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The Effect of Experimental Neck Pain in Healthy Participants

Primary Purpose

Healthy, Neck Pain

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Injection of Isotonic saline
Injection of NGF
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy men and women aged 18-50 years
  • Only for sub-projects 1 and 2: Right-handed
  • Able to speak, read and understand Danish and English

Exclusion Criteria:

  • Pain from the neck or shoulder area during the past 6 months
  • Experience of delayed onset muscle soreness (DOMS) during the week leading up to the test session
  • Former surgery in neck or shoulder
  • Current or previous chronic or recurrent pain condition
  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous neurologic, musculoskeletal or mental illnesses
  • Regular use of analgesics
  • Abnormally disrupted sleep in the last 24 hours preceding the experiment
  • Lack of ability to cooperate
  • Unable to pass the TASS safety screening questionnaire for TMS

Sites / Locations

  • Dept. Of Health Science and Technology, SMI, Aalborg UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control group

Neck pain

Arm Description

Participants will be injected with 0.5ml Isotonic saline into a neck muscle

Participants will be injected with 0.5ml NGF into the a neck muscle

Outcomes

Primary Outcome Measures

Change in pressure pain threshold (PPT) measured with a handheld pressure algometer
PPT will be assessed over head, neck, arm and leg sites.
Change in motor evoked potentials
Trans cranial magnetic stimulation (TMS) is used to asses motor evoked potentials of neck muscles
Change in Body movement
3D recordings of body movements

Secondary Outcome Measures

Change in muscle activity (EMG)
EMG of axioscapular muscles & trunk during arm movements
Change in standing balance
Standing balance is measured on a force platform
Change in perceived pain: McGill Pain Questionnaire
Pain will be scored using a scale from 0-10 with 0 being no pain and 10 being worst imaginable pain, by drawing on body charts and choosing words from the McGill Pain Questionnaire.
Disability
Neck disability Index will be scored. Body movements will be scored on a modified 6-point Likert scale (0 = not difficult at all; 1 = minimally difficult; 2 = somewhat difficult; 3 = fairly difficult; 4 = very difficult; 5 = unable to perform)
Pain Catastrophizing Scale (13 item questionnaire)
Pain Catastrophizing Scale (PCS) questionnaire. 13 items that can be answered with a Likert scale (0 = not at all, 1 = to a slight degree, 2= to a moderate degree, 3 = to a great degree, 4 = all the time). The PCS is scored by summing responses to all 13 items with scores ranging from 0 - 52.
The Big Five Inventory (BFI)
BFI questionnaire investigates five general traits personality: extraversion, agreeableness, conscientiousness, neuroticism and openness. The BFI consists of 44 items that are answered on a 5 point Likert scale (1=Disagree strongly, 2=Disagree a little, 3=Neither agree or disagree, 4=Agree a little, 5=Agree strongly). This is not good/bad score in this questionnaire as it only assess personality traits.

Full Information

First Posted
February 16, 2019
Last Updated
February 19, 2019
Sponsor
Aalborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03848247
Brief Title
The Effect of Experimental Neck Pain in Healthy Participants
Official Title
The Effect of Experimental Neck Pain in Healthy Participants - The Transition From Acute to Ongoing Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2019 (Actual)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
May 1, 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

