Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT06330402
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2024-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploration of Gait Biomechanics and Pain
Sponsor:
Kristian Kjær Petersen
Organization:
Study Overview
Official Title:
Undersøgelse af sammenhængen Mellem Biomekanik og Smerter Ved Gang
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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?
Participants will receive two knee injections: a) Hypertonic saline (painful condition) and b) Isotonic saline (control condition).
* 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: