Interaction Between NGF and Acute Exercise-induced Ischemia

Sponsor

Aalborg University (Other)

Overall Status

Completed

CT.gov ID

NCT03470038

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperalgesia Pain Response Healthy Subjects	Drug: NGF Drug: Isotonic saline	Early Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Mar 15, 2018

Actual Primary Completion Date :

May 15, 2018

Actual Study Completion Date :

Jun 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NGF condition + Control condition All 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	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 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	Drug: NGF Intramuscular injection Other Names: Beta-Nerve Growth Factor, Human Drug: Isotonic saline Intramuscular injection Other Names: Control

Arm

Intervention/Treatment

Experimental: NGF condition + Control condition

All 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

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 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

Drug: NGF

Intramuscular injection

Other Names:

Beta-Nerve Growth Factor, Human

Drug: Isotonic saline

Intramuscular injection

Other Names:

Control

Outcome Measures

Primary Outcome Measures

Muscle sensitivity [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 Outcome Measures

Ischemic-induced pain intensity [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)
Functional muscle pain [Change from baseline at 1 week]
Subjects evaluate their muscle pain during movement using a Likert Scale for lower limp
Muscle pain diary [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

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