fibromyalgia rheumatoid arthritis chronic back pain osthoarthrosis F45.41
Conditions
Interventions
Group 1: EMDR treatment of chronic pain patients with a total of 18 sessions using a fixed block design with alternating therapy and break blocks.
The 18 sessions extend over a total of three 4-week
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Chronic musculoskeletal pain (>3 months) as a symptom of. 1) Non-specific chronic low back pain, 2) osteoarthritis, 3) fibromyalgia syndrome, or 4) rheumatoid arthritis Sufficient legal capacity to sign an informed consent form.
Exclusion criteria
Exclusion criteria: Inadequate or unclear treatment of underlying disease (in the physician's judgment), severe pharmaceutically treated acute life-threatening physical comorbidity, or physical comorbidity that is incompatible with study participation in the physician's judgment, severe psychiatric comorbidity (inability to consent, suicidality, psychospectrum disorders), neurological comorbidity (epilepsy, traumatic brain injury, seizures, multiple sclerosis, neurodegenerative diseases), and pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall aim of the study is to identify individual treatment trajectories in EMDR therapy for chronic pain patients and to identify predictors for successful EMDR treatments. For this purpose, the change of different main outcome domains will be recorded at a total of 9 measurement time points over the course of treatment (t0/t1 = baseline measurements, t2 to t5 = interim evaluations, t6 = post-treatment, t7/t8 = follow-up measurements after 4 and 12 weeks). The following main outcome domains were defined: pain intensity and physical functioning, emotional functioning and stress experience, participant and therapist ratings of improvement, and satisfaction with treatment. These outcomes are assessed with the following questionnaires: 1. pain severity (Multidimensional Pain Inventory, MPI) during the last days. 2. disability/quality of life (Short Form-12, SF-12) during the last four weeks, or at the moment (Oswestry Disability Index, ODI). 3. anxiety and depression (Hospital Anxiety and Depression Scale, HADS) in the last few weeks. 4. patient's global impression of change (PGIC) and therapist's global impression of change (TGIC). 5. days absent from work (socioeconomic aspect) and change in medication since start of treatment. For endpoints 1-5, the change between t0/t1 and all other measurement time points will be used as an outcome variable to determine dose-response relationships. | — |
Secondary
| Measure | Time frame |
|---|---|
| Another objective of the study relates to the identification of adverse effects associated with EMDR therapy for chronic pain. The following questionnaires will be used to record these effects: 1. negative treatment effects (Negative Effects Questionnaire (NEQ) supplemented by subscales of the Inventory for the Assessment of Negative Effects of Psychotherapy (INEP) for negative effects on workplace, partnership and family/friends). Collected once post-treatment (t6). 2. severe adverse events (SAEs) such as suicidal or pain crises will be documented and reported descriptively. Will be recorded during each session conducted. In addition, the development of the therapeutic relationship from both the therapists' and the patients' perspective will be recorded at 3 measurement time points (t2, t4, t6) over the course of treatment using the Agnew Relationships Measure (ARM). | — |
Countries
Germany
Outcome results
None listed