Exploration of Gait Biomechanics and Muscle Pain of the Lower Extremity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypertonic saline injection, Isotonic saline injection.
- Who it may be relevant to
- Registry conditions: Pain, Acute. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Other Hypertonic saline injection
Injection with hypertonic saline (7%) - Other Isotonic saline injection
Injection with isotonic saline (0.9%)
Primary outcome measures
- Infrared marker XYZ coordinates [Time frame: Baseline.]
- Pain intensity (NRS 0-10) [Time frame: Baseline.]
Secondary outcome measures (5)
- Pain sensitivity. [Time frame: Baseline.]
- Ground reaction forces [Time frame: Baseline.]
- Ground reaction moments [Time frame: Baseline.]
- Ground contact XZ location [Time frame: Baseline.]
- Muscle activation [Time frame: Baseline.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Denmark · 1 center
- Aalborg University — Aalborg
Identifiers
NCT: NCT06411197 · N-20220063-2