Trial document





This trial has been registered retrospectively.
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  DRKS00000337

Trial Description

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Title

Effectiveness and cost-analysis of a three-week multimodal inpatient pain treatment for children and adolescents suffering from chronic pain

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Trial Acronym

WiKo-Studie

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URL of the Trial

http://www.vodafone-stiftungsinstitut.de

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Brief Summary in Lay Language

Aim of the wiko-study is to investigate the effectiveness of the multimodal inpatient pain treatment for children and adolescents suffering from chronic pain in line with a randomized controlled trial. Therefore patients will be randomly allocated to one of two groups differing in time intervall between first contact and hospitalization. In addition to investigate the longterm effectiveness of the treatment an epidemiological follow-up examination above 12 months will be arranged. The third aim of the study is a cost-analysis

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Brief Summary in Scientific Language

The overall study aims to examine the model of supply of the world's first inpatient multimodal treatment program for children and adolescents with chronic pain from the perspectives of the clinical effectiveness and economic efficiency and thereby enabling a transfer into the regular supply structures for the compulsory health insurance.
These three projects will be carried out and the results will be combined as a final evaluation:
Project 1) Effectiveness of the inpatient multimodal pain therapy:
1a) Randomized controlled trial with waiting-control group design
1b) Epidemiological follow-up study over a period of 12 months
Project
2) cost analysis of inpatient multimodal pain therapy for the collection of direct and indirect costs

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Organizational Data

  •   DRKS00000337
  •   2010/03/02
  •   [---]*
  •   yes
  •   Approved
  •   78/2007, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  •   U1111-1113-7655 
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Health Condition or Problem studied

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

  •   Fast Track: Admission within 1-5 days.
    Three-week multimodal inpatient pain treatment (e.g. cognitive behavioral therapy, physiotherapy, music therapy). Optional therapies are also medication with analgesics and/ or the treatment of comorbid disorders.
  •   Best Practice: Admission within 3-4 weeks.
    Three-week multimodal inpatient pain treatment (e.g. cognitive behavioral therapy, physiotherapy, music therapy). Optional therapies are also medication with analgesics and/ or the treatment of comorbid disorders.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

To assess the therapeutic effectiveness of the therapy based on a composite endpoint overall amelioration is evaluated. This endpoint is composed of 3 parameters: pain intensity, pain-related disability and pain-related school absence. For these parameters by the method of Jacobson and Truax five outcome groups are determined depending on the occurring change (reliable change) and the value of the follow-up time:
1. Reliable deterioration
2. No change with prevalue outside normal range
(problematic)
3. No change with prevalue in normal range
(unproblematic)
4. Positive change but not clinically
significant
5. Clinically significant change

The composite endpoint consists of the following parameters:
a) Mean pain intensity in the last 7 days/ 4 weeks: This parameter is assessed for children between 9, 0 and 10, and 11 using the Faces Pain Scale-Revised. This scale consists of 6 faces, showing from left to right more pain. A numerical rating scale of 0-10 is assigned to the faces, without the children seeing these numbers. Adolescents reported their pain intensity on a NRS (with 0=no pain to 10=maximal pain). Based on findings of the adult area we defined a reduction of -1.74 as clinically relevant change.
b) Pain-related disability: The P-PDI assesses
disability in daily activities due to pain on 12 items rated
on a 5-point scale (1=never to 5=always). The items assess how often the children and adolescents are impaired in daily activities due to pain (score range: 12-60). Owing to large SD for P-PDI in our sample, we defined a change in P-PDI as clinically relevant if the values of a given patient ranges below a 90% interval of the patient population defined as X1 (score at assessment before treatment)?(1.6 SD).
c) Pain-related school absence: School absence was assessed via parental report as the number of days the child missed school within the preceding 4 weeks or 3 months. A clinically relevant change occurs if there are less than 2 days absent from school in the last four weeks.

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/11/02
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. Chronic pain patients fulfilling criteria for multimodal inpatient pain treatment
2. Appropriate comprehension of German

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Exclusion Criteria

1. Previous treatment at the Vodafone Foundation for Children`s Pain Therapy and Peadiatric Palliative Care
2. Chronic regional pain syndrome (CRPS)
3. Malignant disease

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Addresses

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Sources of Monetary or Material Support

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    • Robert-Bosch-Stiftung
    • Heidehofstr.31/ Postfach 100628
    • 70005  Stuttgart
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/09/07
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Trial Publications, Results and other Documents

  •   Hechler T, Ruhe A, Schmidt P, Hirsch J, Wager J, Dobe M, Krummenauer F, Zernikow B. Inpatient-based intensive interdisciplinary pain treatment for highly impaired children with severe chronic pain: randomized controlled trial of efficacy and economic effects. Pain 2014;155:118-128.
  •   Ruhe, A.; Wager, J.; Schmidt, P.; Zernikow, B. Ökonomische Auswirkungen chronischer Schmerzen im Kindes- und Jugendalter. Selbsteinschätzung der Krankheitskosten für betroffene Familien vor und nach einer stationären interdisziplinären Schmerztherapie. Der Schmerz 27: 577-587.
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* This entry means the parameter is not applicable or has not been set.