Physiotherapy and Therapeutic Education After Total Knee Arthroplasty.

NCT ID: NCT03198247

Last Updated: 2019-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-23

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

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: 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

Group Type EXPERIMENTAL

Usual care

Intervention Type OTHER

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.

PNE + CST

Intervention Type OTHER

The PNE and CST program will be divided in 3 individual sessions.

Interventions

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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.

Intervention Type OTHER

PNE + CST

The PNE and CST program will be divided in 3 individual sessions.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role collaborator

Centro Universitario La Salle

OTHER

Sponsor Role lead

Responsible Party

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Hector Beltran-Alacreu

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Clínic de Barcelona

Barcelona, España, Spain

Site Status

Countries

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Spain

References

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Ochandorena-Acha M, Escriba-Salvans A, Hernandez-Hermoso JA, Terradas-Monllor M. Perioperative experiences of patients with high pain catastrophizing and knee arthroplasty after receiving or not preoperative physiotherapy: Qualitative study. Musculoskelet Sci Pract. 2024 Apr;70:102918. doi: 10.1016/j.msksp.2024.102918. Epub 2024 Feb 2.

Reference Type DERIVED
PMID: 38330866 (View on PubMed)

Other Identifiers

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TKA-01

Identifier Type: -

Identifier Source: org_study_id

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