The Effect of Experimental Neck Pain in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT03848247|
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy Neck Pain||Other: Injection of Isotonic saline Other: Injection of NGF||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
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).
- 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
- Change in muscle activity (EMG) [ Time Frame: Day 0, 4 and 15 ]EMG of axioscapular muscles & trunk during arm movements
- Change in standing balance [ Time Frame: Day 0, 4 and 15 ]Standing balance is measured on a force platform
- 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.
- 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)
- 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.
- 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.
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
|Contact: Steffan W Christensen, PhD||+45 email@example.com|
|Dept. Of Health Science and Technology, SMI, Aalborg University||Recruiting|
|Aalborg, Denmark, 9220|
|Contact: Steffan W Christensen, PhD|
|Principal Investigator:||Steffan W Christensen, PhD||Aalborg University|