NCT03844243

Brief Summary

The purpose of this study is to investigate responses of pain and the maintenance of mechanical muscle hypersensitivity following an acute exercise-induced ischemic condition repeated over time in a prolonged NGF-sensitized muscle. Additionally, the influence of the pain modulating system on prolonged NGF muscle hypersensitivity caused by peripheral mechanisms and central mechanisms will also be investigated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Feb 2019

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

February 18, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

February 14, 2019

Last Update Submit

February 15, 2019

Conditions

Pain ResponseHyperalgesiaHealthy Subjects

Keywords

NGF-induced hyperalgesiaExercise-induced ischemic painPain modulationNGF pain model

Outcome Measures

Primary Outcomes (1)

  • Muscle pain sensitivity (PPTs values) assessed by pressure algometer

    Pressure pain thresholds (PPTs) are assessed over the dominant tibialis anterior muscle using a handhold pressure algometer.

    Change from baseline at 3 week

Secondary Outcomes (4)

  • Ischemic-induced pain intensity

    Assessed right after the exercise has been performed, change from baseline at 3 weeks

  • Functional muscle pain

    Change from baseline at 3 weeks

  • Conditioning pain modulation (CPM) efficacy

    Change from baseline at 3 weeks

  • Temporal summation of pain

    Change from baseline at 3 weeks

Study Arms (2)

NGF condition + Control condition

EXPERIMENTAL

All participants will receive 3 single injection of NGF (1ug/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle. After 4 weeks: All participants will receive 3 single injection of isotonic-saline (9%/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle.

Drug: NGFDrug: Isotonic-saline

Control condition + NGF condition

EXPERIMENTAL

All participants will receive 3 single injection of isotonic-saline (9%/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle. After 4 weeks: All participants will receive 3 single injection of NGF (1ug/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle.

Drug: NGFDrug: Isotonic-saline

Interventions

NGFDRUG

Intramuscular injection

Also known as: Beta-Nerve Growth Factor, Human
Control condition + NGF conditionNGF condition + Control condition
Isotonic-salineDRUG

Intramuscular injection

Also known as: Control
Control condition + NGF conditionNGF condition + Control condition

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy and pain free volunteers

You may not qualify if:

  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous neurologic, mental illnesses, or psychiatric diseases.
  • Past history of chronic pain in the musculoskeletal system (muscle, joint, cartilage, connective tissue)
  • Participation in other pain trials throughout the study period
  • Lack of ability to cooperate
  • Taking any analgesic 24 hours before the injections
  • Performing any strenuous leg exercise through out the study period causing sore muscles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University

Aalborg, 9220, Denmark

RECRUITING

MeSH Terms

Conditions

Hyperalgesia

Interventions

Nerve Growth FactorSodium Chloride

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nerve Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsNerve Tissue ProteinsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Line Bay Sørensen, PhD. stud.

    Aalborg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Line Bay Sørensen, PhD. stud.

CONTACT

52373229lbs@hst.aau.dk

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blinded
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD.stud.

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 18, 2019

Study Start

February 18, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

February 18, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)