
Other Name: AktivA

Experimental: Combined group
Total knee arthroplasty + Group osteoarthritis education, exercise and CBT
Behavioral: Group osteoarthritis education, exercise and CBT

Group Osteoarthritis Education (3 60-min sessions over 12 weeks 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 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 (e-Therapy) (12 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
Other Name: AktivA

Procedure: Total Knee Arthroplasty
Standard total knee arthroplasty will be performed.
Other Name: knee replacement

Active Comparator: Surgery only (standard care)
Total knee arthroplasty + standard physiotherapy
Procedure: Total Knee Arthroplasty
Standard total knee arthroplasty will be performed.
Other Name: knee replacement




Primary Outcome Measures :
  1. Change in the knee injury and osteoarthritis score (KOOS) pain subscale [ Time Frame: From baseline until 12 months after treatment start ]

    KOOS is a knee-specific, patient administered questionnaire developed to evaluate short- and long-term symptoms and functioning in subjects with knee injury and osteoarthritis. KOOS is validated for use in total knee arthroplasty and has been shown to be a valid, reliable and responsive measure. KOOS is a patient-administered questionnaire.

    The KOOS is a knee joint specific questionnaire with 42 items designed to assess patients' opinions about their difficulties with activity due to problems with their knees during the past week. The pain subscale of the KOOS consists of 9 items that assess frequency of pain and pain severity in different situations. Each of the 42 items carries equal weighting (0-4), with higher scores indicating better functioning. The pain subscale score will be transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no problems.



Secondary Outcome Measures :
  1. Knee injury and osteoarthritis score (KOOS) subscores: Pain, other symptoms, activities of daily living (ADL), function in sport and recreation, and knee-related quality of life (QOL) [ Time Frame: From before randomization until 3, 6, 12 and 24 months after treatment start. ]

    KOOS is a knee-specific questionnaire developed to evaluate short- and long-term symptoms and functioning in subjects with knee injury and osteoarthritis.

    The KOOS is a knee joint specific questionnaire with 42 items designed to assess patients' opinions about their difficulties with activity due to problems with their knees during the past week. KOOS has 5 subscales: pain, other symptoms, activities of daily living (ADL), function in sport and recreation, and knee-related QOL. The KOOS has been validated for use in TKA and has been shown to be valid, reliable and responsive. Each of the 42 items carries equal weighting (0-4), with higher scores indicating better functioning. Each of the subscale scores are transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no problems. KOOS is a patient-administered questionnaire.


  2. Brief Pain inventory [ Time Frame: From before randomization until 3, 6, 12 and 24 months after treatment start. ]
    The Brief Pain Inventory (BPI) will be used to measure pain (56). The BPI is a brief patient-completed questionnaire that consists of four items that measure pain intensity (on an 11-point numeric rating scale from 0-10), seven questions on pain interference with functioning, a body map to localize the pain and one item on pain relief.

  3. Pittsburgh Sleep Quality Index [ Time Frame: From before randomization until 3, 6, 12 and 24 months after treatment start. ]
    The Pittsburgh Sleep Quality index (PSQI) is a widely-used self-report measure of sleep disturbance during the past month. The PSQI consists of 19 items that measures different aspects of sleep. The 19 items produce 7 component scores (i.e., duration of sleep, sleep disturbance, sleep latency, day dysfunction due to sleepiness, sleep efficiency, overall sleep quality, need for sleep medications) each ranging from 0-3 where higher score indicate poorer sleep. All component scores can be summarized to a global score that range from 0 to 21 where higher scores indicate poorer sleep quality. The PSQI has good validity and reliability.

  4. Pain Catastrophizing Scale [ Time Frame: From before randomization until 3, 6, 12 and 24 months after treatment start. ]
    The Pain Catastrophizing scale (PCS) will be used to measure catastrophic thinking related to pain. The scale consist of 13 items that range from 0 -4. The PCS assesses three dimensions of catastrophizing (i.e., rumination (range 0-16), magnification (range: 0-12, helplessness (range 0 -24). Higher scores indicate higher levels of catastrophic thinking related to pain. A total score can be computed by summing responses to all 13 items. PCS total scores range from 0-52. Higher scores indicate higher levels of catastrophic thinking related to pain.

