Insomnia treatment in patients with musculoskeletal pain seeking physiotherapy in primary care. Musculoskeletal Diseases
Conditions
Interventions
We will conduct a RCT to investigate if patients with common musculoskeletal disorders benefit from adding dCBT-I to usual care compared to usual care only. The setting is private practice physiothera
Sponsors
Norwegian University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 67 years 2. Musculoskeletal pain as the primary reason for seeking physiotherapy 3. Patients must report having insomnia, defined as Insomnia Severity Index (ISI) score of 12 or higher
Exclusion criteria
Exclusion criteria: 1. Reduced cognitive function (dementia, etc) 2. Specific diagnosis such as fractures, neurological conditions (i.e. stroke, multiple sclerosis etc.) 3. Terminal or progressive illness (e.g., cancer) 4. Pre or postoperative patients 5. Pregnancy related disorders 6. Inadequate opportunity to sleep or living circumstances that prevent modification of sleep patterns such as having an infant, currently receiving psychological treatment for insomnia, or working night shifts 7. Not having a smartphone or tablet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported insomnia severity assessed by Insomnia Severity Index (ISI) at 3-month follow-up. ISI is measured at baseline, end of intervention, 3 months, 6-months, and 12-months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, post-intervention, 3 months, 6 months and 12 months: 1. Pain intensity measured using Numerical Rating Scale (0-10) 2. Function, measured by the musculoskeletal health questionnaire (MSK-HQ) 3. Health-related quality of life measured by the EuroCol EQ5D-5L questionnaire 4. Mental distress measured using the Hopkins Check List (HSCL-5) 5. Self-reported use of pain and sleep medication last week 6. Sick leave, medication, and health resource utilization assessed from national health registers. We will also assess these data at 24-month follow-up: 8.1. Overview of health service utilization measured by obtaining data from the Norwegian Patient Registry 8.2. Overview of prescribed medication measured by obtaining data from the Norwegian Prescription Database 8.3. Information on sick leave measured by obtaining data from the National Insurance Administration 7. Cost-effectiveness analysed based on patients' deductibles and costs covered by the Norwegian Health Economics Administration (HELFO) and utility measured by EQ-5D Baseline screening: 8. Ørebro Musculoskeletal Pain Questionnaire (4 questions) 9. Demographics (age, sex, ethnicity, education, marital status, employment status, shift work) measured using single questions for each respective question 10. Comorbidity measured using self-reports of different disorders (e.g., cancer, multiple sclerosis, epilepsy, depression, anxiety, rheumatic disorder, diabetes, asthma, heart failure) 11. Lifestyle (e.g., 3 questions on alcohol consumption and drug use, 3 questions on frequency, intensity, and duration of leisure time physical activity (also measured at 3 months), and self-reported height (cm) and body weight (kg) 12. Chronotype measured using Brief Horne-Østberg Morningness-Eveningness questionnaire 13. Sleep reactivity measured using Ford Insomnia Response to Stress Test 14. Duration of sleep problems, previous treatment of insomnia, sleep-talking, sleepwalking, and possible restless legs/sleep | — |
Countries
Norway
Outcome results
None listed