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Completed

NCT Number: NCT06330402

Exploration of Gait Biomechanics and Pain

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).

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Key information

Conditions

Pain Healthy Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University

Aalborg, North Denmark, 9000, Denmark

About this study

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.

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

0.25 mL injection with hypertonic saline (7%) to the infrapatellar fat pad.

Isotonic saline injection

Other

Control injection with 0.25 mL isotonic saline (0.9%) to the infrapatellar fat pad.

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

  2. 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.

Secondary outcomes

  1. The Pittsburgh Sleep Quality Index score

    Time frame: Baseline

    19 items summarized to a single score ranging from zero to 21 with higher scores reflecting worse quality of sleep.

  2. The Pain catastrophizing Scale score

    Time frame: Baseline

    13 items summarized to a single score ranging from zero to 52 with higher scores reflecting more catastrophizing.

  3. The Hospital Anxiety and Depression Scale

    Time frame: Baseline

    14 items summarized into two 7-item subscales measuring symptoms of anxiety and depression. Each subscale score ranges from zero to 21 with higher scores reflecting more severe symptoms.

  4. Knee symptoms

    Time frame: Baseline

    42 items divided into five subscales: pain (9 items), activities of daily living (17 items), sport and recreation function (5 items), knee-related quality of life (4 items), and other symptoms (7 items). Each subscale is score from zero to 100 with higher scores reflecting increased severity of knee problems.

  5. Ground reaction forces

    Time frame: Baseline

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

  6. Ground reaction moments

    Time frame: Baseline

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

  7. Ground contact XZ location

    Time frame: Baseline

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

  8. 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 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 imagineable'

  2. Pain distribution

    Time frame: Baseline

    Pain during intervention is marked on a body chart

Sponsors and collaborators

Lead sponsor

Kristian Kjær Petersen

Other

Registry information

Official study title

Undersøgelse af sammenhængen Mellem Biomekanik og Smerter Ved Gang

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2024
Registry last updated
Oct 1, 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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