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

Primary Purpose

Pain Response, Hyperalgesia, Healthy Subjects

Status
Unknown status
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
NGF
Isotonic-saline
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain Response focused on measuring NGF-induced hyperalgesia, Exercise-induced ischemic pain, Pain modulation, NGF pain model

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aalborg UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

NGF condition + Control condition

Control condition + NGF condition

Arm Description

All participants will receive 3 single injection of NGF (1ug/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle. After 4 weeks: All participants will receive 3 single injection of isotonic-saline (9%/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle.

All participants will receive 3 single injection of isotonic-saline (9%/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle. After 4 weeks: All participants will receive 3 single injection of NGF (1ug/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
Conditioning pain modulation (CPM) efficacy
A test stimuli will be applied and compared with a test stimuli simultaneous a condition stimuli.
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)

Full Information

First Posted
February 14, 2019
Last Updated
February 15, 2019
Sponsor
Aalborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03844243
Brief Title
Exercise-induced Ischemia and the Influence of Pain Modulation in a Nerve Growth Factor (NGF) Model
Official Title
Interaction Between NGF and Exercise-induced Ischemia, and the Influence of the Pain Modulating System in a Prolonged NGF Sensitized Muscle.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 18, 2019 (Anticipated)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Response, Hyperalgesia, Healthy Subjects
Keywords
NGF-induced hyperalgesia, Exercise-induced ischemic pain, Pain modulation, NGF pain model

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NGF condition + Control condition
Arm Type
Experimental
Arm Description
All participants will receive 3 single injection of NGF (1ug/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle. After 4 weeks: All participants will receive 3 single injection of isotonic-saline (9%/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle.
Arm Title
Control condition + NGF condition
Arm Type
Experimental
Arm Description
All participants will receive 3 single injection of isotonic-saline (9%/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle. After 4 weeks: All participants will receive 3 single injection of NGF (1ug/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle.
Intervention Type
Drug
Intervention Name(s)
NGF
Other Intervention Name(s)
Beta-Nerve Growth Factor, Human
Intervention Description
Intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Isotonic-saline
Other Intervention Name(s)
Control
Intervention Description
Intramuscular injection
Primary Outcome Measure Information:
Title
Muscle pain sensitivity (PPTs values) assessed by pressure algometer
Description
Pressure pain thresholds (PPTs) are assessed over the dominant tibialis anterior muscle using a handhold pressure algometer.
Time Frame
Change from baseline at 3 week
Secondary Outcome Measure Information:
Title
Ischemic-induced pain intensity
Description
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).
Time Frame
Assessed right after the exercise has been performed, change from baseline at 3 weeks
Title
Functional muscle pain
Description
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).
Time Frame
Change from baseline at 3 weeks
Title
Conditioning pain modulation (CPM) efficacy
Description
A test stimuli will be applied and compared with a test stimuli simultaneous a condition stimuli.
Time Frame
Change from baseline at 3 weeks
Title
Temporal summation of pain
Description
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)
Time Frame
Change from baseline at 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Line Bay Sørensen, PhD. stud.
Phone
52373229
Email
lbs@hst.aau.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Line Bay Sørensen, PhD. stud.
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University
City
Aalborg
ZIP/Postal Code
9220
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Line Bay Sørensen, Ph.d stud.
Phone
99404874
Email
lbs@hst.aau.dk

12. IPD Sharing Statement

Plan to Share IPD
No

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

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