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Completed

NCT Number: NCT06336109

Fragmented Sleep, Pain, and Biomechanics

This interventional study aims to test the effects of sleep disruption on pain sensitivity and biomechanics in healthy individuals during experimental knee and shoulder pain. The main question the study aims to answer is:

1) Does sleep fragmentation increase experimental knee and shoulder pain and what are the underlying mechanisms?

Participants will receive two injections a) Hypertonic saline (painful) in the knee and b) hypertonic saline (painful) in the upper arm.

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Key information

Conditions

Pain Healthy Mental Disorders Nervous System Diseases Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disturbance Sleep Wake Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University

Aalborg, North Denmark, 9000, Denmark

About this study

This study will include healthy participants for one baseline session and one follow-up session separated by three nights of experimental sleep disruption.

The sleep fragmentation will involve three forced awakenings per night for three consecutive nights between sessions. These awakenings will be planned at 00:00, 02:30, and 05:00.

In each session, the participant will answer questionnaires and have their pain sensitivity assessed using cuff-pressure algometry. Following this, they will first receive a painful saline injection into the infrapatellar fat pad of the knee. After a washout period, they will receive another painful saline injection into the deltoid muscle of the shoulder. For both injections, the pain will be rated on an NRS scale (0 representing 'no pain' and 10 representing 'worst pain imaginable') every 30 seconds, and the distribution will be marked on a body chart.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy men and women aged 18-45 years
  • Must have a smartphone available during the experiment

Exclusion criteria

  • Pregnancy
  • Drug addiction, defined as the use of cannabis, opioids, or other drugs
  • Previous or current neurologic or musculoskeletal illnesses
  • Current pain
  • Lack of ability to cooperate

Treatment and study plan

Hypertonic saline knee and shoulder injection

Other

0.25 mL injection with hypertonic saline (7%) in the infrapatellar fat pad.

1.2 mL injection with hypertonic saline (7%) in the deltoid muscle.

Primary outcomes

  1. Knee Pain intensity (NRS 0-10)

    Time frame: Baseline (day 1) and follow-up (day 4)

    Pain during intervention is measured continuously every 30 seconds on a numeric rating scale from 0 'no pain' to 10 'the worst pain imaginable'

  2. Shoulder Pain intensity (NRS 0-10)

    Time frame: Baseline (day 1) and follow-up (day 4)

    Pain during intervention is measured continuously every 30 seconds on a numeric rating scale from 0 'no pain' to 10 'the worst pain imaginable'

Secondary outcomes

  1. Pain sensitivity

    Time frame: Baseline (day 1) and follow-up (day 4)

    Cuff-pressure algometry will be used to estimate pressure detection and tolerance thresholds, temporal summation of pain, and conditioned pain modulation.

  2. The Pittsburgh Sleep Quality Index score

    Time frame: Baseline (day 1) and follow-up (day 4)

    19 items summarized to a single score ranging from zero to 21 with higher scores reflecting worse quality of sleep.

  3. The Pain catastrophizing Scale score

    Time frame: Baseline (day 1) and follow-up (day 4)

    13 items summarized to a single score ranging from zero to 52 with higher scores reflecting more catastrophizing.

  4. The Hospital Anxiety and Depression Scale score

    Time frame: Baseline (day 1) and follow-up (day 4)

    14 items summarized into two 7-item subscales measuring symptoms of anxiety and depression. Each subscale score ranges from zero to 21 with higher scores reflecting more severe symptoms.

  5. The Knee injury and Osteoarthritis Outcome Score

    Time frame: Baseline (day 1) and follow-up (day 4)

    42 items divided into five subscales: pain (9 items), activities of daily living (17 items), sport and recreation function (5 items), knee-related quality of life (4 items), and other symptoms (7 items). Each subscale is scored from zero to 100 with higher scores reflecting increased severity of knee problems.

  6. Rapid Assessment of Physical Activity score

    Time frame: Baseline (day 1) and follow-up (day 4)

    9 items scored into summarized categories of either: Sedentary; under-active; under-active regular - light activities; under-active regular; or active.

  7. Pain distribution by number of pixels marked on a body chart

    Time frame: Baseline (day 1) and follow-up (day 4)

    Area marked with pen will be computed into a score of the ratio of pixels marked compared to the total pixels on the body chart.

  8. Video-based motion capture

    Time frame: Baseline (day 1) and follow-up (day 4)

    Video recordings of the participant will be obtained, and will later be processed using machine learning to evaluate the gait pattern.

Other outcomes

  1. Quality of sleep (NRS 0-100)

    Time frame: Baseline (day 1), day 2, day 3 and follow-up (day 4)

    Quality of sleep will be rated from 0 'worst quality imaginable' to 100 'best quality imaginable'.

  2. Level of rest (NRS 0-100)

    Time frame: Baseline (day 1), day 2, day 3 and follow-up (day 4)

    Level of rest will be rated from 0 'not rested at all' to 100 'most rest possible'

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

The Impacts of Fragmented Sleep on Biomechanics and Pain of the Shoulder and Knee

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 28, 2024
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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