Exploration of Gait Biomechanics and Muscle Pain of the Lower Extremity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-08

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Gastrocnemius (painful condition)

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

Group Type EXPERIMENTAL

Hypertonic saline injection

Intervention Type OTHER

Injection with hypertonic saline (7%)

Gastrocnemius (control condition)

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

Group Type SHAM_COMPARATOR

Isotonic saline injection

Intervention Type OTHER

Injection with isotonic saline (0.9%)

Biceps femoris (painful condition)

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

Group Type EXPERIMENTAL

Hypertonic saline injection

Intervention Type OTHER

Injection with hypertonic saline (7%)

Biceps femoris (control condition)

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

Group Type SHAM_COMPARATOR

Isotonic saline injection

Intervention Type OTHER

Injection with isotonic saline (0.9%)

Semitendinosus (painful condition)

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

Group Type EXPERIMENTAL

Hypertonic saline injection

Intervention Type OTHER

Injection with hypertonic saline (7%)

Semitendinosus (control condition)

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

Group Type SHAM_COMPARATOR

Isotonic saline injection

Intervention Type OTHER

Injection with isotonic saline (0.9%)

Interventions

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Hypertonic saline injection

Injection with hypertonic saline (7%)

Intervention Type OTHER

Isotonic saline injection

Injection with isotonic saline (0.9%)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes