Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Experimental Neck Pain in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03848247
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Steffan Wittrup Christensen, Aalborg University

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

Condition or disease Intervention/treatment Phase
Healthy Neck Pain Other: Injection of Isotonic saline Other: Injection of NGF Not Applicable

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)


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Experimental Neck Pain in Healthy Participants - The Transition From Acute to Ongoing Pain
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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.

  2. 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

  3. Change in Body movement [ Time Frame: Day 0, 4 and 15 ]
    3D recordings of body movements


Secondary Outcome Measures :
  1. Change in muscle activity (EMG) [ Time Frame: Day 0, 4 and 15 ]
    EMG of axioscapular muscles & trunk during arm movements

  2. Change in standing balance [ Time Frame: Day 0, 4 and 15 ]
    Standing balance is measured on a force platform

  3. Change in perceived pain: McGill Pain Questionnaire [ Time Frame: Day 0, 2,4 and 15 ]
    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.

  4. Disability [ Time Frame: Day 0, 2,4 and 15 ]
    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)

  5. Pain Catastrophizing Scale (13 item questionnaire) [ Time Frame: Day 2 ]

    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.


  6. The Big Five Inventory (BFI) [ Time Frame: Day 2 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848247


Contacts
Layout table for location contacts
Contact: Steffan W Christensen, PhD +45 99408889 stc@hst.aau.dk

Locations
Layout table for location information
Denmark
Dept. Of Health Science and Technology, SMI, Aalborg University Recruiting
Aalborg, Denmark, 9220
Contact: Steffan W Christensen, PhD         
Sponsors and Collaborators
Aalborg University
Investigators
Layout table for investigator information
Principal Investigator: Steffan W Christensen, PhD Aalborg University

Layout table for additonal information
Responsible Party: Steffan Wittrup Christensen, Assistant professor, Aalborg University
ClinicalTrials.gov Identifier: NCT03848247     History of Changes
Other Study ID Numbers: N-20180063_Sub-project_1
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms