Exploration of Gait Biomechanics and Pain

Undersøgelse af sammenhængen Mellem Biomekanik og Smerter Ved Gang

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).

Study Overview

• Status: Recruiting
• Conditions: Pain; Healthy
• Intervention / Treatment: Other: Hypertonic saline injection; Other: Isotonic saline injection

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 Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristian K Petersen, Dr. Med; Phone Number: (+45) 31697510; Email: kkp@hst.aau.dk
• Study Contact Backup: Name: Emma Hertel, M. Sc.; Phone Number: (+45) 60887473; Email: eh@hst.aau.dk

Study Locations

• Denmark
  • Nordjylland
    • Aalborg, Nordjylland, Denmark, 9000
      • Recruiting
      • Aalborg University
      • Contact: Kristian K Petersen, Dr. Med; Phone Number: (+45) 31697510; Email: kkp@hst.aau.dk
      • Contact: Emma Hertel, M. Sc.; Phone Number: (+45) 60887473; Email: eh@hst.aau.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Painful condition; Hypertonic saline injection to the infrapatellar fat pad.	Other: Hypertonic saline injection; 0.25 mL injection with hypertonic saline (7%) to the infrapatellar fat pad.
Placebo Comparator: Control condition; Isotonic saline injection to the infrapatellar fat pad.	Other: Isotonic saline injection; Control injection with 0.25 mL isotonic saline (0.9%) to the infrapatellar fat pad.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 imagineable'	Baseline
Pain distribution	Pain during intervention is marked on a body chart	Baseline

Collaborators and Investigators

• Sponsor: Kristian Kjær Petersen

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: N-20220063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No