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Chronic PainNCT04649281

Insomnia and Sleep Disturbances in Chronic Pain Patients - Relation to Physical Activity Level and Opioid Use

A study testing Accelerometry in people with Chronic Pain and Insomnia, run by Göteborg University at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Pain is one of the most common causes of healthcare contact and long-term sick leave, with negative consequences on physical and mental health. Poor sleep is common in chronic pain patients. Epidemiological studies indicate that 5-7% of patients with chronic pain are treated regularly with strong opioids. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain, Insomnia, Exercise
What is being tested?
Accelerometry
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSweden
Study dates
12 Oct 2020to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic pain (i.e. pain > 3 months)
  • Planned follow up at the Pain Centre
  • Age ≥18 years
  • Consents to participation in the study

Who cannot join

  • Inadequate knowledge of the Swedish language
  • Alcohol or substance abuse
  • Severe untreated psychiatric disorders including psychiatric disease and/or psychological conditions which are the primary determinant to the patient's pain condition
  • Malignant disease with short expected survival

Trial locations and contacts

1 site in 1 country.

Paulin Andréll, MD, PhD contact

+46-31-3438259

paulin.andrell@gu.se

Martin Olsson, MD contact

+46-31-3435816

martin.olsson@gu.se

Sweden1 site, 1 recruiting

  • Pain Centre, Department of Anaesthesiology and Intensive Care Medicine Östra, Sahlgrenska University Hospital, Region Västra Götaland

    Gothenburg

    Paulin Andréll, MD, PhD

    Martin Olsson, MD

    Recruiting

Other trials in Sweden

About this study

Pain is one of the most common causes of healthcare contact and long-term sick leave, with negative consequences on physical and mental health. Poor sleep is common in chronic pain patients. Epidemiological studies indicate that 5-7% of patients with chronic pain are treated regularly with strong opioids. Negative side effects of pain modulating drugs on sleep quality have been reported, which may have negative influence on overall disease management in chronic pain patients. However, to date there are conflicting results regarding the effects of opioids on sleep, since the pain relieving effect of opioids seem to affect sleep positively. There is data suggesting that physical activity has positive effects on both pain perception and sleep quality (and duration). The aim of the study is to explore insomnia and characteristics of sleep in patients with chronic pain and the relationship with physical activity level and opioid use.

Read the detailed description

One hundred participants with planned follow-up (decision according to clinical routine) at the Pain Centre will be consecutively recruited. After signed informed consent, the participants will wear two accelerometers during one week, one for recording sleep and one for recording physical activity. The participants will be asked to fill out a sleep and pain diary during the same week. Furthermore, the participants will fill out questionnaires regarding sleep, life style, mental fatigue and self-efficacy. All study participant are included in the Swedish Quality Registry for Pain Rehabilitation (SQRP). Data from the SQRP will be used regarding patient health characteristics, pain and pain associated symptoms, health related quality of life, sleep and self-reported physical activity level. Data regarding co-morbidity, drug use, pharmacological treatment and other interventions at the Pain Center will be collected from the patient charts. In addition, the participants blood pressure and neck circumference will be measured. Blood samples will be analysed for biomarkers associated with pain and sleep disturbance.

Being tested
Accelerometry
Keywords
Accelerometry, Mental fatigue, Self-Efficacy
Medical subject headings
Chronic Pain, Sleep Initiation and Maintenance Disorders, Motor Activity, Sleep Wake Disorders, Mental Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AccelerometryDevice

    Recording of sleep and physical activity by accelerometry during one week.

Study groups in NCT04649281
Study groupRoleWhat they receive
AccelerometryOtherRecording of sleep and physical activity by accelerometry during one week.
Receives: Device: Accelerometry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep

    Sleep duration in minutes assessed by accelerometry

    Measured: Daily assessment during one week

  2. Sleep

    Sleep timing, i.e. sleep onset and wake time assessed by accelerometry

    Measured: Daily assessment during one week

  3. Physical activity

    Minutes of physical activity per week at moderate and vigorous intensity physical activity (MVPA), minutes of sedentary behaviour (SED) assessed by accelerometry

    Measured: Daily assessment during one week

  4. Opioid consumption

    Opioid consumption in morphine equivalent doses

    Measured: Opioid consumption at study enrollment

  5. Pain intensity

    Pain intensity according to Numeric Rating Scale (NRS), score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable"

    Measured: Daily assessment during one week

Secondary outcomes (7)

  1. Insomnia Severity

    Total Score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.

    Measured: Insomnia severity at enrollment

  2. Sleep quality

    Assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-rated questions which assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep related problems. The 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component score are then summed to yield a global PSQI score which has a range of 0-21; higher scores indicate worse sleep quality.

    Measured: Sleep quality at study enrollment

  3. Daytime sleepiness

    Epworth Sleepiness Scale (ESS), which quantifies daytime sleepiness. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher daytime sleepiness.

    Measured: Daytime sleepiness at study enrollment

  4. Self-assessed physical activity

    Minutes of physical activity per week (physical exercise and daily exercise) and minutes of sedentary behaviour per week.

    Measured: Self-assessed physical activity at study enrollment

  5. Self-efficacy for exercise scale

    The Self-efficacy for exercise scale measures a patient's self-efficacy when it comes to physical exercise. The questionnaire consists of 9 questions that can be answered on a 1-10 scale. A total score between 9 and 90 is calculated, were a higher number represent a better outcome.

    Measured: Self-efficacy for exercise at study enrollment

  6. Mental fatigue scale

    The mental fatigue scale (MFS) is a multidimensional questionnaire containing 15 questions. A total score between 0-42 is calculated. A score >10 indicates a problem with mental fatigue.

    Measured: Mental fatigue at study enrollment

  7. Sleep dairy

    Self-assessed sleep latency, total sleep time, wake time after sleep onset and sleep quality.

    Measured: Daily assessment during one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2020
  2. Study start12 Oct 2020
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04649281
Sponsor's protocol ID
272924
Status last verified
Nov 2020
First submitted
28 Oct 2020
Last updated
2 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Varkey E, Olsson M, Piasecki A, Hedner J, Grote L, Borjesson M, Arvidsson D, Andrell P. Sleep-Wake Disturbances in Patients With Chronic Pain-Associations With Physical Activity Levels. Eur J Pain. 2026 Jul;30(6):e70330. doi: 10.1002/ejp.70330.

    PubMed 42410897

Questions about this trial

What is this clinical trial studying?

A study testing Accelerometry in people with Chronic Pain and Insomnia, run by Göteborg University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Paulin Andréll, MD, PhD (+46-31-3438259, paulin.andrell@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep (time frame: Daily assessment during one week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04649281, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.

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