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Interaction Between NGF and Acute Exercise-induced Ischemia

Primary Purpose

Hyperalgesia, Pain Response, Healthy Subjects

Status
Completed
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 Hyperalgesia focused on measuring NGF-induced pain, Ischemia-induced pain, Hyperalgesia, 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 University

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 five injections with NGF (1ug/0.5ml) into the tibialis anterior muscle in their non-dominant leg After 4 weeks: All participants will receive five injections with isotonic saline (9%/0.5ml) into the tibialis anterior muscle in their non-dominant leg

All participants will receive five injections with isotonic saline (9%/0.5ml) into the tibialis anterior muscle in their non-dominant leg After 4 weeks: All participants will receive five injections with NGF (1ug/0.5ml) into the tibialis anterior muscle in their non-dominant leg

Outcomes

Primary Outcome Measures

Muscle sensitivity
Pressure pain thresholds (PPTs) are assessed over the non-dominant tibialis anterior muscle using a handhold pressure algometer.

Secondary Outcome Measures

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)
Functional muscle pain
Subjects evaluate their muscle pain during movement using a Likert Scale for lower limp
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

Full Information

First Posted
March 13, 2018
Last Updated
February 14, 2019
Sponsor
Aalborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03470038
Brief Title
Interaction Between NGF and Acute Exercise-induced Ischemia
Official Title
The Interaction Between NGF-induced Muscle Sensitivity and Acute Exercise-induced Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)

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 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.
Detailed 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NGF condition + Control condition
Arm Type
Experimental
Arm Description
All participants will receive five injections with NGF (1ug/0.5ml) into the tibialis anterior muscle in their non-dominant leg After 4 weeks: All participants will receive five injections with isotonic saline (9%/0.5ml) into the tibialis anterior muscle in their non-dominant leg
Arm Title
Control condition + NGF condition
Arm Type
Experimental
Arm Description
All participants will receive five injections with isotonic saline (9%/0.5ml) into the tibialis anterior muscle in their non-dominant leg After 4 weeks: All participants will receive five injections with NGF (1ug/0.5ml) into the tibialis anterior muscle in their non-dominant leg
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 sensitivity
Description
Pressure pain thresholds (PPTs) are assessed over the non-dominant tibialis anterior muscle using a handhold pressure algometer.
Time Frame
Change from baseline at 1 week
Secondary Outcome Measure Information:
Title
Ischemic-induced pain intensity
Description
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)
Time Frame
Assessed right after the dorsiflexions have been performed
Title
Functional muscle pain
Description
Subjects evaluate their muscle pain during movement using a Likert Scale for lower limp
Time Frame
Change from baseline at 1 week
Title
Muscle pain diary
Description
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
Time Frame
Change from baseline at 1 week

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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Line Bay Sørensen, Ph.d stud.
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University
City
Aalborg
ZIP/Postal Code
9220
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31314952
Citation
Sorensen LB, Gazerani P, Graven-Nielsen T. Nerve growth factor-induced muscle hyperalgesia facilitates ischaemic contraction-evoked pain. Eur J Pain. 2019 Nov;23(10):1814-1825. doi: 10.1002/ejp.1455. Epub 2019 Aug 5. Erratum In: Eur J Pain. 2020 Feb;24(2):470-472.
Results Reference
derived

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Interaction Between NGF and Acute Exercise-induced Ischemia

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