Chronic Pain, Low Back Pain, Migraine Disorder, Sleep Disorder (Disorder)
Conditions
Keywords
Sleep Quality, Sleep Hygiene, Pain Sensitivity
Brief summary
The goal of this clinical trial is to learn whether sleep hygiene education can improve sleep quality and reduce pain in adults with migraine and/or chronic lower back pain. Poor sleep is common in people with chronic pain and may worsen symptoms. Improving sleep may help break this cycle. The main questions this study aims to answer are: 1. Does a four-week sleep hygiene education program improve sleep quality? 2. Does improved sleep lead to reduced pain intensity and changes in pain sensitivity? This study does not include a comparison group. Each participant serves as their own comparison by completing the same tests before and after the sleep hygiene program. Participants will: * Attend two study visits lasting 30-60 minutes, one at the beginning and one after four weeks * Complete questionnaires about sleep, pain, mood, and quality of life at both visits * Undergo pain sensitivity testing using light pinprick stimulations on the forearm * Receive individual sleep hygiene education and written materials to use at home for four weeks * Complete a short weekly online check-in about sleep habits and pain * Complete a three-month follow-up questionnaire about sleep habits, sleep quality, and pain
Interventions
BEHAVIORALSleep Hygiene Education
The intervention consists of a structured and standardized sleep hygiene education program delivered in a single in-person session. Participants receive verbal instruction and written materials outlining evidence-based recommendations for improving sleep habits. The content focuses on establishing consistent bedtimes and wake times, creating a good sleep environment, reducing evening exposure to stimulants and electronic devices, developing calming nighttime routines, and adopting healthy daytime behaviors. Participants implement these strategies independently for four weeks.
Sponsors
Aalborg University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic back pain (average pain VAS ≥ 3) AND/OR Migraine (migraine or tension headaches ≥15 days per month with ≥8 days being migraine) * Lasting ≥3 months * Adults ≥18 years old * Read, speak, and understand Danish * Willing to implement sleep hygiene for four weeks * Digital competencies (sufficient to answer questionnaires online)
Exclusion criteria
* Pregnancy * Drug addiction, defined as the use of cannabis, opioids, or other drugs * Malignant comorbidity (e.g., cancer) * Neurological conditions affecting cognition (e.g., multiple sclerosis, epilepsy, dementia, previous stroke/transient cerebral ischemia) * Intake of acute headache medication on ≥15 days/month for simple analgesics/NSAIDs or ≥10 days/month for triptans, ergotamine, opioids, or combinations thereof over 3 months. * Use of unstable sleep-modulating pharmacological treatment (e.g., melatonin, tricyclic antidepressants) * Diagnosed sleep disorder (e.g., insomnia, narcolepsy, sleep apnoea) * Night-shift work * Initiation of any new therapy during the study period * The subject is assessed as unable to engage in the necessary cooperation required by the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Quality (PSQI Global Score) | Baseline (Visit 1) to 4 weeks (Visit 2) | Sleep quality is measured using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire summarized into a global sleep quality score (0-21). Higher scores indicate poorer sleep quality. The primary outcome is the change in PSQI global score after four weeks of sleep hygiene education. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Hygiene Behaviors (Sleep Hygiene Index, SHI) | Baseline (Visit 1) to 4 weeks (Visit 2); Week 1; Week 2; Week 3; 3-month follow-up | Sleep hygiene behaviors are measured using the Sleep Hygiene Index (SHI), which assesses engagement in behaviors that negatively impact sleep. Higher scores reflect poorer sleep hygiene. Changes across time points will be assessed. |
| Change in Temporal Summation of Pain (Pinprick Sensitivity Test) | Baseline (Visit 1) to 4 weeks (Visit 2) | Temporal summation is assessed using a standardized pinprick protocol on the volar forearm. Participants provide pain ratings for a single stimulus and for the last of 10 consecutive stimuli. The outcome is the change in temporal summation response. |
| Change in PainDetect | Baseline (Visit 1) to 4 weeks (Visit 2) | PainDetect assesses neuropathic and centrally mediated pain components. Higher scores indicate a higher likelihood of central sensitization. |
| Change in Headache Impact (HIT-6) - for migraine participants only | Baseline (Visit 1) to 4 weeks (Visit 2) | The HIT-6 assesses the functional impact of headaches. Higher scores indicate greater impairment. |
| Long-Term Maintenance of Sleep Hygiene Index, SHI | 4 weeks (Visit 2) to 3-month post-intervention follow-up (remote) | Assessed via an online questionnaire evaluating whether changes in SHI scores persist three months after the intervention period. Higher scores reflect poorer sleep hygiene adherence. |
| Long-Term Maintenance of PSQI | 4 weeks (Visit 2) to 3-month post-intervention follow-up (remote) | Assessed via an online questionnaire evaluating whether changes in PSQI persist three months after the intervention period. Higher scores indicate poorer quality of sleep. |
| Long-Term Pain Intensity Measure - PainDetect | 4 weeks (Visit 2) to 3-month post-intervention follow-up (remote) | Assessed via an online questionnaire evaluating whether changes in PainDetect scores persist three months after the intervention period. Higher scores indicate a higher likelihood of central sensitization. |
| Long-Term Maintenance of Headache Impact (HIT-6) - for migraine participants only | 4 weeks (Visit 2) to 3-month post-intervention follow-up (remote) | Assessed via an online questionnaire evaluating whether changes in HIT-6 persist three months after the intervention period. Higher scores indicate greater impairment. |
Contacts
CONTACTKristian Kjær-Staal Petersen
CONTACTEmma Hertel
Outcome results
None listed