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Interaction Between NGF and Acute Exercise-induced Ischemia

Early Phase 1
Completed
Conditions
Pain Response
Healthy Subjects
Hyperalgesia
Interventions
Drug: Isotonic saline
Registration Number
NCT03470038
Lead Sponsor
Aalborg University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
21
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Control condition + NGF conditionNGFAll 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
NGF condition + Control conditionIsotonic salineAll 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
Control condition + NGF conditionIsotonic salineAll 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
NGF condition + Control conditionNGFAll 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
Primary Outcome Measures
NameTimeMethod
Muscle sensitivityChange from baseline at 1 week

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

Secondary Outcome Measures
NameTimeMethod
Functional muscle painChange from baseline at 1 week

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

Muscle pain diaryChange 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

Ischemic-induced pain intensityAssessed 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)

Trial Locations

Locations (1)

Aalborg University

🇩🇰

Aalborg, Denmark

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