HealthyNCT04001218
Head Repositioning Accuracy During Experimental Neck Pain
A study testing Injection of hypertonic saline and Injection of Isotonic saline 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 neck muscle pain influences head repositioning error in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Injection of hypertonic saline and Injection of Isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Apr 2015to 22 Sep 2015
- 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
- Right handed
- Able to speak, read and understand Danish or English
- Normal pain free neck and shoulder range of motion
Who cannot join
- Pain from the neck or shoulder area
- Prior surgery in neck or shoulder
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Self reported neurologic, musculoskeletal or mental illnesses
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. Of Health Science and Technology, SMI, Aalborg University
Aalborg, 9220
About this study
Official title: Neck Pain - Motor and Sensory Aspects
This study investigates if/how an experimentally applied neck muscle pain influences head repositioning error in healthy participants.
Read the detailed description
Healthy volunteers will participate in a single session study with a crossover design.
During the study healthy participants will be randomized to either receive a injection of hypertonic saline (painful injection) or isotonic saline (control injection) in a neck muscle.
Head repositioning accuracy will be assessed with and without performing a cognitive task.
- Being tested
- Injection of hypertonic saline, Injection of Isotonic saline
- 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 hypertonic salineDrug
Also called Hypertonic saline (5.8%)
Painful condition: Participants will be injected in a neck muscle with 0.5ml of hypertonic saline (5.8%)
Injection of Isotonic salineDrug
Also called Isotonic saline (0.9%)
Control condition: Participants will be injected in a neck muscle with 0.5ml isotonic saline (0.9%)
| Study group | Role | What they receive |
|---|---|---|
| Painful condition | Experimental | Participants will be injected with 0.5ml hypertonic saline (5.8%) into a neck muscle Receives: Drug: Injection of hypertonic saline |
| Control condition | Experimental | Participants will be injected with 0.5ml Isotonic saline (0.9%) into a neck muscle Receives: Drug: Injection of Isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in head repositioning accuracy
Participants will be blindfolded and asked asked to, from a neutral position, to move the head into full range of motion before returning to to a neutral position again. The difference between the start and end position will be used as an estimate of head repositioning error.
Measured: Within session (session lasts approximately 2 hours)
Secondary outcomes (2)
Change in perceived pain
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: Within session (session lasts approximately 2 hours)
Change in perceived performance of head repositioning accuracy test
Likert scores of the perceived difficultness (0=no problems, 1=minimally difficult, 2=somewhat difficult, 3=fairly difficult, 4= very difficult, 5=unable to perform)
Measured: Within session (session lasts approximately 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start9 Apr 2015
- Primary completion22 Sep 2015
- Study completion22 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Model description
- Participants will be randomized to either the painful condition or the control condition first before crossing over to opposite condition.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Rheumatism Association
- 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
- NCT04001218
- Sponsor's protocol ID
- N20120018_Subproject 1d
- Status last verified
- Jun 2019
- First submitted
- 26 Jun 2019
- Last updated
- 28 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neck Pain - Motor and Sensory Aspects
- ClinicalTrials.gov ID
- NCT04001218
- Acronym / sponsor ID
- N20120018_Subproject 1d
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- The Danish Rheumatism Association
- Study start
- 9 Apr 2015 (actual)
- Primary completion
- 22 Sep 2015 (actual)
- Study completion
- 22 Sep 2015 (actual)
- First posted
- 28 Jun 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 neck muscle pain influences head repositioning error in healthy participants.
Detailed description
Healthy volunteers will participate in a single session study with a crossover design.
During the study healthy participants will be randomized to either receive a injection of hypertonic saline (painful injection) or isotonic saline (control injection) in a neck muscle.
Head repositioning accuracy will be assessed with and without performing a cognitive task.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to either the painful condition or the control condition first before crossing over to opposite condition.
| Arm | Type | Receives |
|---|---|---|
| Painful condition | Experimental | Drug: Injection of hypertonic salineParticipants will be injected with 0.5ml hypertonic saline (5.8%) into a neck muscle |
| Control condition | Experimental | Drug: Injection of Isotonic salineParticipants will be injected with 0.5ml Isotonic saline (0.9%) into a neck muscle |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men and women aged 18-50 years
- Right handed
- Able to speak, read and understand Danish or English
- Normal pain free neck and shoulder range of motion
Key exclusion criteria (5 listed)
- Pain from the neck or shoulder area
- Prior surgery in neck or shoulder
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Self reported neurologic, musculoskeletal or mental illnesses
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 hypertonic salineAlso: Hypertonic saline (5.8%)Painful condition: Participants will be injected in a neck muscle with 0.5ml of hypertonic saline (5.8%) | Drug | Painful condition |
| Injection of Isotonic salineAlso: Isotonic saline (0.9%)Control condition: Participants will be injected in a neck muscle with 0.5ml isotonic saline (0.9%) | Drug | Control condition |
Primary outcome
Change in head repositioning accuracy
Time frame: Within session (session lasts approximately 2 hours)
Participants will be blindfolded and asked asked to, from a neutral position, to move the head into full range of motion before returning to to a neutral position again. The difference between the start and end position will be used as an estimate of head repositioning error.
2 secondary outcomes
Change in perceived pain
Time frame: Within session (session lasts approximately 2 hours)
Change in perceived performance of head repositioning accuracy test
Time frame: Within session (session lasts approximately 2 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
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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 hypertonic saline and Injection of Isotonic saline 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 28 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in head repositioning accuracy (time frame: Within session (session lasts approximately 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2019.