Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model

Early Phase 1CompletedNCT03217942

Aalborg University20 enrolled

Overview

The purpose of this study is to investigate and determine the time course and distribution on muscle hyperalgesia and muscle pain in a repeated, low dose NGF model. It is hypothesized that low dosages i.m injections of NGF are able to induce mechanical hyperalgesia and muscle soreness in a same manner (effect of duration) as for dosages previously used in NGF studies. Furthermore, it is also speculated if several injections of low dose NGF into the muscle combined are able to course immediate pain sensation and spreading of muscle hypersensitivity.

Effects of pain responses, symptom development and pattern (time course and distribution) following 5 i.m low dose injections of NGF injected into the tibialis anterior muscle will be compared to a high dose i.m injection of NGF injected into the contralateral side in healthy pain-free subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Hyperalgesia Healthy Subjects

Interventions

NGFDRUG

Intramuscular injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Aalborg University

Aalborg, Denmark

Outcomes

Primary Outcomes

Muscle sensitivity

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

Time frame: Change from baseline at 3 weeks

Secondary Outcomes

Pressure-induced referred pain

At three predetermined sites within the tibialis anterior muscle, a constant pressure stimulation (120% of PPT) is evoked by use of the pressure algometer. Subjects color their perceived sensation of pain on an electronic schematic of the lower legs using Navigate Pain.

Time frame: Change from baseline at 3 weeks

Activity-induced muscle soreness

Subjects perform 10 dorsiflexions with each leg. The perceived muscle soreness is reported using a numeric rating scale (NRS) and the area of soreness is colored on an electronic schematic of the lower legs (Navigate Pain).

Time frame: Change from baseline at 3 weeks

Pain intensity

Subjects rate their perceived pain intensity on a visual analogue scale (VAS) App (Aalborg University) as displayed on a tablet computer with a sample rate of 1 Hz.

Time frame: Assessed continuously at 0-5 min during the injections at each leg

Muscle soreness Diary

Two times a day subjects evaluate their muscle soreness using a Likert Scale of muscle soreness for lower limp

Time frame: Change from baseline at 3 weeks

Activity-induced muscle soreness Diary

Data from ClinicalTrials.gov

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