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

Sponsor

Aalborg University (Other)

Overall Status

Completed

CT.gov ID

NCT03217942

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperalgesia Healthy Subjects	Drug: NGF	Early Phase 1

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Double blind

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

Oct 1, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low dose All participants will receive 5 i.m injections of NGF (1 ug/0.5ml) into the tibialis anterior muscle (either left or right leg)	Drug: NGF Intramuscular injection Other Names: Beta-Nerve Growth Factor, Human
Experimental: High dose All participants will receive 1 high dose i.m bolus injection of NGF (5 ug/0.5ml) and 4 injections of saline (control/same volume) into the tibialis anterior muscle (either left or right leg)	Drug: NGF Intramuscular injection Other Names: Beta-Nerve Growth Factor, Human

Arm

Intervention/Treatment

Experimental: Low dose

All participants will receive 5 i.m injections of NGF (1 ug/0.5ml) into the tibialis anterior muscle (either left or right leg)

Drug: NGF

Intramuscular injection

Other Names:

Beta-Nerve Growth Factor, Human

Experimental: High dose

All participants will receive 1 high dose i.m bolus injection of NGF (5 ug/0.5ml) and 4 injections of saline (control/same volume) into the tibialis anterior muscle (either left or right leg)

Drug: NGF

Intramuscular injection

Other Names:

Beta-Nerve Growth Factor, Human

Outcome Measures

Primary Outcome Measures

Muscle sensitivity [Change from baseline at 3 weeks]
Pressure pain thresholds (PPTs) are assessed over the tibialis anterior muscles using a handhold pressure algometer.

Secondary Outcome Measures

Pressure-induced referred pain [Change from baseline at 3 weeks]
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.
Activity-induced muscle soreness [Change from baseline at 3 weeks]
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).
Pain intensity [Assessed continuously at 0-5 min during the injections at each leg]
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.
Muscle soreness Diary [Change from baseline at 3 weeks]
Two times a day subjects evaluate their muscle soreness using a Likert Scale of muscle soreness for lower limp
Activity-induced muscle soreness Diary [Change from baseline at 1 week]
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). The activity is performed at home on days in between the 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