Trial document





This trial has been registered retrospectively.
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  DRKS00017499

Trial Description

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Title

Long-term outcome of intrathecal opiod therapy for non-malignant pain syndrome

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Background:

An estimated 12-15 Million Germans suffer from a chronic pain syndrome. In 2012, the chronic pain syndrome generated costs of 20-25 billion Euros in treatment and non-productivity in Germany. Moreover, the quality of life is severely affected by this disease. To ease pain, alternative methods have been established for pain drug delivery. This includes administration of drugs into the cerebrospinal fluid via intrathecal drug pump devices, which is performed for more than 20 years. However, to date only very few studies have been addressing the long-term efficacy of this therapeutic option scientifically.

The first pain pump devices have been implanted at the Paracelsus Hospital Osnabrück in 1985. Since then, pump patients are monitored in the Outpatient Service at the Neurosurgical Unit as well as at the Anesthesiologic Department of the Hospital. Patients are asked to present every 3 to 6 weeks cycle for pump refill services and clinical assessment. The continuous medical care of these patients provides detailed information over an extraordinary long period of time.

Main purpose:

The aim of this study is to analyze long-term results of intrathecal pain pump therapy and its related complications, risks, and side-effects. The collection of patient data is carried out by screening the medical reports and analyzing a standardized pain questionnaire, which is completed by patients. This information is used by specialists advising chronic pain patients and compared to new therapeutic methods.

Study participants:

This retrospective study includes patients with non-malignant chronic pain syndrome, which received an intrathecal pain pump at least 10 years ago in the Paracelsus Hospital Osnabrück, Germany.

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Brief Summary in Scientific Language

Background:

An estimated 12-15 Million Germans suffer from a chronic pain syndrome. In 2012, the chronic pain syndrome generated costs of 20-25 billion Euros in treatment and non-productivity in Germany. Moreover, the quality of life is severely affected by this disease. To ease pain, alternative methods have been established for pain drug delivery. This includes administion of drugs into the cerebrospinal fluid via intrathecal drug pump devices. The safety and efficacy of this therapy is mainly based on short- to intermediate term trials with a follow-up of 1 to 5 years. Nowadays, only two long-term studies are available, however, information on e.g. re-admission to the hospital, pump device revision rates or the related increase in treatment costs are not provided at all. The years and decades-long pain history makes it difficult to conduct prospective randomized controlled trials, because holding back a potentially pain reducing therapy is not well tolerated by the patients. Thus, critical evaluation of this invasive treatment method is based on long-term results of very few longitudinal studies.

Aims:

The aim of this study is to analyze long-term results of intrathecal pain pump therapy in patients with non-malignant chronic pain syndrome. Based on these data, the actual benefit and associated complications, risk, and side-effects of this method will be critically evaluated and compared to new therapeutic options, such as spinal cord stimulation or radio frequency ablation of medullary nerve fibers. To evaluate a potential cost-saving effect is another aspect of this study.

Study participants:

This retrospective study includes patients with non-malignant chronic pain syndrome, which received an intrathecal pain pump at least 10 years ago in the Paracelsus Hospital Osnabrück, Germany.

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Organizational Data

  •   DRKS00017499
  •   2019/07/02
  •   [---]*
  •   yes
  •   Approved
  •   Bo/48/2018, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

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Health Condition or Problem studied

  •   F45.41 -  [generalization F45.4: Persistent somatoform pain disorder]
  •   R52.1 -  Chronic intractable pain
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Interventions/Observational Groups

  •   Patients with chronic pain syndrome and intrathecal pump device
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Primary Endpoints: pain intensity score (visual analogue score, numeric rating scale), quality of life according to the German Pain Questionnaire

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Secondary Outcome

Secondary Endpoints: long-term complications, risk, and side-effects of intrathecal pain therapy; revision surgery, drug related effects, infections, pump associated defects/malfunction, treatment costs, drug dose

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/01/25
  •   27
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

1. Minimum age 18 years
2. drug-resistant chronic pain syndrome with a minimum duration of 1 year
3. non-malignant, not tumor-associated pain
4. All participants of this study have to be fully competent
5. Length of follow-up: minimum of 10 years after first implantation of pain pump

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Exclusion Criteria

1. Subjects under arrest or in a lawsuit
2. Incompleteness of data
3. Inaccurate documentation of patient related data
4. Pregnancy

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Addresses

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    • Abteilung für Neurochirurgie
    • Am Natruper Holz 69
    • 49076  Osnabrück
    • Germany
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    • Neurochirurgische KlinikUniversitätsmedizin Göttingen
    • Mr.  Priv.-Doz. Dr. med.  Björn  Sommer 
    • Robert-Koch-Straße 40
    • 37075  Göttingen
    • Germany
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    • Paracelsus-Klinik Osnabrück, Neurochirurgische Abteilung
    • Mr.  Mustafa  Alsharif 
    • Am Natruper Holz 69
    • 49076  Osnabrück
    • Germany
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Sources of Monetary or Material Support

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    • Neurochirurgische KlinikUniversitätsmedizin Göttingen
    • Mr.  Priv.-Doz. Dr. med.  Björn  Sommer 
    • Robert-Koch-Straße 40
    • 37075  Göttingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/06/14
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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.