Chronic Widespread Pain/ Fibromyalgia Syndrome (ICD-11: MG30.01) Chronic primary musculoskeletal pain (focus on chronic primary low back pain) (ICD-11: MG30.02) Complex Regional Pain Syndrome (ICD-11: MG30.04) Chronic secondary musculoskeletal pain associated with structural changes (ICD-11: MG30.31)
Conditions
Interventions
Group 1: Arm 1 (N = 61): Brief intensive intervention using Eye Movement Desensitization and Reprocessing (EMDR) targeting memories related to adverse life events. The intervention comprises 6 session
Sponsors
Zentralinstitut für Seelische Gesundheit
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must meet the criteria for at least one of the following diagnoses: Chronic Widespread Pain/Fibromyalgia Syndrome (ICD-11: MG 30.01), Complex Regional Pain Syndrome (CPRS, ICD-11: MG 30.04), Chronic Primary Low Back Pain (ICD-11: MG30.02), or Chronic Secondary Musculoskeletal Pain with Structural Changes (ICD-11: MG 30.31). At the time of inclusion, the chronic pain should have been present for at least three months. In addition, in order to be eligible for EMDR intervention, patients are required to have experienced at least one adverse life event with a relevant degree of current subjective distress and to exhibit a relevant level of pain catastrophising.
Exclusion criteria
Exclusion criteria: • Inflammatory conditions (e.g., rheumatic or systemic inflammatory diseases, acute pronounced inflammatory states) • Diseases of the central nervous system (e.g., CNS resections, stroke, multiple sclerosis) • Contraindications to EMDR therapy (e.g., acute psychosis or severe dissociation symptoms, pronounced personality disorders) • Medication: antipsychotics, benzodiazepines, or opioids • Ongoing psychotherapy at time of enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigation of the mechanisms through which EMDR influences chronic pain by assessing changes in clinical measures of pain severity (intensity [painDETECT], pain-related distress, interference [MPI-D]) and affective symptoms (depression, anxiety, irritability, tension [DASS-21]) from baseline to post-treatment. Mediation analysis will examine whether these changes are mediated by (1) reduction in trauma-related arousal (Arm 1) or (2) reduction in pain catastrophising (Arm 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints will be examined: 1) Pain distribution (Widespread Pain Index, WPI) 2) Perceived stress (Perceived Stress Scale, PSS) 3) Sleep quality (Pittsburgh Sleep Quality Index, PSQI) 4) Pain-anxiety interaction (Tampa Scale of Kinesiophobia, TSK-11; Fear Avoidance Beliefs Questionnaire, FABQ) 5) Somatosensory outcomes: 5a) Quantitative sensory testing: pressure pain threshold (PPT), mechanical pain sensitivity (MPS), and dynamic mechanical allodynia (DMA) 5b) Pressure cuff algometry: pain detection threshold (PDT), pain tolerance threshold (PTT), spatial summation of pain (SSP), temporal summation of pain (TSP), conditioned pain modulation (CPM) 5c) Hypersensitivity using tender point count 6) Ecological Momentary Assessments (EMA) 7) Functional and structural neuroimaging: regional activation and interregional connectivity in the paraventricular thalamus (PVT) and prefrontal-limbic circuits, as well as brain structural measures (grey matter volume and white matter tract integrity) in regions including PVT, ventral striatum, prefrontal cortex, amygdala, and anterior cingulate cortex | — |
Countries
Germany
Contacts
Public ContactHeike Tost
Zentralinstitut für Seelische Gesundheit
Outcome results
None listed