NCT03470038

Brief Summary

The purpose of this study is to investigate pain evoked responses and facilitation of NGF-induced mechanical muscle hyperalgesia over time following an acute exercised-induced ischemic condition in a NGF-sensitized muscle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Mar 2018

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

March 13, 2018

Last Update Submit

February 14, 2019

Conditions

HyperalgesiaPain ResponseHealthy Subjects

Keywords

NGF-induced painIschemia-induced painHyperalgesiaNGF pain model

Outcome Measures

Primary Outcomes (1)

  • Muscle sensitivity

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

    Change from baseline at 1 week

Secondary Outcomes (3)

  • Ischemic-induced pain intensity

    Assessed right after the dorsiflexions have been performed

  • Functional muscle pain

    Change from baseline at 1 week

  • Muscle pain diary

    Change from baseline at 1 week

Study Arms (2)

NGF condition + Control condition

EXPERIMENTAL

All participants will receive five injections with NGF (1ug/0.5ml) into the tibialis anterior muscle in their non-dominant leg After 4 weeks: All participants will receive five injections with isotonic saline (9%/0.5ml) into the tibialis anterior muscle in their non-dominant leg

Drug: NGFDrug: Isotonic saline

Control condition + NGF condition

EXPERIMENTAL

All participants will receive five injections with isotonic saline (9%/0.5ml) into the tibialis anterior muscle in their non-dominant leg After 4 weeks: All participants will receive five injections with NGF (1ug/0.5ml) into the tibialis anterior muscle in their non-dominant leg

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

Location

Related Publications (1)

  • Sorensen LB, Gazerani P, Graven-Nielsen T. Nerve growth factor-induced muscle hyperalgesia facilitates ischaemic contraction-evoked pain. Eur J Pain. 2019 Nov;23(10):1814-1825. doi: 10.1002/ejp.1455. Epub 2019 Aug 5.

    PMID: 31314952DERIVED

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, Ph.d stud.

    Aalborg University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 13, 2018

First Posted

March 19, 2018

Study Start

March 15, 2018

Primary Completion

May 15, 2018

Study Completion

June 15, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)