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NCT Number: NCT06411197

Exploration of Gait Biomechanics and Muscle Pain of the Lower Extremity

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypertonic saline injection

Other

Injection with hypertonic saline (7%)

Isotonic saline injection

Other

Injection with isotonic saline (0.9%)

Primary outcomes

  1. 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 millimeters. Reflective markers will be placed from head-to-toe on anatomical landmarks.

  2. Pain intensity (NRS 0-10)

    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'

Secondary outcomes

  1. 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.

  2. Ground reaction forces

    Time frame: Baseline.

    Ground reaction forces will be measured in Newtons with force plates embedded in the floor.

  3. Ground reaction moments

    Time frame: Baseline.

    Ground reaction moments will be measured in Newton-meters with force plates embedded in the floor.

  4. Ground contact XZ location

    Time frame: Baseline.

    Ground contact XZ coordinate location will be measured in millimeters with force plates embedded in the floor.

  5. Muscle activation

    Time frame: Baseline.

    Muscle activation will be measured in micro-volts using wireless EMG on the muscles of the lower extremities.

Other outcomes

  1. Pain during jumping

    Time frame: Baseline

    Pain during jumping is captured on a numeric rating scale from 0 'no pain' to 10 'the worst pain imaginable'

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Hertel

CONTACT

[email protected]

60887473

Kristian KS Petersen

CONTACT

[email protected]

31697510

Sponsors and collaborators

Lead sponsor

Kristian Kjær Petersen

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 13, 2024
Registry last updated
Oct 2, 2025

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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