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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03217942
• Other study ID #: N-2017-0007
• Status: Completed
• Phase: Early Phase 1
• First received: July 10, 2017
• Last updated: January 10, 2018
• Start date: July 1, 2017
• Est. completion date: October 1, 2017

Study information

• Verified date: January 2018
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects
• Hyperalgesia

Intervention

Drug:
• NGF
Intramuscular injection

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle sensitivity	Pressure pain thresholds (PPTs) are assessed over the tibialis anterior muscles using a handhold pressure algometer.	Change from baseline at 3 weeks
Secondary	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.	Change from baseline at 3 weeks
Secondary	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).	Change from baseline at 3 weeks
Secondary	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.	Assessed continuously at 0-5 min during the injections at each leg
Secondary	Muscle soreness Diary	Two times a day subjects evaluate their muscle soreness using a Likert Scale of muscle soreness for lower limp	Change from baseline at 3 weeks
Secondary	Activity-induced muscle soreness Diary	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	Change from baseline at 1 week