NCT02587429

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

4.6 years

First QC Date

October 23, 2015

Last Update Submit

January 27, 2020

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Pain measured on a Visual Analog Scale (0-100)

    12 months

Secondary Outcomes (10)

  • Six-minute Walk Test

    12 months

  • Sit-to-stand in 30 seconds

    12 months

  • EuroQol (EQ-5D)

    12 months

  • Pain Catastrophizing Scale

    12 months

  • Knee injury and Osteoarthritis Outcome Score (KOOS)

    12 months

  • +5 more secondary outcomes

Study Arms (3)

Patienteducation

EXPERIMENTAL

(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.

Behavioral: Patient education

Control group 1

NO INTERVENTION

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

Control group 2

NO INTERVENTION

(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.

Interventions

Patient educationBEHAVIORAL
Patienteducation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Hospital Holstebro

Holstebro, 7500, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 28320421DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Torben B Hansen, professor,MD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, PhD Student

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 27, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2020

Study Completion

January 1, 2021

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations

DK(1)