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Completed

NCT Number: NCT03470038

Interaction Between NGF and Acute Exercise-induced Ischemia

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.

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Key information

Conditions

Hyperalgesia Healthy Subjects Nervous System Diseases Neurologic Manifestations Pain Response Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Aalborg University

Aalborg, 9220, Denmark

About this study

Assessing evoked pain responses and muscle hyperalgesia following contractions during acute ischemia in a NGF-sensitized muscle may clarify whether an interaction between NGF sensitization and acidic stimulation exist.

It is hypothesized that acute ischemic exercise with the NGF-sensitized TA muscle, in contrast to ischemic exercise in a non-sensitized would: 1) potentiate pain-evoked responses, and 2) facilitate NGF-induced muscle hyperalgesia.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NGF

Drug

Intramuscular injection

Other names: Beta-Nerve Growth Factor, Human

Isotonic saline

Drug

Intramuscular injection

Other names: Control

Primary outcomes

  1. Muscle sensitivity

    Time frame: Change from baseline at 1 week

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

Secondary outcomes

  1. Ischemic-induced pain intensity

    Time frame: Assessed right after the dorsiflexions have been performed

    Subjects perform 45 dorsiflexions with their non-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 numeric rating scale (NRS)

  2. Functional muscle pain

    Time frame: Change from baseline at 1 week

    Subjects evaluate their muscle pain during movement using a Likert Scale for lower limp

  3. Muscle pain diary

    Time frame: Change from baseline at 1 week

    Subjects evaluate their muscle pain during movement using a Likert Scale for lower limp and perceived pain intensity at rest on a numeric rating scale (NRS). The diary is filled out at home on days between sessions

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

The Interaction Between NGF-induced Muscle Sensitivity and Acute Exercise-induced Ischemia

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2018
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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