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Clinical Trials/NCT03848247
NCT03848247
Unknown
Not Applicable

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

Aalborg University1 site in 1 country40 target enrollmentJanuary 21, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Aalborg University
Enrollment
40
Locations
1
Primary Endpoint
Change in pressure pain threshold (PPT) measured with a handheld pressure algometer
Last Updated
7 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
January 21, 2019
End Date
May 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aalborg University
Responsible Party
Principal Investigator
Principal Investigator

Steffan Wittrup Christensen

Assistant professor

Aalborg University

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

Outcomes

Primary Outcomes

Change in pressure pain threshold (PPT) measured with a handheld pressure algometer

Time Frame: Day 0, 2,4 and 15

PPT will be assessed over head, neck, arm and leg sites.

Change in motor evoked potentials

Time Frame: Day 0, 4 and 15

Trans cranial magnetic stimulation (TMS) is used to asses motor evoked potentials of neck muscles

Change in Body movement

Time Frame: Day 0, 4 and 15

3D recordings of body movements

Secondary Outcomes

  • The Big Five Inventory (BFI)(Day 2)
  • Change in standing balance(Day 0, 4 and 15)
  • Disability(Day 0, 2,4 and 15)
  • Pain Catastrophizing Scale (13 item questionnaire)(Day 2)
  • Change in muscle activity (EMG)(Day 0, 4 and 15)
  • Change in perceived pain: McGill Pain Questionnaire(Day 0, 2,4 and 15)

Study Sites (1)

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