Exploration of Gait Biomechanics and Muscle Pain of the Lower Extremity

Pain, Acute Clinical Trial

Official title:

Exploration of Gait Biomechanics and Muscle Pain of the Lower Extremity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06411197
• Other study ID #: N-20220063-2
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Aalborg University
• Contact: Kristian KS Petersen
• Phone: 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 muscle pain in the lower extremities. The study aims to:

A) Examine how experimental muscle pain in different types of muscles (ankle plantar-flexion, knee extension, and flexion muscles) affects kinematics, kinetics, and muscle activation

Participants will receive six muscle injections: a) Hypertonic saline (painful condition) and b) Isotonic saline (control condition) in 1) m. gastrocnemius, 2) m. semitendinosus, and 3) m. biceps femoris.

Description:

The proposed study will be a randomized, crossover design in which experimental pain will be induced in healthy subjects using hypertonic saline injections to three muscles of the lower extremities: The gastrocnemius muscle, the vastus medialis muscle, and the semitendinosus muscle. Participants will be block-randomized to receive an injection in each of the three muscles and will receive either the painful or control condition first for each muscle. The participant will always be blinded to the type of injection received.

Following the injection, there will typically be a 15-minute window of pain (45). Within this timeframe, motion capture will be carried out for both the control and painful conditions. During motion capture, the participants will perform multiple walking trials of approximately 10 meters. The participants will be equipped with electromyography (EMG) sensors on key muscles of the lower extremities. The participants will be asked for NRS ratings every 30 seconds throughout the 15 minutes with expected pain. There will be a 15-minute washout between the muscle injections.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• 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

• Myalgia
• Pain, Acute

Intervention

Other:
• Hypertonic saline injection
Injection with hypertonic saline (7%)
• Isotonic saline injection
Injection with isotonic saline (0.9%)

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 during jumping	Pain during jumping is captured on a numeric rating scale from 0 'no pain' to 10 'the worst pain imaginable'	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 millimeters. Reflective markers will be placed from head-to-toe on anatomical landmarks.	Baseline.
Primary	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 imaginable'	Baseline.
Secondary	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	Ground reaction forces	Ground reaction forces will be measured in Newtons 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 millimeters 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.