5. Study Description

Brief Summary
This study investigates if/how an experimentally applied muscle pain/soreness, lasting for some days may affect brain activity, balance, movement patterns, muscle function and pain sensitivity in a healthy population
Detailed Description
All included healthy volunteers will participate in test-sessions on 4 separate days over approximately 2 weeks. During the study participants will be randomised into and either a control group (injection of isotonic saline into a neck muscle) or neck pain group (injection of Nerve Growth Factor (NGF) into a neck muscle). Alle participants tested with regards to: Brain activity related to neck muscles will be estimated using TMS Balance will be tested using a force place Body movements will be recorded using 3D tracking Muscle activity will be estimated using electromyography (EMG)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Neck Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Experimental
Arm Description
Participants will be injected with 0.5ml Isotonic saline into a neck muscle
Arm Title
Neck pain
Arm Type
Experimental
Arm Description
Participants will be injected with 0.5ml NGF into the a neck muscle
Intervention Type
Other
Intervention Name(s)
Injection of Isotonic saline
Intervention Description
Half the participants will be injected in a neck muscle with isotonic saline (Control group) and the other half will get NGF (Neck pain group).
Intervention Type
Other
Intervention Name(s)
Injection of NGF
Intervention Description
Half the participants will be injected in a neck muscle with NGF (Neck pain group).
Primary Outcome Measure Information:
Title
Change in pressure pain threshold (PPT) measured with a handheld pressure algometer
Description
PPT will be assessed over head, neck, arm and leg sites.
Time Frame
Day 0, 2,4 and 15
Title
Change in motor evoked potentials
Description
Trans cranial magnetic stimulation (TMS) is used to asses motor evoked potentials of neck muscles
Time Frame
Day 0, 4 and 15
Title
Change in Body movement
Description
3D recordings of body movements
Time Frame
Day 0, 4 and 15
Secondary Outcome Measure Information:
Title
Change in muscle activity (EMG)
Description
EMG of axioscapular muscles & trunk during arm movements
Time Frame
Day 0, 4 and 15
Title
Change in standing balance
Description
Standing balance is measured on a force platform
Time Frame
Day 0, 4 and 15
Title
Change in perceived pain: McGill Pain Questionnaire
Description
Pain will be scored using a scale from 0-10 with 0 being no pain and 10 being worst imaginable pain, by drawing on body charts and choosing words from the McGill Pain Questionnaire.
Time Frame
Day 0, 2,4 and 15
Title
Disability
Description
Neck disability Index will be scored. Body movements will be scored on a modified 6-point Likert scale (0 = not difficult at all; 1 = minimally difficult; 2 = somewhat difficult; 3 = fairly difficult; 4 = very difficult; 5 = unable to perform)
Time Frame
Day 0, 2,4 and 15
Title
Pain Catastrophizing Scale (13 item questionnaire)
Description
Pain Catastrophizing Scale (PCS) questionnaire. 13 items that can be answered with a Likert scale (0 = not at all, 1 = to a slight degree, 2= to a moderate degree, 3 = to a great degree, 4 = all the time). The PCS is scored by summing responses to all 13 items with scores ranging from 0 - 52.
Time Frame
Day 2
Title
The Big Five Inventory (BFI)
Description
BFI questionnaire investigates five general traits personality: extraversion, agreeableness, conscientiousness, neuroticism and openness. The BFI consists of 44 items that are answered on a 5 point Likert scale (1=Disagree strongly, 2=Disagree a little, 3=Neither agree or disagree, 4=Agree a little, 5=Agree strongly). This is not good/bad score in this questionnaire as it only assess personality traits.
Time Frame
Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy men and women aged 18-50 years Only for sub-projects 1 and 2: Right-handed Able to speak, read and understand Danish and English Exclusion Criteria: Pain from the neck or shoulder area during the past 6 months Experience of delayed onset muscle soreness (DOMS) during the week leading up to the test session Former surgery in neck or shoulder Current or previous chronic or recurrent pain condition Pregnancy Drug addiction defined as the use of cannabis, opioids or other drugs Previous neurologic, musculoskeletal or mental illnesses Regular use of analgesics Abnormally disrupted sleep in the last 24 hours preceding the experiment Lack of ability to cooperate Unable to pass the TASS safety screening questionnaire for TMS
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steffan W Christensen, PhD
Phone
+45 99408889
Email
stc@hst.aau.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffan W Christensen, PhD
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. Of Health Science and Technology, SMI, Aalborg University
City
Aalborg
ZIP/Postal Code
9220
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steffan W Christensen, PhD

12. IPD Sharing Statement

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The Effect of Experimental Neck Pain in Healthy Participants

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