Exercise-induced Ischemia and the Influence of Pain Modulation in a Nerve Growth Factor (NGF) Model

Healthy Subjects Clinical Trial

Official title:

Interaction Between NGF and Exercise-induced Ischemia, and the Influence of the Pain Modulating System in a Prolonged NGF Sensitized Muscle.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03844243
• Other study ID #: N-2017-0007_S3
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 18, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2019
• Source: Aalborg University
• Contact: Line Bay Sørensen, PhD. stud.
• Phone: 52373229
• Email: lbs[@]hst.aau.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate responses of pain and the maintenance of mechanical muscle hypersensitivity following an acute exercise-induced ischemic condition repeated over time in a prolonged NGF-sensitized muscle. Additionally, the influence of the pain modulating system on prolonged NGF muscle hypersensitivity caused by peripheral mechanisms and central mechanisms will also be investigated.

Description:

The hypothesis is that an ischemic conditioning in a NGF-sensitized muscle is able to facilitate pain responses and that over time the pain modulation system is responsible for a subsequent reduction in muscle sensitivity towards mechanical pressure and a decrease in pain intensity following a period of NGF-induced muscle hypersensitivity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• 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 pain sensitivity (PPTs values) assessed by pressure algometer	Pressure pain thresholds (PPTs) are assessed over the dominant tibialis anterior muscle using a handhold pressure algometer.	Change from baseline at 3 week
Secondary	Ischemic-induced pain intensity	Subjects perform a repeated static exercise with their 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 11-point numeric rating scale (NRS) rating from 0 (no pain) to 10 (worst pain imaginable).	Assessed right after the exercise has been performed, change from baseline at 3 weeks
Secondary	Functional muscle pain	Subjects evaluate their muscle pain during movement using a 7-point Likert Scale for lower limp rating from 0 (a complete absence of pain) to 6 (a severe pain that limits my ability to move).	Change from baseline at 3 weeks
Secondary	Conditioning pain modulation (CPM) efficacy	A test stimuli will be applied and compared with a test stimuli simultaneous a condition stimuli.	Change from baseline at 3 weeks
Secondary	Temporal summation of pain	10 repeated stimuli will be applied and subjects will be asked to rate the pain for each individual stimuli on a 11-point visual analogue scale (VAS) rating from 0 (no pain) to 10 (worst pain imaginable)	Change from baseline at 3 weeks