Trial document




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  DRKS00005147

Trial Description

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Title

Predictors of persistent postoperative pain following total knee replacement

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Trial Acronym

PPoP-TKR

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URL of the Trial

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Brief Summary in Lay Language

There is variability in improvement of postoperative pain intensity following total knee replacement. The aim of this project is to investigate, if these individual pain profiles could be predicted using a standardized screening protocol. This could contribute to further improvement of both medical and rehabilitative treatment strategies according to the patients individual constitution. Patients will participate at two additional assessment sessions: before and six month after total knee replacement. We will use various tests in our examination procedure. We will record the heart rate variability (the normal variability from heart beat to heart beat) at rest. Furthermore we will investigate the pressure pain threshold at the thumb of the dominant hand in a sitting position. Thus, we investigate at what pressure intensity the sensation becomes just noticeably painful. Additionally five series of ten short mechanical stimulations with a special filament will be applied at the patients forearm and the patients will be asked to rate the intensity of the first and the tenth stimulus at each point. Moreover, a constant mechanical stimulation of the interdigital web between the index and middle finger of the non dominant hand will be applied using the individual determined pressure intensity for each single patient respectively. After a stimulation period of initially two minutes we will examine the pressure pain threshold at the thumb again as described above. All tests will be applied in an area that is remote from the painful knee to examine if there are signs of central sensitization - independent of the affected joint. Furthermore, patients will be asked to fill out several validated questionnaires regarding pain intensity, activity limitations etc.

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Brief Summary in Scientific Language

Introduction

Persistent postoperative pain is a common and disabling health problem following total knee replacement with an incidence up to 53% (1). Relevant predictors are female sex (OR: 1,23) (1), a high praeoperative pain intensity at rest (OR: 6,48) (2) and a high level of pain catastrophizing (OR: 2,67) (3). The examination of spinal sensitization and effectivity of endogenous pain inhibition may be useful in identifying patients at risk for the development of chronic pain (4). Furthermore, there is evidence, that the vegetative nervous system could modulate pain processing following surgery (5). Thus, dysregulations at nociceptive, vegetative and affective levels could be related to persistent postoperative pain following total knee replacement.

Research question:
Are gender, pain intensity, wind-up ratio, effectivity of conditioned pain modulation, heart rate variability and pain catastrophizing predictors of persistent postoperative pain following total knee replacement?

Methods

Patients with osteoarthritis of the knee who were scheduled for total knee replacement will be invited to participate at a praeoperative screening using questionnaires (e.g. Western Ontario and McMaster Universities Osteoarthritis Index und Pain Catastrophizing Scale) and different test procedures, including the following parameters: determining wind up ratio as a measure of spinal sensitization, examination of the effectivity of endogenous pain inhibitory pathways (conditioned pain modulation test paradigm) and measurement of heart rate variability as a measure of vegetative function.
Additionally we will document general demografic data, the patient´s expectations of knee surgery and use a questionnaire to examine depressive symptoms (German version of the Center for Epidemiological Studies Depression Scale).
The screening procedure is standardized and reliability of the examination protocol has been examined in a preliminary study with 20 healthy, pain-free subjects.

Follow up:
During the six month follow up patients will attend at all of their routine rehabilitation treatments. There are no additional interventions. Six month following total knee replacement surgery the patients will be invited and examined again as described above.

Sample size calculation:
Our sample size calculation was based on G*Power (linear multiple regression, fixed model, R2 deviation from zero). 103 patients were needed to detect a medium effect (7 predictors: gender, pain intensity, wind up ratio, effectivity of conditioned pain modulation, 2 parameters of heart rate variability and pain catastrophizing; a=0,05; cohens f2=0,15 within the cohen´s medium to large effect range from 0,15-0,35 for multiple regression) with a power of 0,8.

Statistical analysis:
The association between the preoperative screening measures as independent variables and pain intensity at six month follow up as dependent variables were examined using multiple regression analysis.

Relevance:
The new screening procedure creates new opportunities to adopt therapeutic strategies according to the risk profile of the individual patient.


