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Physiotherapy and Therapeutic Education on Patients With Pain Catastrophism Scheduled for a Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03847324
Recruitment Status : Suspended (COVID-19)
First Posted : February 20, 2019
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Hector Beltran-Alacreu, PhD
Information provided by (Responsible Party):
Marc Terradas Monllor, University of Barcelona

Brief Summary:
The purpose of this study is to test whether adding a treatment using pain neuroscience education (PNE) and multimodal physiotherapy to usual care, in subjects with knee osteoarthritis and pain catastrophizing, who are scheduled for a total knee arthroplasty (TKA), is more effective than only usual care. There is a high evidence level of different systematic reviews, which support the efficacy of physiotherapy treatments combined with behavioural/educational techniques aimed to reduce pain catastrophism, pain and disability in other pathologies. The primary aim of that kind of interventions is to help the subjects to reconceptualise its own pain understanding and its role on the recovery process, as well as promoting an increase of activity and encourage the subject to resume its usual activity instead of continuing to avoid it.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Knee Arthroplasty Catastrophizing Pain Other: Pain Neuroscience Education Other: Multimodal Physiotherapy Other: Usual Care Not Applicable

Detailed Description:

The prevalence of TKA has increased dramatically during the last two decades, its popularity can be attributed to its evident success regarding pain improvement, deformity correction and disability reduction in knee osteoarthritis subjects. However, only a third of the patients report no functional problems after surgery, the 20% of then are unsatisfied with its functional skills and around a 20% are experiencing pain, high disability degrees and a significant quality of life reduction. This results cannot be fully explained by mechanical processes, surgical procedures or surgery variations, but it seems to be related to other psychological aspects. Chronic pain subjects often develop maladaptive thoughts and behaviours (i.e. pain catastrophism, Kinesiophobia, activity avoidance) which contribute to make the subject suffer physically as well as emotionally, and affect on the intensity and persistency of pain.

Although many psychosocial factors have been studied, pain catastrophism has emerged as one of the most important predictors for persistent pain after a total knee arthroplasty, as well as its severity and duration, that's why it is getting more importance when it comes to study chronic pain in this subjects. Reducing pain catastrophism has become a key factor to determine the success in the rehabilitation of some maladies accompanied by pain, considering that its reduction has been associated with the clinical improvement of pain itself. It has been observed that treatments using psychological and psychosocial interventions, therapeutic education and coping skills training, or physical therapy and therapeutic exercise, are effective techniques to reduce pain catastrophism. Nevertheless, it's still necessary to determine whether the maladaptive pain related thoughts approach, using physical therapy and behavioural techniques, are able to reduce the risk of suffering postoperative chronic pain.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three armed, parallel groups, single blind, unicentric randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: Single blind
Primary Purpose: Prevention
Official Title: Physiotherapy and Therapeutic Education on Patients With Pain Catastrophism Scheduled for a Total Knee Arthroplasty: Randomized Clinical Trial
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Usual Care
Group-based preoperative biomedical education, postoperative hospital and home rehabilitation.
Other: Usual Care
Usual care will be divided in: preoperative biomedical group-based education, postoperative hospital rehabilitation and home-based postoperative physiotherapy.

Experimental: PNE
Usual care + Preoperative Pain Neuroscience Education
Other: Pain Neuroscience Education
This program is mainly based in "Explain Pain" concept, used in multiple rehabilitation programs. Its aim is to change the subject's pain understanding, teaching them the biological processes underneath the pain construct, as a mechanism to reduce itself and its related maladaptive thoughts and behaviors.
Other Name: Pain Education

Other: Usual Care
Usual care will be divided in: preoperative biomedical group-based education, postoperative hospital rehabilitation and home-based postoperative physiotherapy.

Experimental: Multimodal Physiotherapy
Usual care + Preoperative Multimodal physiotherapy
Other: Multimodal Physiotherapy
This intervention will be divided in pain neuroscience education, orthopedic manual therapy and therapeutic exercise.

Other: Usual Care
Usual care will be divided in: preoperative biomedical group-based education, postoperative hospital rehabilitation and home-based postoperative physiotherapy.




Primary Outcome Measures :
  1. Pain. Changes from baseline 6 months post-surgery. [ Time Frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery. ]
    Participants will be asked to rate their pain intensity on a horizontal 100-mm Visual Analogue Scale (VAS), ranging from 0 = no pain to 100 = worst imaginable pain. The VAS is a valid and reliable instrument compared with other pain rating scales, and has been well established in clinical practice and research for measuring pain levels in arthritis populations.


Secondary Outcome Measures :
  1. Range of Motion [ Time Frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery. ]
    Goniometric assessments of knee will be carried out to assess flexion and extension range of motion.

