PainNCT06336109
Fragmented Sleep, Pain, and Biomechanics
A study testing Hypertonic saline knee and shoulder injection in people with Pain and Healthy, run by Aalborg University at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Healthy, Sleep Disturbance
- What is being tested?
- Hypertonic saline knee and shoulder injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Jan 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women aged 18-45 years
- Must have a smartphone available during the experiment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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.
Read the 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.
- Conditions
- Pain, Healthy, Sleep Disturbance
- Being tested
- Hypertonic saline knee and shoulder injection
- Medical subject headings
- Pain, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic saline knee and shoulder injectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Hypertonic saline knee and shoulder injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: 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'
Measured: Baseline (day 1) and follow-up (day 4)
Secondary outcomes (8)
Pain sensitivity
Cuff-pressure algometry will be used to estimate pressure detection and tolerance thresholds, temporal summation of pain, and conditioned pain modulation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (day 1) and follow-up (day 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start26 Jan 2024
- Primary completion1 Apr 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristian Kjær Petersen, Aalborg University
- Investigators
- Kristian KS Petersen, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336109
- Sponsor's protocol ID
- N-20220063-3
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impacts of Fragmented Sleep on Biomechanics and Pain of the Shoulder and Knee
- ClinicalTrials.gov ID
- NCT06336109
- Acronym / sponsor ID
- N-20220063-3
- Conditions
- Pain, Healthy, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Knee Pain and Shoulder Pain | Experimental | Other: Hypertonic saline knee and shoulder injectionInjection to the infrapatellar fat pad. Will always be administered first. Injection to the deltoid muscle. Will always be administered last. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women aged 18-45 years
- Must have a smartphone available during the experiment
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertonic saline knee and shoulder injection0.25 mL injection with hypertonic saline (7%) in the infrapatellar fat pad. 1.2 mL injection with hypertonic saline (7%) in the deltoid muscle. | Other | Experimental Knee Pain and Shoulder Pain |
Primary outcome
Knee Pain intensity (NRS 0-10)
Time frame: 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)
Time frame: 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'
8 secondary outcomes
Pain sensitivity
Time frame: Baseline (day 1) and follow-up (day 4)
The Pittsburgh Sleep Quality Index score
Time frame: Baseline (day 1) and follow-up (day 4)
The Pain catastrophizing Scale score
Time frame: Baseline (day 1) and follow-up (day 4)
The Hospital Anxiety and Depression Scale score
Time frame: Baseline (day 1) and follow-up (day 4)
The Knee injury and Osteoarthritis Outcome Score
Time frame: Baseline (day 1) and follow-up (day 4)
Rapid Assessment of Physical Activity score
Time frame: Baseline (day 1) and follow-up (day 4)
Pain distribution by number of pixels marked on a body chart
Time frame: Baseline (day 1) and follow-up (day 4)
Video-based motion capture
Time frame: Baseline (day 1) and follow-up (day 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristian KS Petersen principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertonic saline knee and shoulder injection in people with Pain and Healthy, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Pain intensity (NRS 0-10) (time frame: Baseline (day 1) and follow-up (day 4)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.