The Impact of Pain on Behavioural Disturbances in Patients with Moderate and Severe Dementia. A Cluster Randomized Trial, 2010

Worldwide, 24 mill. people have dementia (70000 in Norway) with expected doubling in 30 years. The prevalence of dementia in nursing homes (NH) is 80%, often (60%-80%) combined with behavioural/psychiatric disturbances (BPSD). Additionally, about 80% of NH-patients have pain, which seems to increase BPSD. Caused by absent self-report capacity, patients are underdiagnosed,-treated for pain, often with high use of antipsychotic drugs. For patients, families, and caregivers, this burden is eminent.

Study 1: Association between BPSD and pain. Cluster trial design. 1a) 240 patients (moderate/severe dementia) from 8 NHs, Bergen/Stavanger. Diagnoses by: ICD-10, DSM-IV, CT/fMRI, blood, MMSE, CDR, ADL. Outcome measures: Pain diagnoses/etiology/location/duration, MOBID-2, VRS, NRS, CMAI, NPI. 1b) Annually follow up study (mild/moderate dementia) including 200 patients from DemVest (2006-2008). Outcome measures: NRS, MOBID-2, NPI, MADRS.

Study 2: Pain management effect on BPSD. Randomized rater-blinded study. Patients (study 1a) receive psychosocial care, treatment of physical, psychiatric disorders. Intervention group receive optimal analgesic based on MOBID-2. Control group without specific focus on pain. Effect measurement: CMAI, NPI, MOBID-2, MMSE, ADL. Rating of BPSD performed blind to pain measurements (baseline, week 4, 8).

Study 3: fMRI study 14 communicative patients (mild/moderate dementia) and chronic pain. Control group: 14 age- and sex-matched patients with dementia without pain. Triple random staircaseprocedure with mechanical pressure on to patients` thumbnail.

Study 4: Genetics of pain and dementia. About 540 patients will be tested for genetics regarding haplotypes of 25-50 candidate genes.