The Effect of Experimental Neck Pain in Healthy Participants

The Effect of Experimental Neck Pain in Healthy Participants - The Transition From Acute to Ongoing Pain

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

Study Overview

• Status: Unknown
• Conditions: Healthy; Neck Pain
• Intervention / Treatment: Other: Injection of Isotonic saline; Other: Injection of NGF

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)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9220
    • Recruiting
    • Dept. Of Health Science and Technology, SMI, Aalborg University
    • Contact: Steffan W Christensen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control group; Participants will be injected with 0.5ml Isotonic saline into a neck muscle	Other: Injection of Isotonic saline; 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).
Experimental: Neck pain; Participants will be injected with 0.5ml NGF into the a neck muscle	Other: Injection of NGF; Half the participants will be injected in a neck muscle with NGF (Neck pain group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pressure pain threshold (PPT) measured with a handheld pressure algometer	PPT will be assessed over head, neck, arm and leg sites.	Day 0, 2,4 and 15
Change in motor evoked potentials	Trans cranial magnetic stimulation (TMS) is used to asses motor evoked potentials of neck muscles	Day 0, 4 and 15
Change in Body movement	3D recordings of body movements	Day 0, 4 and 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in muscle activity (EMG)	EMG of axioscapular muscles & trunk during arm movements	Day 0, 4 and 15
Change in standing balance	Standing balance is measured on a force platform	Day 0, 4 and 15
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.	Day 0, 2,4 and 15
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)	Day 0, 2,4 and 15
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.	Day 2
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.	Day 2

Collaborators and Investigators

• Sponsor: Aalborg University

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2019
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: February 16, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: N-20180063_Sub-project_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No