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

Primary Purpose

Hyperalgesia, Healthy Subjects

Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
NGF
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 Muscle soreness, NGF-induced pain, Pain model, Long-lasting sensitization

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

Low dose

High dose

Arm Description

All participants will receive 5 i.m injections of NGF (1 ug/0.5ml) into the tibialis anterior muscle (either left or right leg)

All participants will receive 1 high dose i.m bolus injection of NGF (5 ug/0.5ml) and 4 injections of saline (control/same volume) into the tibialis anterior muscle (either left or right leg)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).
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.
Muscle soreness Diary
Two times a day subjects evaluate their muscle soreness using a Likert Scale of muscle soreness for lower limp
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

Full Information

First Posted
July 10, 2017
Last Updated
January 10, 2018
Sponsor
Aalborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03217942
Brief Title
Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model
Official Title
Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
October 1, 2017 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperalgesia, Healthy Subjects
Keywords
Muscle soreness, NGF-induced pain, Pain model, Long-lasting sensitization

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Masking Description
Double blind
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose
Arm Type
Experimental
Arm Description
All participants will receive 5 i.m injections of NGF (1 ug/0.5ml) into the tibialis anterior muscle (either left or right leg)
Arm Title
High dose
Arm Type
Experimental
Arm Description
All participants will receive 1 high dose i.m bolus injection of NGF (5 ug/0.5ml) and 4 injections of saline (control/same volume) into the tibialis anterior muscle (either left or right leg)
Intervention Type
Drug
Intervention Name(s)
NGF
Other Intervention Name(s)
Beta-Nerve Growth Factor, Human
Intervention Description
Intramuscular injection
Primary Outcome Measure Information:
Title
Muscle sensitivity
Description
Pressure pain thresholds (PPTs) are assessed over the tibialis anterior muscles using a handhold pressure algometer.
Time Frame
Change from baseline at 3 weeks
Secondary Outcome Measure Information:
Title
Pressure-induced referred pain
Description
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.
Time Frame
Change from baseline at 3 weeks
Title
Activity-induced muscle soreness
Description
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).
Time Frame
Change from baseline at 3 weeks
Title
Pain intensity
Description
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.
Time Frame
Assessed continuously at 0-5 min during the injections at each leg
Title
Muscle soreness Diary
Description
Two times a day subjects evaluate their muscle soreness using a Likert Scale of muscle soreness for lower limp
Time Frame
Change from baseline at 3 weeks
Title
Activity-induced muscle soreness Diary
Description
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
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

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

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