Exploration of Gait Biomechanics and Pain

NCT06330402 | Completed DMC

• 1 other identifier: N-20220063
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain; Healthy

Outcome Measures

Primary Outcomes (2)

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

  Baseline

• Pain sensitivity.

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

  Baseline

Secondary Outcomes (8)

• The Pittsburgh Sleep Quality Index score

  Baseline

• The Pain catastrophizing Scale score

  Baseline

• The Hospital Anxiety and Depression Scale

  Baseline

• Knee symptoms

  Baseline

• Ground reaction forces

  Baseline

Other Outcomes (2)

• Pain intensity (NRS 0-10)

  Baseline

• Pain distribution

  Baseline

Study Arms (2)

Painful condition

EXPERIMENTAL

Hypertonic saline injection to the infrapatellar fat pad.

Other: Hypertonic saline injection

Control condition

PLACEBO COMPARATOR

Isotonic saline injection to the infrapatellar fat pad.

Other: Isotonic saline injection

Interventions

Hypertonic saline injection OTHER

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

Painful condition

Isotonic saline injection OTHER

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

Control condition

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women aged 18-45 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Kristian Kjær Petersen: lead

Study Sites (1)

Aalborg University

Aalborg, North Denmark, 9000, Denmark

Location

MeSH Terms

Conditions

Pain

Interventions

Saline Solution, Hypertonic; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 26, 2024
• Study Start: September 26, 2023
• Primary Completion: February 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

DK (1)