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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03848247
Enrollment
40
Registered
2019-02-20
Start date
2019-01-21
Completion date
2019-05-01
Last updated
2019-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Neck Pain

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)

Interventions

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).

OTHERInjection of NGF

Half the participants will be injected in a neck muscle with NGF (Neck pain group).

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in pressure pain threshold (PPT) measured with a handheld pressure algometerDay 0, 2,4 and 15PPT will be assessed over head, neck, arm and leg sites.
Change in motor evoked potentialsDay 0, 4 and 15Trans cranial magnetic stimulation (TMS) is used to asses motor evoked potentials of neck muscles
Change in Body movementDay 0, 4 and 153D recordings of body movements

Secondary

MeasureTime frameDescription
Change in perceived pain: McGill Pain QuestionnaireDay 0, 2,4 and 15Pain 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.
DisabilityDay 0, 2,4 and 15Neck 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)
The Big Five Inventory (BFI)Day 2BFI 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.
Pain Catastrophizing Scale (13 item questionnaire)Day 2Pain 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.
Change in muscle activity (EMG)Day 0, 4 and 15EMG of axioscapular muscles & trunk during arm movements
Change in standing balanceDay 0, 4 and 15Standing balance is measured on a force platform

Countries

Denmark

Contacts

Primary ContactSteffan W Christensen, PhD
stc@hst.aau.dk+45 99408889

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026