Aalborg University
Aalborg, North Denmark, 9000, Denmark
Location status: Recruiting
Location contact
Emma Hertel
CONTACT
Kristian KS Petersen
CONTACT
NCT Number: NCT06411197
This interventional study aims to test gait biomechanics in healthy individuals with and without experimental muscle pain in the lower extremities. The study aims to:
A) Examine how experimental muscle pain in different types of muscles (ankle plantar-flexion, knee extension, and flexion muscles) affects kinematics, kinetics, and muscle activation
Participants will receive six muscle injections: a) Hypertonic saline (painful condition) and b) Isotonic saline (control condition) in 1) m. gastrocnemius, 2) m. semitendinosus, and 3) m. biceps femoris.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Not applicable
Aalborg, North Denmark, 9000, Denmark
Location status: Recruiting
Emma Hertel
CONTACT
Kristian KS Petersen
CONTACT
The proposed study will be a randomized, crossover design in which experimental pain will be induced in healthy subjects using hypertonic saline injections to three muscles of the lower extremities: The gastrocnemius muscle, the vastus medialis muscle, and the semitendinosus muscle. Participants will be block-randomized to receive an injection in each of the three muscles and will receive either the painful or control condition first for each muscle. The participant will always be blinded to the type of injection received.
Following the injection, there will typically be a 15-minute window of pain (45). Within this timeframe, motion capture will be carried out for both the control and painful conditions. During motion capture, the participants will perform multiple walking trials of approximately 10 meters. The participants will be equipped with electromyography (EMG) sensors on key muscles of the lower extremities. The participants will be asked for NRS ratings every 30 seconds throughout the 15 minutes with expected pain. There will be a 15-minute washout between the muscle injections.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Injection with hypertonic saline (7%)
Injection with isotonic saline (0.9%)
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 millimeters. Reflective markers will be placed from head-to-toe on anatomical landmarks.
Time frame: Baseline.
Pain during intervention is measured continuously every 30 seconds on a numeric rating scale from 0 'no pain' to 10 'the worst pain imaginable'
Time frame: Baseline.
Cuff-pressure algometry will be used to estimate pressure detection and tolerance thresholds, temporal summation of pain, and conditioned pain modulation.
Time frame: Baseline.
Ground reaction forces will be measured in Newtons with force plates embedded in the floor.
Time frame: Baseline.
Ground reaction moments will be measured in Newton-meters with force plates embedded in the floor.
Time frame: Baseline.
Ground contact XZ coordinate location will be measured in millimeters with force plates embedded in the floor.
Time frame: Baseline.
Muscle activation will be measured in micro-volts using wireless EMG on the muscles of the lower extremities.
Time frame: Baseline
Pain during jumping is captured on a numeric rating scale from 0 'no pain' to 10 'the worst pain imaginable'
Contact information is provided by the study sponsor or research team.
Emma Hertel
CONTACT
Kristian KS Petersen
CONTACT
Kristian Kjær Petersen
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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