Clinical trial NCT02587429: Effect of a Patient Education in Pain Coping for Patients Scheduled for Total Knee Arthroplasty
Official title: Effect of a Patient Education in Pain Coping for Patients With High Levels of Pain Catastrophizing Before Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Regional Hospital West Jutland
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Pain measured on a Visual Analog Scale (0-100)
timeFrame: 12 months
Secondary outcomes:
measure: Six-minute Walk Test
timeFrame: 12 months
measure: Sit-to-stand in 30 seconds
timeFrame: 12 months
measure: EuroQol (EQ-5D)
timeFrame: 12 months
measure: Pain Catastrophizing Scale
timeFrame: 12 months
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 12 months
measure: Short Form 36 (Physical Function)
timeFrame: 12 months
measure: Dual Energy X-ray Absorptiometry (DXA) scan
timeFrame: 12 months
measure: Tri-axial-accelerometer
timeFrame: 12 months
measure: Oxford Knee Score
timeFrame: 12 months
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: 12 months
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Regional Hospital Holstebro
Study officials:
affiliation: University Clinic for Hand, Hip and Knee Surgery, HolstebroRegional Hospital, Aarhus University, Denmark
name: Torben B Hansen, professor,MD
role: STUDY_DIRECTOR
References:
citation: 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.