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

Authors
Category Primary study
Registry of TrialsGerman Clinical Trials Register
Year 2010
INTERVENTION: Intervention 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 with analgesics and/ or the treatment of comorbid disorders. Intervention 2: 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. CONDITION: F45.41 ‐ [generalization F45.4: Persistent somatoform pain disorder] INCLUSION CRITERIA: 1. Chronic pain patients fulfilling criteria for multimodal inpatient pain treatment 2. Appropriate comprehension of German 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.
Epistemonikos ID: 314c8acd25e7ba999e877eee8b3be1ef2cd4be0b
First added on: Aug 22, 2024