Health TrialsbyHealthPanel

Exploration of Gait Biomechanics and Muscle Pain of the Lower Extremity

ConditionPain, Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorKristian Kjær Petersen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy men and women aged 18-45 years

Disqualifiers

Pregnancy

Drug addiction, defined as the use of cannabis, opioids, or other drugs

Previous or current neurologic or musculoskeletal illnesses

Current pain

Trial design

Design model

Crossover

Treatments tested in this trial

  • Hypertonic saline injection

    Other intervention

    Injection with hypertonic saline (7%)

  • Isotonic saline injection

    Other intervention

    Injection with isotonic saline (0.9%)

Treatment groups

36 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Gastrocnemius (painful condition)Experimental treatment 1 intervention
Group B: Gastrocnemius (control condition)Sham comparator 1 intervention
Group C: Biceps femoris (painful condition)Experimental treatment 1 intervention
Group D: Biceps femoris (control condition)Sham comparator 1 intervention
Group E: Semitendinosus (painful condition)Experimental treatment 1 intervention
Group F: Semitendinosus (control condition)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline.
2

Pain intensity (NRS 0-10)

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.

Secondary outcomes

1

Pain sensitivity.

Cuff-pressure algometry will be used to estimate pressure detection and tolerance thresholds, temporal summation of pain, and conditioned pain modulation.

Time frame
Baseline.
2

Ground reaction forces

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

Time frame
Baseline.
3

Ground reaction moments

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

Time frame
Baseline.
4

Ground contact XZ location

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

Time frame
Baseline.

Other outcomes

1

Pain during jumping

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

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kristian Kjær Petersen

Lead sponsor

Aalborg University

Sponsor institution

Source ClinicalTrials.gov
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