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

NCT ID: NCT03847324

Last Updated: 2023-05-11

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-18

Study Completion Date

2023-03-14

Brief Summary

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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.

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 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.

Conditions

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Osteo Arthritis Knee Knee Arthroplasty Catastrophizing Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three armed, parallel groups, single blind, unicentric randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Single blind

Study Groups

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Usual Care

Group-based preoperative biomedical education, postoperative hospital and home rehabilitation.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

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

PNE

Usual care + Preoperative Pain Neuroscience Education

Group Type EXPERIMENTAL

Pain Neuroscience Education

Intervention Type OTHER

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.

Usual Care

Intervention Type OTHER

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

Multimodal Physiotherapy

Usual care + Preoperative Multimodal physiotherapy

Group Type EXPERIMENTAL

Multimodal Physiotherapy

Intervention Type OTHER

This intervention will be divided in pain neuroscience education, orthopedic manual therapy and therapeutic exercise.

Usual Care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Multimodal Physiotherapy

This intervention will be divided in pain neuroscience education, orthopedic manual therapy and therapeutic exercise.

Intervention Type OTHER

Usual Care

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

Intervention Type OTHER

Other Intervention Names

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Pain Education

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hector Beltran-Alacreu, PhD

UNKNOWN

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Marc Terradas Monllor

Marc Terradas-Monllor, Msc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Countries

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Spain

References

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Terradas-Monllor M, Beltran-Alacreu H, Ochandorena-Acha M, Garcia-Oltra E, Aliaga-Orduna F, Hernandez-Hermoso J. Preoperative Home-Based Multimodal Physiotherapy in Patients Scheduled for a Knee Arthroplasty Who Catastrophize About Their Pain: A Randomized Controlled Trial. J Clin Med. 2025 Jan 5;14(1):268. doi: 10.3390/jcm14010268.

Reference Type DERIVED
PMID: 39797350 (View on PubMed)

Other Identifiers

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FISIOPTR-01

Identifier Type: -

Identifier Source: org_study_id

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