The PerPAIN trial: a pilot randomized controlled trial of personalized treatment allocation for chronic musculoskeletal pain-a protocol.

BACKGROUND: The therapy of chronic musculoskeletal pain (CMSP) is complex and the treatment results are often insufficient despite numerous therapeutic options. While individual patients respond very well to specific interventions, other patients show no improvement. Personalized treatment assignment offers a promising approach to improve response rates; however, there are no validated cross-disease allocation algorithms available for the treatment of chronic pain in validated personalized pain interventions. This trial aims to test the feasibility and safety of a personalized pain psychotherapy allocation with three different treatment modules and estimate initial signals of efficacy and utility of such an approach compared to non-personalized allocation. METHODS: This is a randomized, controlled assessor-blinded pilot trial with a multifactorial parallel arm design. CMSP patients (n = 105) will be randomly assigned 1:1 to personalized or non-personalized treatment based on a cluster assignment of the West Haven-Yale Multidimensional Pain Inventory (MPI). In the personalized assignment condition, patients with high levels of distress receive an emotional distress-tailored intervention, patients with pain-related interference receive an exposure/extinction-tailored treatment intervention and patients who adapt relatively well to the pain receive a low-level smartphone-based activity diary intervention. In the control arm, patients receive one of the two non-matching interventions. Effect sizes will be calculated for change in core pain outcome domains (pain intensity, physical and emotional functioning, stress experience, participant ratings of improvement and satisfaction) after intervention and at follow-up. Feasibility and safety outcomes will assess rates of recruitment, retention, adherence and adverse events. Additional data on neurobiological and psychological characteristics of the patients are collected to improve treatment allocation in future studies. CONCLUSION: Although the call for personalized treatment approaches is widely discussed, randomized controlled trials are lacking. As the personalization of treatment approaches is challenging, both allocation and intervention need to be dynamically coordinated. This study will test the feasibility and safety of a novel study design in order to provide a methodological framework for future multicentre RCTs for personalized pain psychotherapy. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00022792 ( https://www.drks.de ). Prospectively registered on 04/06/2021.

[Influence of early childhood stress exposure and traumatic life events on pain perception]. / Einfluss frühkindlicher Stresserfahrungen und traumatisierender Lebensereignisse auf das Schmerzempfinden.

Adult pain perception is influenced substantially by interactions between mind, body, and social environment during early life. Early stress exposure and traumatic life events induce powerful psychophysical stress reactions that exert multiple neurofunctional processes. This has significant implications for pain perception and pain processing. As part of this review, the complex relationships between traumatic stress experiences and associated psychobiological mechanisms of chronic pain will be discussed. Based on selected studies, psychophysiological findings are presented and possible underlying mechanisms are discussed. The article concludes with a discussion of potential implications for treatment.

Pilot-RCT of an integrative group therapy for patients with refractory irritable bowel syndrome (ISRCTN02977330).

OBJECTIVE: Different forms of psychotherapeutic treatments have been proven effective in irritable bowel syndrome (IBS), but disorder-oriented and integrative concepts are still rare. Therefore, we implemented and evaluated an integrative group therapeutic concept within an interdisciplinary tertiary care clinic for functional gastrointestinal disorders (FGIDs). AIMS: present our integrative group concept, assess feasibility issues, and evaluate efficacy. METHODS: A pilot-RCT with a randomized controlled wait-listed group design was conducted. The treatment concept was a disorder-oriented multicomponent group therapy (12 90-min weekly sessions) integrating interactive psychoeducation, gut-directed hypnotherapy, and open group phases. All patients received enhanced medical care and completed a short online diary as an active wait-listed control condition. INCLUSION CRITERIA: refractory IBS diagnosed as somatoform autonomic dysfunction of the lower gastrointestinal tract (SAD). PRIMARY OUTCOME: IBS symptom severity (IBS-SSS). RESULTS: Of 294 patients, 220 had IBS (ROME III), 144 were diagnosed as SAD (ICD-10), 51 were eligible regarding inclusion/exclusion criteria, and 30 consented to participate (group intervention: n=16, wait-listed control condition: n=14). Only 1 patient dropped out. Intention-to-treat-analysis with repeated-measures mixed ANOVA showed that the group intervention was not significantly superior to the wait-listed control condition. Nevertheless, the calculated effect size for the between-group difference in IBS-SSS at the end of treatment (post) was moderate (d=0.539). CONCLUSION: Our disorder-oriented integrative group intervention for IBS proved to be acceptable and feasible in an interdisciplinary tertiary care setting. There is promise in this intervention, but a larger RCT may be needed to investigate efficacy.

