Effect of pre-operative pain treatment on postoperative outcome after total hip or knee replacement surgery

Effect of pre-operative pain treatment by means of duloxetine on postoperative outcome after total hip or knee arthroplasty - Duloxetine In OsteoArthritis study (DOA-study)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004313-41-NL

Enrollment

Unknown

Registered

2014-02-24

Start date

2014-05-19

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis (knee or hip) MedDRA version: 19.0 Level: PT Classification code 10031161 Term: Osteoarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.0 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.0 Level: LLT Classification code 10020108 Term: Hips osteoarthritis System Organ Class: 10028395 - Musculoskeletal and conn

Interventions

Trade Name: Cymbalta Pharmaceutical Form: Gastro-resistant capsule, hard

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Primary Osteoarthritis (based on clinical and radiological ACR-criteria) 2. Age >18 years 3. A neuropathic or at least a mixed neuropathic / noiciceptive pain phenotype (m-painDETECT-score >12) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 49 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: General exclusion criteria: 1. Surgical hip or knee joint procedures less than 1 year previously 2. Cognitive and/or neurological disorders that could interfere strongly with questionnaire surveys (e.g. Dementia) 3. Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation. 4. Planned or intended to perform THA or TKA within the study duration (present planned arthroplasty not included) 5. A history of peripheral nerve injury 6. Previous exposure to Duloxetine Duloxetine related exclusion criteria: 7. Allergy to study medication or compounds of the Duloxetine capsule (or another SNRI); 8. History of peptic ulcer disease or bleeding disorder (or other substantial risk factor for bleeding) 9. Psychiatric disorders, other than depression; 10. Severe depression (HADS score >15 on depression subscale); 11. A history of alcohol or other substance abuse (excluding nicotine and caffeine) or dependence within the five years prior to enrollment; 12. Currently pregnant or lactating, our planned to become pregnant within the study period 13. History of cardiac arrhythmias, cardiac failure, myocardial infarct; 14. impaired function of the liver, or known cirrhosis or liver transplantation; 15. severe renal impairment, or had renal transplantation or receiving renal dialysis; 16. Hyponatraemia, or a history of frequent hyponatremias; 17. History of uncontrolled hypertension, history of glaucoma (or with increased intraocular pressure) ,uncontrolled thyroid disease and a history of uncontrolled seizures; 18. Usage of non selective monoamine oxidase (MAO) inhibitors, TCA’s , SSRIs, SNRIs in the last year; 19. Usage of strong CYP1A2-inhibitors

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the degree pain relief 6 months after THA/TKA when screened pre-operative for centralized pain and subsequent treated accordingly for a period of 10 weeks with Duloxetine compared to usual care (no Duloxetine) ;Secondary Objective: To determine the effect at different follow-up time points when screened pre-operative for centralized pain and subsequent treated accordingly for a period of ten weeks with Duloxetine compared to treated as usual (no Duloxetine) on: * The degree of pain relief and neuropathic pain symptoms; * The degree of sensitisation/sensitivity (measured by QST); * The degree of functional improvement and physical activity; * Quality of life and perceived satisfaction//expectation level (at the time on waiting list); * Depressive and anxiety symptoms. * The degree of Pain Catastrophizing ;Primary end point(s): The degree of postoperative pain, assessed with the pain subscales of the Knee injury and Osteoarthritis Outcome Score (KOOS) or the Hip disability and Osteoarthritis Outcome Score (HOOS).;Timepoint(s) of evaluation of this end point: 6 months after THA/TKA	—

Measure

Time frame

Main Objective: To determine the degree pain relief 6 months after THA/TKA when screened pre-operative for centralized pain and subsequent treated accordingly for a period of 10 weeks with Duloxetine compared to usual care (no Duloxetine) ;Secondary Objective: To determine the effect at different follow-up time points when screened pre-operative for centralized pain and subsequent treated accordingly for a period of ten weeks with Duloxetine compared to treated as usual (no Duloxetine) on: * The degree of pain relief and neuropathic pain symptoms; * The degree of sensitisation/sensitivity (measured by QST); * The degree of functional improvement and physical activity; * Quality of life and perceived satisfaction//expectation level (at the time on waiting list); * Depressive and anxiety symptoms. * The degree of Pain Catastrophizing ;Primary end point(s): The degree of postoperative pain, assessed with the pain subscales of the Knee injury and Osteoarthritis Outcome Score (KOOS) or the Hip disability and Osteoarthritis Outcome Score (HOOS).;Timepoint(s) of evaluation of this end point: 6 months after THA/TKA

