Effect of a Patient Education in Pain Coping for Patients Scheduled for Total Knee Arthroplasty

NCT ID: NCT02587429

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2021-01-31

Brief Summary

The aim of this study is to investigate, whether a patient education with focus on pain coping is able to improve physical function and experienced pain level in patients with high levels of pain catastrophizing before Total Knee Arthroplasty. Resent studies indicates that these patients do not achieve a satisfactory pain relief and physical function after TKA. Furthermore, the aim is to determine if there is a difference in physical activity and muscle mass among patients with high levels of pain catastrophizing compared to patients with low levels of pain catastrophizing.

Detailed Description

In Denmark, are approximately 8000 patients operated annually with Knee Arthroplasty. Most of these patients will have less pain and higher functional ability after the surgery. However, some patients respond poorly to the surgery and approximately 20% of the patients report persistent function-limiting pain six months or more following a total knee arthroplasty (TKA).

Research has shown that patients with high pain catastrophizing scores are at higher risk of having persistent pain and lower physical function after the operation.

This study consists of two parts. The first part is a randomised controlled trial where 56 patients with high levels of pain catastrophizing before TKA are randomised to either treatment as usual (control group 1), which implies surgery and the standard postoperative rehabilitation, or in addition to this, a patient education focusing on pain behaviour and pain coping (patient education). In the second part the patients in control group 1 will be matched on age, BMI and gender with additionally 28 patients with a low levels of pain catastrophizing (control group 2).

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Patienteducation

(Patients with PCS\>22). An education in pain coping delivered by physiotherapists. The education consist of seven sessions over a four months period. Each session is individual and will last 30 minutes. Focus will be on pain behaviour and pain coping based on Cognitive Behavioral Therapy.

Group Type: EXPERIMENTAL

Patient education

Intervention Type: BEHAVIORAL

Control group 1

(Patients with PCS\>22). Patients randomly assigned to this arm will undergo usual treatment for total knee arthroplasty.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Control group 2

(Patients with PCS\<12). Patients in this arm will undergo usual treatment for total knee arthroplasty. Patients in this arm are not randomized but matched by age, gender and BMI with patients in control group 1.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patient education

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age above 18 years
• Inability to understand and communicate with the investigators
• Scheduled for an elective unilateral total knee arthroplasty
• Primary diagnosis of osteoarthritis
• Score greater than 22 or lower than 12 on the Pain Catastrophizing Scale (PCS)

Exclusion Criteria

• Planned to undergo another elective joint replacement procedure during the 12 months period of participation
• Scheduled for revision arthroplasty surgery
• TKA surgery scheduled because of fracture, malignancy or infection
• Scheduled for Unicompartmental knee arthroplasty
• Major depression diagnosed with the Major Depression Index (MDI)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regional Hospital West Jutland

OTHER

Sponsor Role: lead

Responsible Party

Sara Birch

Physiotherapist, PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Torben B Hansen, professor,MD

Role: STUDY_DIRECTOR

University Clinic for Hand, Hip and Knee Surgery, HolstebroRegional Hospital, Aarhus University, Denmark

Locations

Regional Hospital Holstebro

Holstebro, , Denmark

Countries

Denmark

References

Birch S, Stilling M, Mechlenburg I, Hansen TB. Effectiveness of a physiotherapist delivered cognitive-behavioral patient education for patients who undergoes operation for total knee arthroplasty: a protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2017 Mar 21;18(1):116. doi: 10.1186/s12891-017-1476-6.

Reference Type: DERIVED

PMID: 28320421 (View on PubMed)

Other Identifiers

VEK 1-10-72-64-15

Identifier Type: -

Identifier Source: org_study_id