  2. Walking Speed [ Time Frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery. ]
    4 Meters Walking Test (4MWT) will be used to evaluate patient's walking speed.

  3. Function [ Time Frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery. ]
    30-Second Chair Stand Test (30sCST) will be use to evaluate patient's functionality on standing, because it is a well-recognized test to detect early declines in functional independence.

  4. Dynamic Balance [ Time Frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery. ]
    Y Balance Test (YBT) will be use to evaluate patient's dynamic balance.

  5. Disability / Limitation [ Time Frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery. ]
    Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (Spanish version) will be used to assess patient´s physical function. This questionnaire can be completed in less than 5 minutes. It's a widely used, reliable, valid and responsive measure of outcome in people with osteoarthritis of the hip or knee.

  6. Health-related Quality of Life [ Time Frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery. ]
    The spanish version of the Euro Quality of Life 5D-5L (EQ-5D-5L) was used to assess the health related quality of life (HRQL).(10) The EQ-5D-5L consists in two pages: the first one is based on a descriptive system that defines health in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories: no problems, slight problems, moderate problems, severe problems, extreme problems.(10) A health state is composed by taking one level for each dimension, and a preference-based scoring function is used to convert the descriptive system to a summary index score (ranging from states worse than dead <0 to full health 1).

  7. Pain Catastrophism [ Time Frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery. ]
    The Spanish version of Pain Catastrophizing Scale (PCS) was used to asses thoughts and feelings related to pain experiences.(9) The PCS is a 13 item self-administered questionnaire composed of 3 subscales: rumination, magnification and helplessness. The PCS uses a 5-point Likert scale with responses ranging from 0 = not at all to 4 = all the time. Overall scores range from 0 to 52 points, the higher the score, the higher is the pain catastrophism level.

  8. Depression and anxiety [ Time Frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery. ]
    Participants will be asked to complete the Hospital Anxiety and Depression Scale (HADS) (Spanish version) will be used. The HADS is a 14 item self-administered questionnaire comprised of 2 subscales: depression and anxiety, both composed with 7 items. Each item use a 4-point Likert scale with responses ranging from 0 to 4. Overall scores range from 0 to 21 points for each subscales, and final score is presented using each subscale scores separately. The higher the score, the higher are the anxiety or depression levels.

  9. Kinesiophobia [ Time Frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery. ]
    Participants will be asked to complete the Tampa Scale for Kinesiophobia (TSK-11) (Spanish version). TSK-11 is a 11 item self-administered questionnaire used to assess the pain-related fear of movement. The TSK-11 uses a 4-point Likert scale with responses ranging from 1 = totally disagree, to 4 = totally agree. Overall scores range from 11 to 44 indicating a higher degree of pain-related fear of movement when the score is higher.

  10. Self-efficacy [ Time Frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery. ]
    Participants will be asked to complete the Chronic Pain Self-Efficacy Scale (Spanish version). The Chronic Pain Self-Efficacy Scale is a 19 item self-administered questionnaire used to asses pain-related self-efficacy. It uses a visual analog scale for each item, ranging from 0 = totally uncapable to 10 = totally capable. Overall score ranges from 0 to 190. The higher the score, the higher is the subjects' self-efficacy.



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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:

  • To have sufficient Spanish or Catalan reading, writing and speaking skills to comprehend all explanations and to complete the assessment tools.
  • Be able to provide the informed consent.
  • Be scheduled to undergo in a total knee arthroplasty.
  • Primary knee osteoarthritis diagnosis.
  • Score more than 20 points in the Pain Catastrophizing Scale (PCS).
  • Score more than 4 over 10 on pain Visual Analogue Scale (VAS)
  • Patients older than 18 years old.

Exclusion Criteria:

  • Patients scheduled to undergo in a total knee arthroplasty because of prostheses replacement, tumor, infection or fracture.
  • Patients scheduled to undergo in a bilateral total knee arthroplasty.
  • Patients that will need another total knee or hip replacement surgery in less than a year regarding the current intervention.
  • Patients scheduled for unicompartmental knee arthroplasty.
  • Patients with other pathologies with characteristic features of a central sensitization. (i.e. Fibromyalgia)
  • Co-existing other inflammatory or rheumatic conditions (i.e. rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus or ankylosing spondylitis)
  • Co-existing other mental condition and/or major depression.

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): NCT03847324


Locations
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Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
University of Barcelona
Hector Beltran-Alacreu, PhD
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Responsible Party: Marc Terradas Monllor, Marc Terradas-Monllor, Msc, University of Barcelona
ClinicalTrials.gov Identifier: NCT03847324    
Other Study ID Numbers: FISIOPTR-01
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
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
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases