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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24337424
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24060708
Publication citations
-
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.
-
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.