PainNCT06330402
Exploration of Gait Biomechanics and Pain
A study testing Hypertonic saline injection and Isotonic saline injection in people with Pain and Healthy, run by Kristian Kjær Petersen at 1 site in Denmark.
Trial summary
This interventional study aims to test gait biomechanics in healthy individuals with and without experimental knee pain. The main questions it aims to answer are: How do gait patterns change during painful walking? Can pain sensitivity testing and gait biomechanics predict experimental knee pain intensity?… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Hypertonic saline injection and Isotonic saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Sep 2023to 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
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: Undersøgelse af sammenhængen Mellem Biomekanik og Smerter Ved Gang
This interventional study aims to test gait biomechanics in healthy individuals with and without experimental knee pain. The main questions it aims to answer are:
- How do gait patterns change during painful walking?
- Can pain sensitivity testing and gait biomechanics predict experimental knee pain intensity?
Participants will receive two knee injections: a) Hypertonic saline (painful condition) and b) Isotonic saline (control condition).
Read the detailed description
This study will be a randomized, crossover design where experimental knee pain will be provoked in healthy subjects using hypertonic saline injections to the infrapatellar fat pad (IFP). This will be controlled with a second injection of isotonic saline, which is non-painful. The participants will not be informed of the type of injection.
Hypertonic saline injections to the IFP usually provoke pain lasting about 15 minutes. Within this timeframe, motion capture will be conducted to estimate the biomechanics of gait. During the motion capture the participants will perform five 10-meter walking trials and three jumps. This process will be replicated for the control condition.
Additionally, the participants will have their pain sensitivity tested using cuff-pressure algometry before both IFP injections.
- Being tested
- Hypertonic saline injection, Isotonic saline injection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic saline injectionOther
0.25 mL injection with hypertonic saline (7%) to the infrapatellar fat pad.
Isotonic saline injectionOther
Control injection with 0.25 mL isotonic saline (0.9%) to the infrapatellar fat pad.
| Study group | Role | What they receive |
|---|---|---|
| Painful condition | Experimental | Hypertonic saline injection to the infrapatellar fat pad. Receives: Other: Hypertonic saline injection |
| Control condition | Placebo comparator | Isotonic saline injection to the infrapatellar fat pad. Receives: Other: Isotonic saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infrared marker XYZ coordinates
Marker-based motion capture with infrared cameras will be used to estimate placement of reflective markers in the XYZ planes measured in milimeters. Reflective markers will be placed from head-to-toe on anatomical landmarks.
Measured: Baseline
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
Secondary outcomes (8)
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
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
The Hospital Anxiety and Depression Scale
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
Knee symptoms
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 score from zero to 100 with higher scores reflecting increased severity of knee problems.
Measured: Baseline
Ground reaction forces
Ground reaction forces will be measured in Newton-meters with force plates embedded in the floor.
Measured: Baseline
Ground reaction moments
Ground reaction moments will be measured in Newton-meters with force plates embedded in the floor.
Measured: Baseline
Ground contact XZ location
Ground contact XZ coordinate location will be measured in milimeters with force plates embedded in the floor.
Measured: Baseline
Muscle activation
Muscle activation will be measured in micro-volts using wireless EMG on the muscles of the lower extremities.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start26 Sep 2023
- Primary completion1 Feb 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristian Kjær Petersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristian Kjær Petersen, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330402
- Sponsor's protocol ID
- N-20220063
- Status last verified
- Sep 2025
- First submitted
- 12 Mar 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Undersøgelse af sammenhængen Mellem Biomekanik og Smerter Ved Gang
- ClinicalTrials.gov ID
- NCT06330402
- Acronym / sponsor ID
- N-20220063
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Kristian Kjær PetersenUniversity, hospital or other
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 26 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 gait biomechanics in healthy individuals with and without experimental knee pain. The main questions it aims to answer are:
- How do gait patterns change during painful walking?
- Can pain sensitivity testing and gait biomechanics predict experimental knee pain intensity?
Participants will receive two knee injections: a) Hypertonic saline (painful condition) and b) Isotonic saline (control condition).
Detailed description
This study will be a randomized, crossover design where experimental knee pain will be provoked in healthy subjects using hypertonic saline injections to the infrapatellar fat pad (IFP). This will be controlled with a second injection of isotonic saline, which is non-painful. The participants will not be informed of the type of injection.
Hypertonic saline injections to the IFP usually provoke pain lasting about 15 minutes. Within this timeframe, motion capture will be conducted to estimate the biomechanics of gait. During the motion capture the participants will perform five 10-meter walking trials and three jumps. This process will be replicated for the control condition.
Additionally, the participants will have their pain sensitivity tested using cuff-pressure algometry before both IFP injections.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Painful condition | Experimental | Other: Hypertonic saline injectionHypertonic saline injection to the infrapatellar fat pad. |
| Control condition | Placebo comparator | Other: Isotonic saline injectionIsotonic saline injection to the infrapatellar fat pad. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men and women aged 18-45 years
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 injection0.25 mL injection with hypertonic saline (7%) to the infrapatellar fat pad. | Other | Painful condition |
| Isotonic saline injectionControl injection with 0.25 mL isotonic saline (0.9%) to the infrapatellar fat pad. | Other | Control condition |
Primary outcome
Infrared marker XYZ coordinates
Time frame: Baseline
Marker-based motion capture with infrared cameras will be used to estimate placement of reflective markers in the XYZ planes measured in milimeters. Reflective markers will be placed from head-to-toe on anatomical landmarks.
Pain sensitivity.
Time frame: Baseline
Cuff-pressure algometry will be used to estimate pressure detection and tolerance thresholds, temporal summation of pain, and conditioned pain modulation.
8 secondary outcomes
The Pittsburgh Sleep Quality Index score
Time frame: Baseline
The Pain catastrophizing Scale score
Time frame: Baseline
The Hospital Anxiety and Depression Scale
Time frame: Baseline
Knee symptoms
Time frame: Baseline
Ground reaction forces
Time frame: Baseline
Ground reaction moments
Time frame: Baseline
Ground contact XZ location
Time frame: Baseline
Muscle activation
Time frame: Baseline
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 1 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 injection and Isotonic saline injection in people with Pain and Healthy, run by Kristian Kjær Petersen 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 1 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 1 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. Some participants in this study may receive a placebo. 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?
Infrared marker XYZ coordinates (time frame: Baseline). 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 1 Oct 2025.