Fragmented Sleep, Pain, and Biomechanics

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336109
• Other study ID #: N-20220063-3
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Aalborg University
• Contact: Emma Hertel
• Phone: +4560887473
• Email: eh[@]hst.aau.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Healthy
• Pain
• Parasomnias
• Sleep Disturbance

Intervention

Other:
• Hypertonic 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.

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg	Nordjylland

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Level of rest (NRS 0-100)	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)
Primary	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)
Primary	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)
Secondary	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)
Secondary	The Pittsburgh Sleep Quality Index score	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)