Literature
1 Liu SS, Buvanendran A, Rathmell JP, Sawhney M, Bae JJ et al. 2012. A cross-sectional survey on prevalence and risk factors for persistent postsurgical pain 1 year after total hip and knee replacement. Reg Anesth Pain Med. 37; 4:415-22
2 Lundblad H, Kreicbergs A, Jansson KA. 2008. Prediction of persistent pain after total knee replacement for osteoarthritis. The Journal of bone and joint surgery. British volume 90:166-71
3 Riddle DL, Wade JB, Jiranek WA, Kong X. 2010. Preoperative pain catastrophizing predicts pain outcome after knee arthroplasty. Clinical orthopaedics and related research 468:798-806
4 Weissman-Fogel I, Granovsky Y, Crispel Y, Ben-Nun A, Best LA, et al. 2009. Enhanced presurgical pain temporal summation response predicts post-thoracotomy pain intensity during the acute postoperative phase. J Pain 10:628-36
5 Bantel C, Trapp S. 2011. The role of the autonomic nervous system in acute surgical pain processing - what do we know? Anaesthesia 66:541-4

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Organizational Data

  •   DRKS00005147
  •   2013/07/26
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  •   yes
  •   Approved
  •   5498/12, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  •   U1111-1145-6587 
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Health Condition or Problem studied

  •   M17 -  Gonarthrosis [arthrosis of knee]
  •   R52 -  Pain, not elsewhere classified
  •   Persistent postoperative pain
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Interventions/Observational Groups

  •   Patients with osteoarthritis of the knee who were scheduled for total knee replacement will be invited to participate at a praeoperative screening using the questionnaires Western Ontario and McMaster Universities Osteoarthritis Index und Pain Catastrophizing Scale. Furthermore various test procedures will be applied including the following parameters: determining wind up ratio as a measure of spinal sensitization, examination of the effectivity of endogenous pain inhibitory pathways (conditioned pain modulation test paradigm) and measurement of heart rate variability as a measure of vegetative function. The screening procedure is standardized and reliability of the examination protocol has been examined in a preliminary study with 20 healthy, pain-free subjects.
    Additionally we will document general demografic data, the patient´s expectations of knee surgery and use a questionnaire to examine depressive symptoms (German version of the Center for Epidemiological Studies Depression Scale).
    Six month following surgery the patients will be examined again.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The project aims to evaluate a new screening procedure to identify patients at risk for chronic pain following total knee replacement at a preoperative state by using a multifactorial approach of dynamic psychophysical tests combined with measuring of vegetative function and evaluation of affective and cognitive dysregulation.

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Secondary Outcome

Not applicable

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/07/02
  •   103
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Patients with osteoarthritis of the knee who were scheduled for primary total knee replacement and signed the written informed consent will be included in the study.

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Exclusion Criteria

Exclusion criteria were neurological diseases, severe internal (e.g. chron. kidney diseases or diabetic neuropathy) or psychological (e.g. schizophrenia or major depression) diseases, unicondylar knee arthroplasty and previous knee surgery in the last two years (except arthroscopy). Patients with chronic pain using opioids will be excluded as well.

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Addresses

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    • Technische Universität München Fakultät für Sport- und Gesundheitswissenschaften Fachbereich Konservative und Rehabilitative Orthopädie
    • 80992  München
    • Germany
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    • Technische Universität München Fakultät für Sport- und Gesundheitswissenschaften Fachbereich Konservative und Rehabilitative Orthopädie TUM Campus D, Raum M409
    • Ms.  MSc.  Tanja  Bossmann 
    • Georg-Brauchle-Ring 60/62
    • 80992  München
    • Germany
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    • Technische Universität München Fakultät für Sport- und Gesundheitswissenschaften Fachbereich Konservative und Rehabilitative Orthopädie TUM Campus D, Raum M409
    • Ms.  MSc.  Tanja  Bossmann 
    • Georg-Brauchle-Ring 60/62
    • 80992  München
    • Germany
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Sources of Monetary or Material Support

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    • Technische Universität München Fakultät für Sport- und Gesundheitswissenschaften Fachbereich Konservative und Rehabilitative Orthopädie
    • 80992  München
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.