  5. Health Locus of Control Scale [ Time Frame: From before randomization until 3, 6, 12 and 24 months after treatment start. ]
    The Health Locus of Control Scale (HLCS) will be used to measure patients' anticipations between own health and disease behavior and consequences of the behavior. The scale consists of 18 statements. Patients rate their agreement on a 6 point likert scale ranging from disagrees completely to agrees completely. Scoring: The scoring system consists of 3 subscales: The Internal Locus of Control, the Powerful Others Health Locus of Control, and the Chance Health Locus of control. The scores are obtained by summing items for each subscale. Higher scores indicate stronger agreement or inclination towards that particular subscale.

  6. The Fear-Avoidance Belief Questionnaire [ Time Frame: From before randomization until 3, 6, 12 and 24 months after treatment start. ]
    The Fear-Avoidance Belief Questionnaire (FABQ) will be used to measure pain-related fear of movement. The instrument consists of 2 subscales, fear-avoidance beliefs for work, and fear-avoidance beliefs for physical activity (FABQ-PA). Only the FABQ-PA subscale will be used in this study. The FABQ-PA consists of 4 items where patients rate their agreement with 5 statements about pain and physical activity. The FABQ-PA range from 0-24 and higher scores indicate higher levels of pain-related fear of movement.

  7. The Hospital Anxiety and Depression Scale [ Time Frame: From before randomization until 3, 6, 12 and 24 months after treatment start. ]
    The Hospital Anxiety and Depression Scale (HADS) will be used to measure self-reported psychological distress (depression and anxiety). The scale consists of 14 items, 7 on the depression subscale and 7 on the anxiety subscale. The Norwegian version has excellent psychometric properties. Each subscale range from 0-21 where higher scores indicate higher levels of anxiety or depression. A total score (range 0 - 42) can be calculated from summarizing all the 14 items. Higher scores indicate higher levels of anxiety/depression.

  8. EuroQol-5D-5L [ Time Frame: From before randomization until 3, 6, 12 and 24 months after treatment start. ]

    The widely used EuroQol-5 (EQ-5D-5L) will be used to measure health-related quality of life.

    The EQ5D-5L consists of two parts: A descriptive system (Mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and the EQ-VAS that record patients self-rated health on a visual analog scale that range from 0 - 100, higher levels indicate better self-rated health.

    The descriptive system can be converted to a single summary index number where lower levels indicate poorer health-related quality of life.


  9. The Forgotten Joint Score [ Time Frame: From before randomization until 3, 6, 12 and 24 months after treatment start. ]
    The Forgotten Joint Score will be used to assess how natural the prosthesis feels after total knee arthroplasty. The scoring system consists of 12 items that assess patients agreement with 12 statements, that range from 1 (never) to 5 (mostly). The raw score is transformed to a 0-100 score and then reversed to obtain the final score. A higher score indicate better outcome.

  10. Patient-acceptable symptom state, perceived treatment failure. [ Time Frame: At 3, 6, 12 and 24 months following treatment start. ]

    Patient-acceptable symptom state will be measured by a single item question. The patient state wether they consider their knee function satisfactory or not (Yes/No).

    Perceived treatment failure will be measured by a single item question. The patient state whether their situation is so dissatisfying that they consider the treatment as a failure (Yes/No).


  11. Global perceived effect [ Time Frame: At 3, 6, 12 and 24 months following treatment start. ]

    The patient rate their level of knee problems compared to their condition before they started their treatment, by choosing on of seven statements that describe the level of improvement/worsening.

    The statements range from "better - an important improvement" - to "worse, an important worsening".


  12. American Knee Society Score (KSS) [ Time Frame: From before randomization until 3, 6, 12 and 24 months after treatment start. ]
    The Knee Society Score is a questionnaire that consist of two parts, a self-report part for patients and a section for clinicians. The scoring system includes 46 items. The self-report part assesses patients' current symptoms: 1) Objective knee score completed by clinicians (100 points), 2) Patient Satisfaction Score (40 points), and 3) Patient Expectations (15 points) and 4) Functional Activity score (100 points). The clinician part consists of information regarding joint alignment, instability, motions and symptoms. The questionnaire has a postoperativ part. The instrument includes a pre-operative and post-operative segment. Higher scores indicate better knee score/satisfaction/functioning or higher expectations.

