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

NCT03847324 | Completed

• 1 other identifier: FISIOPTR-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee; Knee Arthroplasty; Catastrophizing; Pain

Outcome Measures

Primary Outcomes (1)

• Pain. Changes from baseline 6 months post-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.

  Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.

Secondary Outcomes (10)

• Range of Motion

  Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.

• Walking Speed

  Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.

• Function

  Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.

• Dynamic Balance

  Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.

• Disability / Limitation

  Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

PNE

EXPERIMENTAL

Usual care + Preoperative Pain Neuroscience Education

Other: Pain Neuroscience Education; Other: Usual Care

Multimodal Physiotherapy

EXPERIMENTAL

Usual care + Preoperative Multimodal physiotherapy

Other: Multimodal Physiotherapy; Other: Usual Care

Interventions

Pain Neuroscience Education 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.

Also known as: Pain Education

PNE

Multimodal Physiotherapy OTHER

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

Multimodal Physiotherapy

Usual Care OTHER

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

Multimodal Physiotherapy; PNE; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Barcelona: lead
• Hector Beltran-Alacreu, PhD: collaborator

Study Sites (1)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Related Publications (1)

• 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.

  PMID: 39797350 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marc Terradas-Monllor, Msc

Model Details: Three armed, parallel groups, single blind, unicentric randomized controlled trial

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 20, 2019
• Study Start: September 18, 2019
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)