Condition category
Signs and Symptoms
Date applied
17/02/2010
Date assigned
28/05/2010
Last edited
27/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Boris Zernikow

ORCID ID

Contact details

Children's Hospital Datteln
Witten/Herdecke University
Dr.-Friedrich-Steiner-Str. 5
Datteln
45711
Germany
B.Zernikow@kinderklinik-datteln.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness and cost-analysis of a three-week multimodal inpatient pain treatment for children and adolescents suffering from chronic pain: a single centre randomised controlled trial

Acronym

WiKo-study

Study hypothesis

The present study is a cost-effectiveness study. The first aim is to investigate the short- and long-term effectiveness of a three-week multimodal inpatient pain program for children and adolescents with chronic pain. The second aim of the study is to analyse the costs determined by chronic pain before and after the inpatient pain program.

As of 01/02/2012, the anticipated end date of trial has been updated from 30/11/2011 to 24/02/2012.

Ethics approval

Ethics Committee of Witten/Herdecke University approved on the 30th September 2009

Study design

Single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (German only)

Condition

Chronic pain disorder

Intervention

All participants receive multimodal inpatient pain treatment (e.g. cognitive behavioural therapy, physiotherapy, music therapy).

Participants will be randomly allocated to one of two groups differing in time intervals between first contact and hospitalisation (admission within 1 - 5 days versus admission within 3 - 4 weeks).

The total duration of the treatments are three weeks. The total duration of follow-ups for all arms are 12 months. The timepoints are as follows:
1. First contact (randomisation)
2. 3 - 4 weeks after randomisation
3. 6 - 7 weeks after randomisation
4. 6 months after randomisation
5. 12 months after randomisation

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Composite endpoint:
1. Mean pain intensity in the last 7 days/4 weeks (adolescents on a Numerical Rating Scale [NRS], with 0 = no pain to 10 = maximal pain; children on a faces pain scale, with 0 = no pain to 10 = maximal pain)
2. Pain related disability (Pediatric Pain Disability Index [P-PDI]): disability in daily activities due to pain on 12 items, rated on a 5-point scale (1 = never to 5 = always)]
3. School absence due to pain: school absence was assessed via parental report as the number of days the child missed school within the preceding 4 weeks

Secondary outcome measures

1. Pain related coping (PPCI-R: self report questionnaire)
2. Childs and parents pain related anxiety (FSBK-K, PCS-P: self report questionnaires)
3. Parents pain related behaviour (ISEV: self report questionnaire)
4. Number of physican appointments (parental report)
5. Pain medication (physicans report by pain medical history)

Outcomes are measured at timepoints 1- 5, mentioned in the interventions section.

Overall trial start date

02/11/2009

Overall trial end date

24/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Chronic pain patients fulfilling criteria for multimodal inpatient pain treatment
2. Age at enrolment between 9 and 18 years, either sex
3. Appropriate comprehension of German

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

120

Participant exclusion criteria

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

Recruitment start date

02/11/2009

Recruitment end date

24/02/2012

Locations

Countries of recruitment

Germany

Trial participating centre

Children's Hospital Datteln
Datteln
45711
Germany

Sponsor information

Organisation

Vodafone Foundation Institute (Germany)

Sponsor details

c/o Prof Dr med Boris Zernikow
Chair for Children's Pain Therapy and Paediatric Palliative Care
Children's Hospital Datteln Witten/Herdecke University
Dr.-Friedrich-Steiner-Str. 5
Datteln
45711
Germany
B.Zernikow@kinderklinik-datteln.de

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Robert Bosch Stiftung GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24337424
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24060708

Publication citations

  1. Results

    Ruhe A, Wager J, Schmidt P, Zernikow B, [Economic effects of chronic pain in childhood and adolescence: self-assessment of health care costs for affected families before and after a multidisciplinary inpatient pain therapy]., Schmerz, 2013, 27, 6, 577-587, doi: 10.1007/s00482-013-1374-2.

  2. Results

    Hechler T, Ruhe AK, 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, 1, 118-128, doi: 10.1016/j.pain.2013.09.015.

Additional files

Editorial Notes