The Effect of Experimental Neck Pain in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03848247
• Other study ID #: N-20180063_Sub-project_1
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2019
• Est. completion date: May 1, 2019

Study information

• Verified date: February 2019
• Source: Aalborg University
• Contact: Steffan W Christensen, PhD
• Phone: +45 99408889
• Email: stc[@]hst.aau.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Neck Pain

Intervention

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

Locations

Country	Name	City	State
Denmark	Dept. Of Health Science and Technology, SMI, Aalborg University	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pressure pain threshold (PPT) measured with a handheld pressure algometer	PPT will be assessed over head, neck, arm and leg sites.	Day 0, 2,4 and 15
Primary	Change in motor evoked potentials	Trans cranial magnetic stimulation (TMS) is used to asses motor evoked potentials of neck muscles	Day 0, 4 and 15
Primary	Change in Body movement	3D recordings of body movements	Day 0, 4 and 15
Secondary	Change in muscle activity (EMG)	EMG of axioscapular muscles & trunk during arm movements	Day 0, 4 and 15
Secondary	Change in standing balance	Standing balance is measured on a force platform	Day 0, 4 and 15
Secondary	Change in perceived pain: McGill Pain Questionnaire	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.	Day 0, 2,4 and 15
Secondary	Disability	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)	Day 0, 2,4 and 15
Secondary	Pain Catastrophizing Scale (13 item questionnaire)	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.	Day 2
Secondary	The Big Five Inventory (BFI)	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.	Day 2