[EMDR as a psychotherapeutic approach in the treatment of chronic pain : Is Eye Movement Desensitization and Reprocessing an effective therapy for patients with chronic pain who do not suffer from posttraumatic stress disorder?] / EMDR als psychotherapeutischer Ansatz in der Schmerztherapie : Ist "eye movement desensitization and reprocessing" eine wirksame Therapie bei Patienten mit chronischen Schmerzen ohne posttraumatische Belastungsstörung?

The efficacy of Eye Movement Desensitization and Reprocessing (EMDR) has been demonstrated for posttraumatic stress disorder. Despite promising research, it is still not clear if EMDR is a similarly effective treatment for chronic pain. Controlled trials are lacking and whether specific mechanisms underlie the effects remains unknown. The treatment of chronic pain aims at a reduction of subjective pain sensations. To achieve this goal without the usage of pain medications, i. e. through psychotherapy, is desirable for many reasons (e. g. reduction of treatment costs and side effects). Whether or not EMDR is an effective intervention for all chronic pain patients (or just a specific subgroup) constitutes an important question for psychological pain research.

[Childhood abuse experiences and chronic low back pain. Direct and mediated effects of childhood abuse in different pain dimensions of nonspecific chronic low back pain]. / Frühe Missbrauchserlebnisse bei chronischem Kreuzschmerz. Direkte und mediierte Effekte früher Missbrauchserlebnisse auf verschiedene Schmerzdimensionen chronischer nichtspezifischer Kreuzschmerzen.

BACKGROUND: Physical, sexual and emotional abuse in childhood and adolescence is considered to play a role in the etiology and generalization of chronic pain in adulthood. However, it remains unclear whether abuse is specifically associated with different dimensions of nonspecific chronic low back pain (CLBP) and if these associations are mediated by psychological symptoms. MATERIAL AND METHODS: A total of 103 patients with validated CLBP were assessed by pain drawing, the multidimensional pain questionnaire and the pain experience scale. The childhood trauma questionnaire was used to retrospectively screen for physical, sexual and emotional abuse in childhood and adolescence. Patients were also screened for symptoms of depression, anxiety and dissociation in order to look for possible mediators. RESULTS: Patients with CLBP who reported childhood abuse showed higher pain intensity, higher spatial extent of pain, higher affective and sensory pain sensation and more pain disability compared to CLBP patients who had not experienced abuse. However, multivariate analyses revealed that only the spatial extent of pain was directly associated with childhood abuse. Furthermore, a significant association between childhood abuse and sensory pain sensation was found to be mediated by symptoms of anxiety and dissociation. CONCLUSION: The influence of childhood abuse on CLBP is different for specific pain dimensions; therefore, CLBP should be faced as a complex construct that comprises different dimensions. Childhood abuse is suggested as a risk factor for spreading pain in CLBP persons; therefore, CLBP patients reporting additional pain locations might benefit from diagnostic and therapeutic interventions specific for childhood abuse experiences.

Sensory innervation of the thoracolumbar fascia in rats and humans.

The available data on the innervation of the thoracolumbar fascia (TLF) are inconsistent and partly contradictory. Therefore, the role of the fascia as a potential source of pain in the low back is difficult to assess. In the present study, a quantitative evaluation of calcitonin gene-related peptide (CGRP) and substance P (SP)-containing free nerve endings was performed in the rat TLF. A preliminary non-quantitative evaluation was also performed in specimens of the human TLF. The data show that the TLF is a densely innervated tissue with marked differences in the distribution of the nerve endings over the fascial layers. In the rat, we distinguished three layers: (1) Outer layer (transversely oriented collagen fibers adjacent to the subcutaneous tissue), (2) middle layer (massive collagen fiber bundles oriented obliquely to the animal's long axis), and (3) inner layer (loose connective tissue covering the paraspinal muscles). The subcutaneous tissue and the outer layer showed a particularly dense innervation with sensory fibers. SP-positive free nerve endings-which are assumed to be nociceptive-were exclusively found in these layers. Because of its dense sensory innervation, including presumably nociceptive fibers, the TLF may play an important role in low back pain.