Exploration of Gait Biomechanics and Muscle Pain of the Lower Extremity

Kristian Kjær Petersen

Status: Enrolling

Conditions: Pain, Acute

Treatments: Other: Hypertonic saline injection; Other: Isotonic saline injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06411197

N-20220063-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 6 patient groups

Gastrocnemius (painful condition)

Experimental group

Description:

1.5 mL injection of hypertonic saline (7%) to the gastrocnemius muscle.

Treatment:

Other: Hypertonic saline injection

Gastrocnemius (control condition)

Sham Comparator group

Description:

1.5 mL injection of isotonic saline (0.9%) to the gastrocnemius muscle.

Treatment:

Other: Isotonic saline injection

Biceps femoris (painful condition)

Experimental group

Description:

1.2 mL injection of hypertonic saline (7%) to the biceps femoris muscle.

Treatment:

Other: Hypertonic saline injection

Biceps femoris (control condition)

Sham Comparator group

Description:

1.2 mL injection of isotonic saline (0.9%) to the biceps femoris muscle.

Treatment:

Other: Isotonic saline injection

Semitendinosus (painful condition)

Experimental group

Description:

1.2 mL injection of hypertonic saline (7%) to the semitendinosus muscle.

Treatment:

Other: Hypertonic saline injection

Semitendinosus (control condition)

Sham Comparator group

Description:

1.2 mL injection of isotonic saline (7%) to the semitendinosus muscle.

Treatment:

Other: Isotonic saline injection