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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000337

Enrollment

120

Registered

2010-03-02

Start date

2009-11-02

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F45.41

Interventions

Group 1: 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

Eligibility

Sex/Gender

All

Age

9 Years to 18 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 t	—

Measure

Time frame

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 t

—

Countries

Germany

Contacts

Public ContactAnn-Kristin Ruhe

Deutsches Kinderschmerzzentrum Vestische Kinder- und Jugendklinik Datteln Universität Witten/Herdecke

A.Ruhe@deutsches-kinderschmerzzentrum.de02363/975-183

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026