  13. The 30 second sit to stand test [ Time Frame: From before randomization until 3, 6, 12 and 24 months after treatment start. ]
    The 30-second sit to stand test will be used to assess functional lower extremity strength(65). This test is performed using a chair of standard height without arms. The participant is encouraged to complete as many full stands as possible within 30 seconds.

  14. The 6 minute walk test [ Time Frame: From before randomization until 3, 6, 12 and 24 months after treatment start. ]
    The 6 minute walk test: The patient is instructed to walk as far as possible in 6 minutes.

  15. The ActivePal Professional single-axis accelerometer [ Time Frame: From before randomization until 3, 6, 12 and 24 months after treatment start. ]
    The ActivePal Professional single-axis accelerometer, a body worn sensor system to measure physical activity, will be used to measure time in sedentary and active positions, duration of activity and number of steps during walking

  16. Self-reported level of physical activity [ Time Frame: From before randomization until 3, 6, 12 and 24 months after treatment start. ]
    Self-reported level of physical activity will be measured using two items from the Norwegian Hunt2 survey that assess frequency of light and hard physical activity, and the Stages of Change for physical activity. The Stages of Change for physical activity assess patients' readiness for physical activity. Patients rate their agreement with five different statements about physical activity.

  17. Radiographs: weightbearing AP, lateral view, Rosenberg view and long leg weightbearing AP view (HKA) [ Time Frame: Before randomization, at 12 and 24 months following treatment start. ]
    X-rays including weightbearing AP, lateral view, Rosenberg view and long leg weightbearing AP view (HKA) weightbearing AP view (HKA). OA grading will be performed according to Kellgren-Lawrence.


Other Outcome Measures:
  1. Adverse events [ Time Frame: From randomization until 24 months following treatment start. ]

    All events reported by participant, physiotherapist or documented in the patient's hospital record.

    Hospital records:

    • During surgery: Number of patients with fractures (Tibial, patella, femur), rupture of patella tendon, other.
    • Postoperatively: Number of patients with deep infection, surgery demanding skin necrosis or scar tissue adherences, trombophlebitis demanding anticoagulant treatment, patella sub/luxation, supracondylar femur fracture, permanent n. peroneus paresis, pulmonary embolism, patella fracture, aseptic loosening, polyethylene defect (tibia or patella), secondary insertion of patella component, instability, pain without loosening, other event related to index knee, other events not related to index knee.
    • All events reported by physiotherapist - open probe questionnairing
    • All events reported by patients - open probe questionnairing

  2. Registry-based data on use of health care resources [ Time Frame: From before randomization until 3, 6, 12 and 24 months after treatment start. ]
    Use of health care resources will be measured using registry data from the KUHR-system (i.e., control and payment of reimbursements to health service providers), the Norwegian Patient Registry (NPR) and FD Trygd social security database. All information will be anonymized and linked to each patient using a code number before analysis.

  3. Adherence to the intervention (pilot study with 15 patients) [ Time Frame: From treatment start until 12 weeks following treatment start. ]
    Number of patients receiving the full dose of the intervention. adverse events, recruitment, screening and randomization, retention in study/loss to follow-up.

  4. Acceptability of the intervention (pilot study with 15 patients) [ Time Frame: From treatment start until 12 weeks following treatment start. ]
    Number of patients feeling overwhelmed or burdened by the intervention. Number of patients not completing the intervention due to feeling overwhelmed ro burdened by the intervention.

