NCT06411197

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Nov 2023Dec 2026

Study Start

First participant enrolled

November 8, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

May 8, 2024

Last Update Submit

September 30, 2025

Conditions

Pain, Acute

Keywords

Musculoskeletal painHealthy ParticipantsBiomechanics

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (5)

  • Pain sensitivity.

    Baseline.

  • Ground reaction forces

    Baseline.

  • Ground reaction moments

    Baseline.

  • Ground contact XZ location

    Baseline.

  • Muscle activation

    Baseline.

Other Outcomes (1)

  • Pain during jumping

    Baseline

Study Arms (6)

Gastrocnemius (painful condition)

EXPERIMENTAL

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

Other: Hypertonic saline injection

Gastrocnemius (control condition)

SHAM COMPARATOR

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

Other: Isotonic saline injection

Biceps femoris (painful condition)

EXPERIMENTAL

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

Other: Hypertonic saline injection

Biceps femoris (control condition)

SHAM COMPARATOR

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

Other: Isotonic saline injection

Semitendinosus (painful condition)

EXPERIMENTAL

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

Other: Hypertonic saline injection

Semitendinosus (control condition)

SHAM COMPARATOR

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

Other: Isotonic saline injection

Interventions

Hypertonic saline injectionOTHER

Injection with hypertonic saline (7%)

Biceps femoris (painful condition)Gastrocnemius (painful condition)Semitendinosus (painful condition)
Isotonic saline injectionOTHER

Injection with isotonic saline (0.9%)

Biceps femoris (control condition)Gastrocnemius (control condition)Semitendinosus (control condition)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women aged 18-45 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University

Aalborg, North Denmark, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Acute PainMusculoskeletal Pain

Interventions

Saline Solution, HypertonicSodium Chloride

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Kristian KS Petersen

    Aalborg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristian KS Petersen

CONTACT

31697510kkp@hst.aau.dk

Emma Hertel

CONTACT

60887473eh@hst.aau.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 13, 2024

Study Start

November 8, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Locations

DK(1)