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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Knee Pain and Shoulder Pain | Experimental | Injection to the infrapatellar fat pad. Will always be administered first. Injection to the deltoid muscle. Will always be administered last. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Pain intensity (NRS 0-10) | Pain during intervention is measured continuously every 30 seconds on a numeric rating scale from 0 'no pain' to 10 'the worst pain imaginable' | Baseline (day 1) and follow-up (day 4) |
| Shoulder Pain intensity (NRS 0-10) | Pain during intervention is measured continuously every 30 seconds on a numeric rating scale from 0 'no pain' to 10 'the worst pain imaginable' | Baseline (day 1) and follow-up (day 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain sensitivity | Cuff-pressure algometry will be used to estimate pressure detection and tolerance thresholds, temporal summation of pain, and conditioned pain modulation. | Baseline (day 1) and follow-up (day 4) |
| The Pittsburgh Sleep Quality Index score |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of sleep (NRS 0-100) | Quality of sleep will be rated from 0 'worst quality imaginable' to 100 'best quality imaginable'. | Baseline (day 1), day 2, day 3 and follow-up (day 4) |
| Level of rest (NRS 0-100) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristian KS Petersen | Aalborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University | Aalborg | North Denmark | 9000 | Denmark |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012893 | Sleep Wake Disorders |
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19 items summarized to a single score ranging from zero to 21 with higher scores reflecting worse quality of sleep. |
| Baseline (day 1) and follow-up (day 4) |
| The Pain catastrophizing Scale score | 13 items summarized to a single score ranging from zero to 52 with higher scores reflecting more catastrophizing. | Baseline (day 1) and follow-up (day 4) |
| The Hospital Anxiety and Depression Scale score | 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. | Baseline (day 1) and follow-up (day 4) |
| The Knee injury and Osteoarthritis Outcome Score | 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. | Baseline (day 1) and follow-up (day 4) |
| Rapid Assessment of Physical Activity score | 9 items scored into summarized categories of either: Sedentary; under-active; under-active regular - light activities; under-active regular; or active. | Baseline (day 1) and follow-up (day 4) |
| Pain distribution by number of pixels marked on a body chart | 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. | Baseline (day 1) and follow-up (day 4) |
| Video-based motion capture | Video recordings of the participant will be obtained, and will later be processed using machine learning to evaluate the gait pattern. | Baseline (day 1) and follow-up (day 4) |
Level of rest will be rated from 0 'not rested at all' to 100 'most rest possible'
| Baseline (day 1), day 2, day 3 and follow-up (day 4) |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |