The Effect of Experimental Neck Pain in Healthy Participants
- Conditions
- Neck PainHealthy
- Interventions
- Other: Injection of Isotonic salineOther: Injection of NGF
- Registration Number
- NCT03848247
- Lead Sponsor
- 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
- 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)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Injection of Isotonic saline Participants will be injected with 0.5ml Isotonic saline into a neck muscle Neck pain Injection of NGF Participants will be injected with 0.5ml NGF into the a neck muscle
- Primary Outcome Measures
Name Time Method Change in motor evoked potentials Day 0, 4 and 15 Trans cranial magnetic stimulation (TMS) is used to asses motor evoked potentials of neck muscles
Change in pressure pain threshold (PPT) measured with a handheld pressure algometer Day 0, 2,4 and 15 PPT will be assessed over head, neck, arm and leg sites.
Change in Body movement Day 0, 4 and 15 3D recordings of body movements
- Secondary Outcome Measures
Name Time Method The Big Five Inventory (BFI) 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.
Change in standing balance Day 0, 4 and 15 Standing balance is measured on a force platform
Disability 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) 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.Change in muscle activity (EMG) Day 0, 4 and 15 EMG of axioscapular muscles \& trunk during arm movements
Change in perceived pain: McGill Pain Questionnaire 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.
Trial Locations
- Locations (1)
Dept. Of Health Science and Technology, SMI, Aalborg University
🇩🇰Aalborg, Denmark