Fragmented Sleep, Pain, and Biomechanics

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Healthy; Sleep Disturbance
• Intervention / Treatment: Other: Hypertonic saline knee and shoulder injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma Hertel; Phone Number: +4560887473; Email: eh@hst.aau.dk
• Study Contact Backup: Name: Kristian KS Petersen; Phone Number: +4531697510; Email: kkp@hst.aau.dk

Study Locations

• Denmark
  • Nordjylland
    • Aalborg, Nordjylland, Denmark, 9000
      • Recruiting
      • Aalborg University
      • Contact: Kristian K Petersen, Dr. Med; Phone Number: (+45) 31697510; Email: kkp@hst.aau.dk
      • Contact: Emma Hertel, M. Sc.; Phone Number: (+45) 60887473; Email: eh@hst.aau.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Knee Pain and Shoulder Pain; Injection to the infrapatellar fat pad. Will always be administered first. Injection to the deltoid muscle. Will always be administered last.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)
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)
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)
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)
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)

Other Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: Aalborg University
• Investigators: Principal Investigator: Kristian KS Petersen, Aalborg University

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: N-20220063-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No