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Clinical Trials/NCT06330402
NCT06330402
Completed
N/A

Undersøgelse af sammenhængen Mellem Biomekanik og Smerter Ved Gang

Kristian Kjær Petersen1 site in 1 country34 target enrollmentSeptember 26, 2023
ConditionsPainHealthy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain
Sponsor
Kristian Kjær Petersen
Enrollment
34
Locations
1
Primary Endpoint
Infrared marker XYZ coordinates
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

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).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 26, 2023
End Date
September 1, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Kristian Kjær Petersen
Responsible Party
Sponsor Investigator
Principal Investigator

Kristian Kjær Petersen

Principal Investigator

Aalborg University

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

Outcomes

Primary Outcomes

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.

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

  • Ground reaction forces(Baseline)
  • Ground reaction moments(Baseline)
  • The Pittsburgh Sleep Quality Index score(Baseline)
  • The Pain catastrophizing Scale score(Baseline)
  • The Hospital Anxiety and Depression Scale(Baseline)
  • Knee symptoms(Baseline)
  • Muscle activation(Baseline)
  • Ground contact XZ location(Baseline)

Study Sites (1)

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