Exploration of Gait Biomechanics and Pain

Not Applicable

Recruiting

• Conditions: Healthy; Pain
• Interventions: Other: Hypertonic saline injection; Other: Isotonic saline injection

• Registration Number: NCT06330402
• Lead Sponsor: Kristian Kjær Petersen

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.

Study Timeline

• Study Start: 2023-09-26
• Status Verified: 2024-03
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-26
• Last Update Posted: 2024-03-26
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Painful condition	Hypertonic saline injection	Hypertonic saline injection to the infrapatellar fat pad.
Control condition	Isotonic saline injection	Isotonic saline injection to the infrapatellar fat pad.

Primary Outcome Measures

Name	Time	Method
Infrared marker XYZ coordinates	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.	Baseline	Cuff-pressure algometry will be used to estimate pressure detection and tolerance thresholds, temporal summation of pain, and conditioned pain modulation.

Secondary Outcome Measures

Name	Time	Method
Ground reaction forces	Baseline	Ground reaction forces will be measured in Newton-meters with force plates embedded in the floor.
Ground reaction moments	Baseline	Ground reaction moments will be measured in Newton-meters with force plates embedded in the floor.
The Pittsburgh Sleep Quality Index score	Baseline	19 items summarized to a single score ranging from zero to 21 with higher scores reflecting worse quality of sleep.
The Pain catastrophizing Scale score	Baseline	13 items summarized to a single score ranging from zero to 52 with higher scores reflecting more catastrophizing.
The Hospital Anxiety and Depression Scale	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.
Knee symptoms	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.
Muscle activation	Baseline	Muscle activation will be measured in micro-volts using wireless EMG on the muscles of the lower extremities.
Ground contact XZ location	Baseline	Ground contact XZ coordinate location will be measured in milimeters with force plates embedded in the floor.

Trial Locations

Locations (1)

Aalborg University; 🇩🇰 Aalborg, Nordjylland, Denmark