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Secondary

Measure	Time frame
Secondary end point(s): Pain Secondary endpoints that will be used to asses the change of perceived pain are the Visual Analogue Scale (VAS) and the pain subscales of the KOOS/HOOS. Neuropathic pain will be assessed by means of the modified-painDETECT (m-PDQ) questionnaire (knee m-PDQ, hip m-PDQ). Sensitisation/sensitivity measurements (QST) A multimodel assessment of pain responses will be performed to assess characteristics associated with neuropathic pain and/or (central) sensitization. Two QST-measurements will be assessed, namely; Mechanical Temporal Summation (MTS) and Blunt Pressure Pain Thresholds (PPT). Function and physical activity Change of function will be assessed by means of the following KOOS/HOOS subscales: symptoms, ADL and sport/recreation. Change of physical activity will be assessed by means of the International Physical Activity Questionnaire (IPAQ) Quality of life and satisfaction Change of quality of life will be assessed by means of the QOL subscale of the KOOS/HOOS and the SF-36 questionnaire. Patients perceived level of expectation at the time on the waiting list (in relation to postoperative outcomes) will be assed by means of the Hospital for Special Surgery Knee Replacement Expectations survey (HSSKR) and with the Hospital for Special Surgery Hip Replacement Expectations survey (HSSHR). Furthermore, the Patient Global Impression of Improvement (PGI-I) scale will be obtained to measure a change in the level of satisfaction. Depression and anxiety Change in depression and anxiety will be assessed by means of the Hospital Anxiety and Depression Scale (HADS). Pain catastrophizing Pain catastrophizing will be assessed by means of the pain catastrophizing questionnaire (PCS). ;Timepoint(s) of evaluation of this end point: Pain-related time-points: T1 (2 weeks after duloxetine initiation/baseline) T2 (8 weeks after duloxetine initiation/baseline) T4 (2 days postoperative) T5 (6 weeks postoperat	—

Measure

Time frame

Secondary end point(s): Pain Secondary endpoints that will be used to asses the change of perceived pain are the Visual Analogue Scale (VAS) and the pain subscales of the KOOS/HOOS. Neuropathic pain will be assessed by means of the modified-painDETECT (m-PDQ) questionnaire (knee m-PDQ, hip m-PDQ). Sensitisation/sensitivity measurements (QST) A multimodel assessment of pain responses will be performed to assess characteristics associated with neuropathic pain and/or (central) sensitization. Two QST-measurements will be assessed, namely; Mechanical Temporal Summation (MTS) and Blunt Pressure Pain Thresholds (PPT). Function and physical activity Change of function will be assessed by means of the following KOOS/HOOS subscales: symptoms, ADL and sport/recreation. Change of physical activity will be assessed by means of the International Physical Activity Questionnaire (IPAQ) Quality of life and satisfaction Change of quality of life will be assessed by means of the QOL subscale of the KOOS/HOOS and the SF-36 questionnaire. Patients perceived level of expectation at the time on the waiting list (in relation to postoperative outcomes) will be assed by means of the Hospital for Special Surgery Knee Replacement Expectations survey (HSSKR) and with the Hospital for Special Surgery Hip Replacement Expectations survey (HSSHR). Furthermore, the Patient Global Impression of Improvement (PGI-I) scale will be obtained to measure a change in the level of satisfaction. Depression and anxiety Change in depression and anxiety will be assessed by means of the Hospital Anxiety and Depression Scale (HADS). Pain catastrophizing Pain catastrophizing will be assessed by means of the pain catastrophizing questionnaire (PCS). ;Timepoint(s) of evaluation of this end point: Pain-related time-points: *T1 (2 weeks after duloxetine initiation/baseline) *T2 (8 weeks after duloxetine initiation/baseline) *T4 (2 days postoperative) *T5 (6 weeks postoperat

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Countries

Netherlands

Contacts

Public ContactDepartment of Orthopaedics

UMCG

m.stevens@umcg.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026