Clinical trial NCT06411197: Exploration of Gait Biomechanics and Muscle Pain of the Lower Extremity
Official title: Exploration of Gait Biomechanics and Muscle Pain of the Lower Extremity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Acute
Keywords: Musculoskeletal pain
Healthy Participants
Biomechanics
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Healthy men and women aged 18-45 years

Exclusion Criteria:

* 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

Primary outcomes:
measure: Infrared marker XYZ coordinates
timeFrame: Baseline.
measure: Pain intensity (NRS 0-10)
timeFrame: Baseline.
Secondary outcomes:
measure: Pain sensitivity.
timeFrame: Baseline.
measure: Ground reaction forces
timeFrame: Baseline.
measure: Ground reaction moments
timeFrame: Baseline.
measure: Ground contact XZ location
timeFrame: Baseline.
measure: Muscle activation
timeFrame: Baseline.
Other outcomes:
measure: Pain during jumping
timeFrame: Baseline
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
state: Nordjylland
Study officials:
affiliation: Aalborg University
name: Kristian KS Petersen
role: PRINCIPAL_INVESTIGATOR
References: