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Interaction Between NGF and Acute Exercise-induced Ischemia

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03470038
Enrollment
21
Registered
2018-03-19
Start date
2018-03-15
Completion date
2018-06-15
Last updated
2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects, Hyperalgesia, Pain Response

Keywords

NGF-induced pain, Ischemia-induced pain, Hyperalgesia, NGF pain model

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.

Detailed description

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.

Interventions

DRUGNGF

Intramuscular injection

DRUGIsotonic saline

Intramuscular injection

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Muscle sensitivityChange from baseline at 1 weekPressure pain thresholds (PPTs) are assessed over the non-dominant tibialis anterior muscle using a handhold pressure algometer.

Secondary

MeasureTime frameDescription
Ischemic-induced pain intensityAssessed right after the dorsiflexions have been performedSubjects 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)
Functional muscle painChange from baseline at 1 weekSubjects evaluate their muscle pain during movement using a Likert Scale for lower limp
Muscle pain diaryChange from baseline at 1 weekSubjects 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026