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Physiotherapy and Therapeutic Education After Total Knee Arthroplasty.

Primary Purpose

Osteoarthritis, Knee

Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Usual care
PNE + CST
Sponsored by
Centro Universitario La Salle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. To have sufficient Spanish or Catalan reading, writing and speaking skills to comprehend all explanations and to complete the assessment tools.
  2. Be able to provide the informed consent.
  3. Be scheduled to undergo in a total knee arthroplasty.
  4. Knee osteoarthritis diagnosis.
  5. Score more than 16 points in the PCS.
  6. Patients between 65-80 years.

Exclusion Criteria:

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

Sites / Locations

  • Hospital Clínic de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group: Usual Care

Experimental: Usual Care + PNE and CST

Arm Description

Procedure: Usual care The biomedical education session will be imparted 2 weeks before surgery by the preoperative nurse and a physiotherapist. It will have a duration of 2 hours and it is designed for a group of 5 subjects. The hospital rehabilitation starts 6 hours after surgery, and it is based in early wandering stimulation, articular mobility exercises and isometric exercises.

Procedure: Usual care + PNE and CST. The PNE and CST program will be divided in 3 individual sessions. 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 maladaptative thoughts and behaviours

Outcomes

Primary Outcome Measures

Quality of life. Changes from Baseline to 6 months
Participants will be asked to complete the Euro Quality of Life (QoL) Score (EQ-5D) (Spanish version),

Secondary Outcome Measures

Disability / limitations
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.
Pain intensity
Participants will be asked to rate their pain on a horizontal 100-mm Visual Analogue Scale (VAS). The horizontal line anchors will be "no pain" and "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.
Function
30-Second Chair Stand Test will be use to evaluate patient's functionality on standing, because it is a well-recognized test to detect early declines in functional independence.
Range of Motion
Goniometric assessments of knee will be carried out to assess flexion and extension range of motion.
Neuropathic Pain
Participants will be asked to complete Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) (Spanish version).
Pain Catastrophizing
Participants will be asked to complete the Pain Catastrophizing Scale (PCS) (Spanish version).
Kinesiophobia
Participants will be asked to complete the Tampa Scale for Kinesiophobia (TSK-11) (Spanish version).
Self-efficacy
Participants will be asked to complete the Chronic Pain Self-Efficacy Scale (Spanish version).
Self-coping ability
Participants will be asked to complete the "Cuestionario de Afrontamiento ante el Dolor Crónico - Versión Reducida" (CAD-R)), a Spanish questionnaire to asses self-coping ability.
Depression and anxiety
Participants will be asked to complete the Hospital Anxiety and Depression Scale (HADS) (Spanish version) will be used.

Full Information

First Posted
June 20, 2017
Last Updated
January 22, 2019
Sponsor
Centro Universitario La Salle
Collaborators
Hospital Clinic of Barcelona, University of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT03198247
Brief Title
Physiotherapy and Therapeutic Education After Total Knee Arthroplasty.
Official Title
Physiotherapy and Therapeutic Education in Patients With Pain Catastrophizing After a Total Knee Arthroplasty. Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Withdrawn
Why Stopped
low participation
Study Start Date
November 23, 2017 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitario La Salle
Collaborators
Hospital Clinic of Barcelona, University of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test whether adding a treatment using pain neuroscience education (PNE) and coping skills training (CST) 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 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.
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 maladaptative 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 maladaptative pain related thoughts approach, using physical therapy and behavioural techniques, are able to reduce the risk of suffering postoperative chronic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group: Usual Care
Arm Type
Active Comparator
Arm Description
Procedure: Usual care The biomedical education session will be imparted 2 weeks before surgery by the preoperative nurse and a physiotherapist. It will have a duration of 2 hours and it is designed for a group of 5 subjects. The hospital rehabilitation starts 6 hours after surgery, and it is based in early wandering stimulation, articular mobility exercises and isometric exercises.
Arm Title
Experimental: Usual Care + PNE and CST
Arm Type
Experimental
Arm Description
Procedure: Usual care + PNE and CST. The PNE and CST program will be divided in 3 individual sessions. 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 maladaptative thoughts and behaviours
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
The biomedical education session will be imparted 2 weeks before surgery by the preoperative nurse and a physiotherapist. It will have a duration of 2 hours and it is designed for a group of 5 subjects. The hospital rehabilitation starts 6 hours after surgery, and it is based in early wandering stimulation, articular mobility exercises and isometric exercises.
Intervention Type
Other
Intervention Name(s)
PNE + CST
Intervention Description
The PNE and CST program will be divided in 3 individual sessions.
Primary Outcome Measure Information:
Title
Quality of life. Changes from Baseline to 6 months
Description
Participants will be asked to complete the Euro Quality of Life (QoL) Score (EQ-5D) (Spanish version),
Time Frame
Baseline, 3 and 6 months after surgical intervention
Secondary Outcome Measure Information:
Title
Disability / limitations
Description
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.
Time Frame
Baseline, 3 and 6 months after surgical intervention
Title
Pain intensity
Description
Participants will be asked to rate their pain on a horizontal 100-mm Visual Analogue Scale (VAS). The horizontal line anchors will be "no pain" and "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.
Time Frame
Baseline, 3 and 6 months after surgical intervention
Title
Function
Description
30-Second Chair Stand Test will be use to evaluate patient's functionality on standing, because it is a well-recognized test to detect early declines in functional independence.
Time Frame
Baseline, 3 and 6 months after surgical intervention
Title
Range of Motion
Description
Goniometric assessments of knee will be carried out to assess flexion and extension range of motion.
Time Frame
Baseline, 3 and 6 months after surgical intervention
Title
Neuropathic Pain
Description
Participants will be asked to complete Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) (Spanish version).
Time Frame
Baseline, 3 and 6 months after surgical intervention
Title
Pain Catastrophizing
Description
Participants will be asked to complete the Pain Catastrophizing Scale (PCS) (Spanish version).
Time Frame
Baseline, 3 and 6 months after surgical intervention
Title
Kinesiophobia
Description
Participants will be asked to complete the Tampa Scale for Kinesiophobia (TSK-11) (Spanish version).
Time Frame
Baseline, 3 and 6 months after surgical intervention
Title
Self-efficacy
Description
Participants will be asked to complete the Chronic Pain Self-Efficacy Scale (Spanish version).
Time Frame
Baseline, 3 and 6 months after surgical intervention
Title
Self-coping ability
Description
Participants will be asked to complete the "Cuestionario de Afrontamiento ante el Dolor Crónico - Versión Reducida" (CAD-R)), a Spanish questionnaire to asses self-coping ability.
Time Frame
Baseline, 3 and 6 months after surgical intervention
Title
Depression and anxiety
Description
Participants will be asked to complete the Hospital Anxiety and Depression Scale (HADS) (Spanish version) will be used.
Time Frame
Baseline, 3 and 6 months after surgical intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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. Knee osteoarthritis diagnosis. Score more than 16 points in the PCS. Patients between 65-80 years. 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.
Facility Information:
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
State/Province
España
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Physiotherapy and Therapeutic Education After Total Knee Arthroplasty.

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