Fragmented Sleep, Pain, and Biomechanics

NCT06336109 | Completed

• 1 other identifier: N-20220063-3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Healthy; Sleep Disturbance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Pain sensitivity

  Baseline (day 1) and follow-up (day 4)

• The Pittsburgh Sleep Quality Index score

  Baseline (day 1) and follow-up (day 4)

• The Pain catastrophizing Scale score

  Baseline (day 1) and follow-up (day 4)

• The Hospital Anxiety and Depression Scale score

  Baseline (day 1) and follow-up (day 4)

• The Knee injury and Osteoarthritis Outcome Score

  Baseline (day 1) and follow-up (day 4)

Other Outcomes (2)

• Quality of sleep (NRS 0-100)

  Baseline (day 1), day 2, day 3 and follow-up (day 4)

• Level of rest (NRS 0-100)

  Baseline (day 1), day 2, day 3 and follow-up (day 4)

Study Arms (1)

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.

Other: Hypertonic saline knee and shoulder injection

Interventions

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.

Experimental Knee Pain and Shoulder Pain

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women aged 18-45 years
• Must have a smartphone available during the experiment

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg University

Aalborg, North Denmark, 9000, Denmark

Location

MeSH Terms

Conditions

Pain; Parasomnias

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Kristian KS Petersen

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: January 26, 2024
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 2, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)