Clinical trial NCT06336109: Fragmented Sleep, Pain, and Biomechanics
Official title: The Impacts of Fragmented Sleep on Biomechanics and Pain of the Shoulder and Knee
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Healthy
Sleep Disturbance
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Pain intensity (NRS 0-10)
timeFrame: Baseline (day 1) and follow-up (day 4)
measure: Shoulder Pain intensity (NRS 0-10)
timeFrame: Baseline (day 1) and follow-up (day 4)
Secondary outcomes:
measure: Pain sensitivity
timeFrame: Baseline (day 1) and follow-up (day 4)
measure: The Pittsburgh Sleep Quality Index score
timeFrame: Baseline (day 1) and follow-up (day 4)
measure: The Pain catastrophizing Scale score
timeFrame: Baseline (day 1) and follow-up (day 4)
measure: The Hospital Anxiety and Depression Scale score
timeFrame: Baseline (day 1) and follow-up (day 4)
measure: The Knee injury and Osteoarthritis Outcome Score
timeFrame: Baseline (day 1) and follow-up (day 4)
measure: Rapid Assessment of Physical Activity score
timeFrame: Baseline (day 1) and follow-up (day 4)
measure: Pain distribution by number of pixels marked on a body chart
timeFrame: Baseline (day 1) and follow-up (day 4)
measure: Video-based motion capture
timeFrame: Baseline (day 1) and follow-up (day 4)
Other outcomes:
measure: Quality of sleep (NRS 0-100)
timeFrame: Baseline (day 1), day 2, day 3 and follow-up (day 4)
measure: Level of rest (NRS 0-100)
timeFrame: Baseline (day 1), day 2, day 3 and follow-up (day 4)
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
state: Nordjylland
Study officials:
affiliation: Aalborg University
name: Kristian KS Petersen
role: PRINCIPAL_INVESTIGATOR
References: