HealthyNCT03848247
The Effect of Experimental Neck Pain in Healthy Participants
A study testing Injection of Isotonic saline and Injection of NGF in people with Healthy and Neck Pain, run by Aalborg University at 1 site in Denmark.
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 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Injection of Isotonic saline and Injection of NGF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Jan 2019to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Dept. Of Health Science and Technology, SMI, Aalborg University
Aalborg, 9220
Steffan W Christensen, PhD
About this study
Official title: The Effect of Experimental Neck Pain in Healthy Participants - The Transition From Acute to Ongoing Pain
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
Read the 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)
- Being tested
- Injection of Isotonic saline, Injection of NGF
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of Isotonic salineOther
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 NGFOther
Half the participants will be injected in a neck muscle with NGF (Neck pain group).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Participants will be injected with 0.5ml Isotonic saline into a neck muscle Receives: Other: Injection of Isotonic saline |
| Neck pain | Experimental | Participants will be injected with 0.5ml NGF into the a neck muscle Receives: Other: Injection of NGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pressure pain threshold (PPT) measured with a handheld pressure algometer
PPT will be assessed over head, neck, arm and leg sites.
Measured: Day 0, 2,4 and 15
Change in motor evoked potentials
Trans cranial magnetic stimulation (TMS) is used to asses motor evoked potentials of neck muscles
Measured: Day 0, 4 and 15
Change in Body movement
3D recordings of body movements
Measured: Day 0, 4 and 15
Secondary outcomes (6)
Change in muscle activity (EMG)
EMG of axioscapular muscles \& trunk during arm movements
Measured: Day 0, 4 and 15
Change in standing balance
Standing balance is measured on a force platform
Measured: Day 0, 4 and 15
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.
Measured: Day 0, 2,4 and 15
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)
Measured: Day 0, 2,4 and 15
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.
Measured: Day 2
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.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start21 Jan 2019
- Primary completion1 May 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steffan Wittrup Christensen, Aalborg University
- Investigators
- Steffan W Christensen, PhD, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848247
- Sponsor's protocol ID
- N-20180063_Sub-project_1
- Status last verified
- Feb 2019
- First submitted
- 16 Feb 2019
- Last updated
- 21 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Simonsen MB, Cancino EE, de Brito Silva P, Sorensen LB, Hirata RP, Christensen SWM. The impact of prolonged experimental neck pain on walking stability and gait kinematics - A parallel-group study. Clin Biomech (Bristol). 2023 Jan;101:105869. doi: 10.1016/j.clinbiomech.2022.105869. Epub 2022 Dec 23.
PubMed 36584579
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Experimental Neck Pain in Healthy Participants - The Transition From Acute to Ongoing Pain
- ClinicalTrials.gov ID
- NCT03848247
- Acronym / sponsor ID
- N-20180063_Sub-project_1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Other: Injection of Isotonic salineParticipants will be injected with 0.5ml Isotonic saline into a neck muscle |
| Neck pain | Experimental | Other: Injection of NGFParticipants will be injected with 0.5ml NGF into the a neck muscle |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of Isotonic salineHalf the participants will be injected in a neck muscle with isotonic saline (Control group) and the other half will get NGF (Neck pain group). | Other | Control group |
| Injection of NGFHalf the participants will be injected in a neck muscle with NGF (Neck pain group). | Other | Neck pain |
Primary outcome
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
6 secondary outcomes
Change in muscle activity (EMG)
Time frame: Day 0, 4 and 15
Change in standing balance
Time frame: Day 0, 4 and 15
Change in perceived pain: McGill Pain Questionnaire
Time frame: Day 0, 2,4 and 15
Disability
Time frame: Day 0, 2,4 and 15
Pain Catastrophizing Scale (13 item questionnaire)
Time frame: Day 2
The Big Five Inventory (BFI)
Time frame: Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Derived from this study: PubMed 36584579Simonsen MB, Cancino EE, de Brito Silva P, Sorensen LB, Hirata RP, Christensen SWM. The impact of prolonged experimental neck pain on walking stability and gait kinematics - A parallel-group study. Clin Biomech (Bristol). 2023 Jan;101:105869. doi: 10.1016/j.clinbiomech.2022.105869. Epub 2022 Dec 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffan W Christensen, PhD principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of Isotonic saline and Injection of NGF in people with Healthy and Neck Pain, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steffan W Christensen, PhD (+45 99408889, stc@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pressure pain threshold (PPT) measured with a handheld pressure algometer (time frame: Day 0, 2,4 and 15). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03848247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.