Exercise-induced Ischemia and the Influence of Pain Modulation in a Nerve Growth Factor (NGF) Model

Sponsor
Aalborg University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03844243
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

The hypothesis is that an ischemic conditioning in a NGF-sensitized muscle is able to facilitate pain responses and that over time the pain modulation system is responsible for a subsequent reduction in muscle sensitivity towards mechanical pressure and a decrease in pain intensity following a period of NGF-induced muscle hypersensitivity.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Double-blinded
Primary Purpose:
Basic Science
Official Title:
Interaction Between NGF and Exercise-induced Ischemia, and the Influence of the Pain Modulating System in a Prolonged NGF Sensitized Muscle.
Anticipated Study Start Date :
Feb 18, 2019
Anticipated Primary Completion Date :
Jun 30, 2019
Anticipated Study Completion Date :
Jun 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: NGF condition + Control condition

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: NGF
Intramuscular injection
Other Names:
  • Beta-Nerve Growth Factor, Human
  • Drug: Isotonic-saline
    Intramuscular injection
    Other Names:
  • Control
  • Experimental: Control condition + NGF condition

    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: NGF
    Intramuscular injection
    Other Names:
  • Beta-Nerve Growth Factor, Human
  • Drug: Isotonic-saline
    Intramuscular injection
    Other Names:
  • Control
  • Outcome Measures

    Primary Outcome Measures

    1. Muscle pain sensitivity (PPTs values) assessed by pressure algometer [Change from baseline at 3 week]

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

    Secondary Outcome Measures

    1. Ischemic-induced pain intensity [Assessed right after the exercise has been performed, change from baseline at 3 weeks]

      Subjects perform a repeated static exercise with their dominant leg while a cuff is mounted over the knee to occlude the blodflow from the muscle (ischemia). Subjects subsequently rate their perceived pain intensity verbally on a 11-point numeric rating scale (NRS) rating from 0 (no pain) to 10 (worst pain imaginable).

    2. Functional muscle pain [Change from baseline at 3 weeks]

      Subjects evaluate their muscle pain during movement using a 7-point Likert Scale for lower limp rating from 0 (a complete absence of pain) to 6 (a severe pain that limits my ability to move).

    3. Conditioning pain modulation (CPM) efficacy [Change from baseline at 3 weeks]

      A test stimuli will be applied and compared with a test stimuli simultaneous a condition stimuli.

    4. Temporal summation of pain [Change from baseline at 3 weeks]

      10 repeated stimuli will be applied and subjects will be asked to rate the pain for each individual stimuli on a 11-point visual analogue scale (VAS) rating from 0 (no pain) to 10 (worst pain imaginable)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy and pain free volunteers
    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aalborg University Aalborg Denmark 9220

    Sponsors and Collaborators

    • Aalborg University

    Investigators

    • Principal Investigator: Line Bay Sørensen, PhD. stud., Aalborg University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Line Bay Sørensen, PhD.stud., Aalborg University
    ClinicalTrials.gov Identifier:
    NCT03844243
    Other Study ID Numbers:
    • N-2017-0007_S3
    First Posted:
    Feb 18, 2019
    Last Update Posted:
    Feb 18, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Line Bay Sørensen, PhD.stud., Aalborg University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 18, 2019