  5. Recruitment of patients (pilot study with 15 patients). [ Time Frame: Baseline(T1) ]
    Number of patients considered for inclusion

  6. Screening of patients (pilot study with 15 patients). [ Time Frame: Baseline(T1) ]
    Number of patients undergoing screening

  7. Inclusion of patients (pilot study with 15 patients). [ Time Frame: Baseline(T1) ]
    Number of patient eligible for inclusion

  8. Randomization of patients (pilot study with 15 patients). [ Time Frame: Baseline (T1) ]
    Number of patients who consent to participate and undergo randomization



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Scheduled for TKA for OA at Lovisenberg, Oslo or Kysthospitalet Hagevik, Bergen
  2. Charnley comorbidity classification A, B or C
  3. ASA grade 1-3
  4. BMI<40
  5. Able to read and write in Norwegian
  6. High risk for an unsuccessful outcome after TKA based on cutoff scores for two or more of the following screening criteria:

    • Age <55 years
    • Radiological grade of OA: Kellgren and Lawrence grade 3.
    • Preoperative pain and function level: The Knee Injury and OA Outcome Score (KOOS) pain and physical scales combined, cutoff ≤22
    • Presence of multiple painful sites/widespread pain (number of painful sites, cutoff = >2)
    • Tendency for pain-related catastrophizing (Pain Catastrophizing Scale (PCS), cutoff ≥30)
    • Pain-related fear of movement (Fear-Avoidance Belief Questionnaire (FABQ), cutoff >14.9)
    • Anxiety/depression (Hospital Anxiety and Depression (HADS) subscale scores ≥11-21)

Exclusion Criteria:

  • Diagnosis of dementia or rheumatic disease
  • Prior or current participation in a CBT or AktivA program.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771430


Contacts
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Contact: Maren Falch Lindberg, PhD +4794815762 mfli@lds.no
Contact: Anners Lerdal, PhD +4795033144 anners.lerdal@medisin.uio.no

Locations
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Norway
Haukeland University Hospital - Kysthospitalet Hagevik Not yet recruiting
Bergen, Norway
Contact: Turid Rognsvåg, Msc    +4756565964    turid.rognsvag@helse-bergen.no   
Contact: Mona Badawy, PhD    +4756565927    mona.badawy@helse-bergen.no   
Lovisenberg Diaconal Hospital Recruiting
Oslo, Norway
Contact: Maren F Lindberg, PhD    +4794815762    m.k.f.lindberg@medisin.uio.no   
Contact: Anners Lerdal, PhD    22358206    anners.lerdal@medisin.uio.no   
Sponsors and Collaborators
Lovisenberg Diakonale Hospital
Haukeland University Hospital
Investigators
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Principal Investigator: Anners Lerdal, PhD Lovisenberg Diaconal Hospital, University of Oslo
Principal Investigator: Arild Aamodt, PhD Lovisenberg Diakonale Hospital
Study Director: Maren F Lindberg, PhD Lovisenberg Diakonale Hospital/University of Oslo
Study Chair: Mona Badawy, PhD Haukeland University Hospital - Kysthospitalet Hagevik
Study Chair: Søren T Skou, PhD University of Southern Denmark
Study Chair: Milada C Småstuen, PhD University of Oslo, Oslo Metropolitan University
Study Chair: Bjørn Lau, PhD University of Oslo/Lovisenberg Diakonale Hospital
Study Chair: Caryl L Gay, PhD University of California San Francisco/Lovisenberg Diakonale Hospital
Study Chair: Petter C Borchgrevink, PhD St. Olavs Hospital, Trondheim
Study Chair: Tone Rustøen, PhD University of Oslo, Oslo University Hospital
Study Chair: Inger Holm, PhD University of Oslo
Study Chair: Ove Furnes, PhD Haukeland University Hospital, University of Bergen
Study Chair: Turid Rognsvåg, Msc Haukeland University Hospital - Kysthospitalet Hagevik/University of Bergen
Study Chair: Kari Indrekvam, PhD Haukeland University Hospital - Kysthospitalet Hagevik/University of Bergen
  Study Documents (Full-Text)

Documents provided by Lovisenberg Diakonale Hospital:
Study Protocol  [PDF] November 9, 2018


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Responsible Party: Lovisenberg Diakonale Hospital
ClinicalTrials.gov Identifier: NCT03771430     History of Changes
Other Study ID Numbers: MultiKnee Trial
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lovisenberg Diakonale Hospital:
Total knee arthroplasty
Physiotherapy
Cognitive behavioral therapy
e-therapy

Additional relevant MeSH terms:
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Joint Diseases
Osteoarthritis
Osteoarthritis, Knee
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases