- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03198247
Physiotherapy and Therapeutic Education After Total Knee Arthroplasty.
Physiotherapy and Therapeutic Education in Patients With Pain Catastrophizing After a Total Knee Arthroplasty. Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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España
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Barcelona, España, Spain, 08036
- Hospital Clinic de Barcelona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Control Group: Usual Care
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. |
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. |
EXPERIMENTAL: Experimental: Usual Care + PNE and CST
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
|
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.
The PNE and CST program will be divided in 3 individual sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life. Changes from Baseline to 6 months
Time Frame: Baseline, 3 and 6 months after surgical intervention
|
Participants will be asked to complete the Euro Quality of Life (QoL) Score (EQ-5D) (Spanish version),
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Baseline, 3 and 6 months after surgical intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disability / limitations
Time Frame: Baseline, 3 and 6 months after surgical intervention
|
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.
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Baseline, 3 and 6 months after surgical intervention
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Pain intensity
Time Frame: Baseline, 3 and 6 months after surgical intervention
|
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.
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Baseline, 3 and 6 months after surgical intervention
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Function
Time Frame: Baseline, 3 and 6 months after surgical intervention
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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.
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Baseline, 3 and 6 months after surgical intervention
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Range of Motion
Time Frame: Baseline, 3 and 6 months after surgical intervention
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Goniometric assessments of knee will be carried out to assess flexion and extension range of motion.
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Baseline, 3 and 6 months after surgical intervention
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Neuropathic Pain
Time Frame: Baseline, 3 and 6 months after surgical intervention
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Participants will be asked to complete Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) (Spanish version).
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Baseline, 3 and 6 months after surgical intervention
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Pain Catastrophizing
Time Frame: Baseline, 3 and 6 months after surgical intervention
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Participants will be asked to complete the Pain Catastrophizing Scale (PCS) (Spanish version).
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Baseline, 3 and 6 months after surgical intervention
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Kinesiophobia
Time Frame: Baseline, 3 and 6 months after surgical intervention
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Participants will be asked to complete the Tampa Scale for Kinesiophobia (TSK-11) (Spanish version).
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Baseline, 3 and 6 months after surgical intervention
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Self-efficacy
Time Frame: Baseline, 3 and 6 months after surgical intervention
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Participants will be asked to complete the Chronic Pain Self-Efficacy Scale (Spanish version).
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Baseline, 3 and 6 months after surgical intervention
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Self-coping ability
Time Frame: Baseline, 3 and 6 months after surgical intervention
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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.
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Baseline, 3 and 6 months after surgical intervention
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Depression and anxiety
Time Frame: Baseline, 3 and 6 months after surgical intervention
|
Participants will be asked to complete the Hospital Anxiety and Depression Scale (HADS) (Spanish version) will be used.
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Baseline, 3 and 6 months after surgical intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TKA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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