Fibromyalgia Rheumatoid Arthritis Chronic back pain Osteoarthrosis M79.7
Conditions
Interventions
Group 1: Arm 1: Personalized treatment-matched allocation
n = 45
Group 2: Arm 2: Non-personalized treatment/non-matched allocation
n = 45
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The inclusion and exclusion criteria are chosen to ensure good representativeness and to cover the heterogeneity of musculoskeletal conditions. Key inclusion criteria: chronic musculoskeletal pain (CMSP) >3 months as symptom of 1.) non-specific chronic back pain, 2.) osteoarthritis, 3.) fibromyalgia syndrome, or 4.) rheumatoid arthritis; the ability to see and use a mobile telephone (incl. with visual aids), age =18 years and ability to provide informed consent.
Exclusion criteria
Exclusion criteria: Key exclusion criteria: insufficient or unclear treatment of the underlying disease (according to the practitioner's judgement), application for retirement/pension pending, on-going psychotherapy, severe, pharmaceutically-treated physical comorbidity (incl., liver and kidney disease, diabetes, hypotension, cancer, blood coagulation disorders), psychiatric comorbidity (inability to consent, suicidality, psychosis spectrum disorders), neurological comorbidity (epilepsy, traumatic brain injury, seizures, multiple sclerosis, neurodegenerative diseases) and pregnancy. For MRI, participants will be excluded if they have implants or metal parts in their body which are not compatible with 3T MRI, or diseases which prevent lying still for 60minutes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain severity between the experimental intervention and the control intervention from T0 to T1 (MPI-D pain severity scale). All analyses are explorative as this is a feasibility study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The exploratory analysis of the data will select the following candidate endpoints: 1. Pain severity (MPI-D) during the last weeks. 2. Disability/quality of life (Short Form-12, SF-12 in the last 4 weeks; Oswestry Disability Index, ODI at the moment). 3. Anxiety and depression (Hospital Anxiety and Depression Scale, HADS) during the last week. 4. The Positive and Negative Affect Schedule (PANAS) during the last 7 days 5. Patient’s global impression of change (PGIC) and Therapists’s global impression of change (TGIC). 6. Days out of work (socioeconomic aspect) and change in medication. 7. Activity levels based on EMA sampling. Feasibility and safety outcomes will be documented and reported comparatively 8. Rate of recruitment, retention and adherence 9. Negative treatment effects (NEQ supplemented by INEQ subscales for negative effects on working place, partnership and family/peers). 10. Severe adverse events (SAEs) will be documented and reported descriptively For endpoints 1-6, the change between T0 and T1 (or 3 month follow-up) will be used as the outcome variable. In addition, the candidate endpoint domains will be investigated after 4 and 8 weeks to explore temporal therapy effects and dose-response relationships. | — |
Countries
Germany
Outcome results
None listed