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

ISRCTN	ISRCTN91385238
DOI	https://doi.org/10.1186/ISRCTN91385238
Secondary identifying numbers	N/A

Submission date: 17/02/2010
Registration date: 28/05/2010
Last edited: 27/02/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Boris Zernikow
Scientific

Children's Hospital Datteln
Witten/Herdecke University
Dr.-Friedrich-Steiner-Str. 5
Datteln
45711
Germany

Email	B.Zernikow@kinderklinik-datteln.de

Study information

Study design	Single centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet (German only)
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
Study acronym	WiKo-study
Study objectives	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(s)	Ethics Committee of Witten/Herdecke University approved on the 30th September 2009
Health condition(s) or problem(s) studied	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
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 study start date	02/11/2009
Completion date	24/02/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	9 Years
Upper age limit	18 Years
Sex	Both
Target number of participants	120
Key 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
Key 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
Date of first enrolment	02/11/2009
Date of final enrolment	24/02/2012

Locations

Countries of recruitment

Germany

Study participating centre

Children's Hospital Datteln

Datteln
45711
Germany

Sponsor information

Vodafone Foundation Institute (Germany)
Research organisation

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

Email	B.Zernikow@kinderklinik-datteln.de
"ROR"	https://ror.org/044qwkx83

Funders

Funder type

Research organisation

Robert Bosch Stiftung GmbH (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2013		Yes	No
Results article	results	01/01/2014		Yes	No