Interaction Between NGF and Acute Exercise-induced Ischemia

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470038
• Other study ID #: N-2017-0007_S2
• Status: Completed
• Phase: Early Phase 1
• Start date: March 15, 2018
• Est. completion date: June 15, 2018

Study information

• Verified date: February 2019
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 15, 2018
• Est. primary completion date: May 15, 2018
• 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
• Ischemia
• Pain Response

Intervention

Drug:
• NGF
Intramuscular injection
• Isotonic saline
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 non-dominant tibialis anterior muscle using a handhold pressure algometer.	Change from baseline at 1 week
Secondary	Ischemic-induced pain intensity	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)	Assessed right after the dorsiflexions have been performed
Secondary	Functional muscle pain	Subjects evaluate their muscle pain during movement using a Likert Scale for lower limp	Change from baseline at 1 week
Secondary	Muscle pain diary	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	Change from baseline at 1 week