Exploration of Gait Biomechanics and Pain

Healthy Clinical Trial

Official title:

Undersøgelse af sammenhængen Mellem Biomekanik og Smerter Ved Gang

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06330402
• Other study ID #: N-20220063
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Aalborg University
• Contact: Kristian K Petersen, Dr. Med
• Phone: (+45) 31697510
• Email: kkp[@]hst.aau.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Pain

Intervention

Other:
• Hypertonic saline injection
0.25 mL injection with hypertonic saline (7%) to the infrapatellar fat pad.
• Isotonic saline injection
Control injection with 0.25 mL isotonic saline (0.9%) to the infrapatellar fat pad.

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg	Nordjylland

Sponsors (1)

Lead Sponsor	Collaborator
Kristian Kjær Petersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Pain distribution	Pain during intervention is marked on a body chart	Baseline
Primary	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
Primary	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	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
Secondary	The Pain catastrophizing Scale score	13 items summarized to a single score ranging from zero to 52 with higher scores reflecting more catastrophizing.	Baseline
Secondary	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
Secondary	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
Secondary	Ground reaction forces	Ground reaction forces will be measured in Newton-meters with force plates embedded in the floor.	Baseline
Secondary	Ground reaction moments	Ground reaction moments will be measured in Newton-meters with force plates embedded in the floor.	Baseline
Secondary	Ground contact XZ location	Ground contact XZ coordinate location will be measured in milimeters with force plates embedded in the floor.	Baseline
Secondary	Muscle activation	Muscle activation will be measured in micro-volts using wireless EMG on the muscles of the lower extremities.	Baseline