Physiotherapy and Therapeutic Education After Total Knee Arthroplasty.

NCT03198247 | Withdrawn

• 1 other identifier: TKA-01
• Study Type: interventional
• Target: N/A
• 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 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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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),

  Baseline, 3 and 6 months after surgical intervention

Secondary Outcomes (10)

• Disability / limitations

  Baseline, 3 and 6 months after surgical intervention

• Pain intensity

  Baseline, 3 and 6 months after surgical intervention

• Function

  Baseline, 3 and 6 months after surgical intervention

• Range of Motion

  Baseline, 3 and 6 months after surgical intervention

• Neuropathic Pain

  Baseline, 3 and 6 months after surgical intervention

Study Arms (2)

Control Group: Usual Care

ACTIVE COMPARATOR

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.

Other: Usual care

Experimental: Usual Care + PNE and CST

EXPERIMENTAL

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

Other: Usual care; Other: PNE + CST

Interventions

Usual care 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.

Control Group: Usual Care; Experimental: Usual Care + PNE and CST

PNE + CST OTHER

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

Experimental: Usual Care + PNE and CST

Eligibility Criteria

• Age: 60 Years - 80 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.
• Knee osteoarthritis diagnosis.
• Score more than 16 points in the PCS.
• Patients between 65-80 years.

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

• Centro Universitario La Salle: lead
• Hospital Clinic of Barcelona: collaborator
• University of Barcelona: collaborator

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, España, 08036, Spain

Location

Related Publications (1)

• 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.

  PMID: 38330866 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

galactosylceramide sulfotransferase

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 26, 2017
• Study Start: November 23, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)