Healthy, Pain, Sleep Disturbance
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERHypertonic saline knee and shoulder injection
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.
Sponsors
Aalborg University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Pain intensity (NRS 0-10) | 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' |
| Shoulder Pain intensity (NRS 0-10) | 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
| Measure | Time frame | Description |
|---|---|---|
| The Pittsburgh Sleep Quality Index score | 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. |
| The Pain catastrophizing Scale score | 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. |
| The Hospital Anxiety and Depression Scale score | 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. |
| Rapid Assessment of Physical Activity score | 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. |
| Pain distribution by number of pixels marked on a body chart | 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. |
| Video-based motion capture | 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. |
| The Knee injury and Osteoarthritis Outcome Score | 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. |
| Pain sensitivity | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of sleep (NRS 0-100) | 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'. |
| Level of rest (NRS 0-100) | 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' |
Countries
Denmark
Outcome results
None listed