Neck PainNCT03992495
The Effect of Exercise on Pain Sensitivity in a Population With Ongoing Neck Pain Compared to Healthy Controls
An observational study of Neck Pain and Healthy, run by Aalborg University.
Trial summary
This study investigates the effect of exercise on pain sensitivity in ongoing neck pain patients compared to a healthy control group. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Exercise
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2019to Jan 2021
- Phase
- Observational
- 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
Study population: People with self-reported pain from the neck area with a symptom duration of three months or longer and pain free healthy participants.
Who may be able to join
- Pain free healthy participants
- Able to speak, read and understand Danish and English
- Self reported neck pain lasting three months or longer.
- Able to speak, read and understand Danish and English
- Reduced/painful active range of motion of the head and/or painful reaction to palpation of the neck at the time of inclusion
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 19Show 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
- Shoulder pain during arm movements
- Experience of DOMS during the week leading up to the test session
- Former surgery in neck or shoulder
- Current or previous chronic or recurrent pain condition other than neck pain
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous neurologic, musculoskeletal or mental illnesses
- Abnormally disrupted sleep in the 24 hours preceding the experiment
- Lack of ability to cooperate
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Exercise on Neck Pain and Pain Sensitivity
This study investigates the effect of exercise on pain sensitivity in ongoing neck pain patients compared to a healthy control group.
Read the detailed description
Increased pain sensitivity is a common finding in neck pain patients when compared to healthy controls. Although most studies favor exercise as an intervention, the specific effect on pain sensitivity is still debated. This study will investigate the effect of exercise on pain sensitivity in neck pain patients compared to healthy controls
- Being tested
- Exercise
- Keywords
- Exercise, Neck pain, Pain sensitivity
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
All participants will be exposed to aerobic/strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Neck pain | People suffering from neck pain at the time of recruitment Receives: Other: Exercise | |
| Healthy | Participants with no significant past neck pain, chronic pain or other relevant medical disorders. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain sensitivity
Pain sensitivity will be estimated by determining the pressure pain threshold (PPT) on the neck before and after exercise
Measured: Baseline, 6 weeks, 12 weeks
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 and by drawing perceived painful areas on a body charts
Measured: Baseline, 6 weeks, 12 weeks
Change in disability
Disability will be estimated by scoring the Neck Disability Index (NDI) questionnaire. The questionnaire is designed to help express how neck pain affects your ability to manage everyday activities.(Domains: pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping, recreation). Higher score = high level of disability
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start20 Jun 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 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
- NCT03992495
- Sponsor's protocol ID
- N-20180063_Sub-project_3
- Status last verified
- Jun 2019
- First submitted
- 18 Jun 2019
- Last updated
- 20 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Neck Pain and Pain Sensitivity
- ClinicalTrials.gov ID
- NCT03992495
- Acronym / sponsor ID
- N-20180063_Sub-project_3
- Keywords
- Exercise, Neck pain, Pain sensitivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 20 Jun 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 20 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 the effect of exercise on pain sensitivity in ongoing neck pain patients compared to a healthy control group.
Detailed description
Increased pain sensitivity is a common finding in neck pain patients when compared to healthy controls. Although most studies favor exercise as an intervention, the specific effect on pain sensitivity is still debated. This study will investigate the effect of exercise on pain sensitivity in neck pain patients compared to healthy controls
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neck pain | – | Other: ExercisePeople suffering from neck pain at the time of recruitment |
| Healthy | – | Other: ExerciseParticipants with no significant past neck pain, chronic pain or other relevant medical disorders. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- People with self-reported pain from the neck area with a symptom duration of three months or longer and pain free healthy participants.
Key inclusion criteria (5 listed)
- Pain free healthy participants
- Able to speak, read and understand Danish and English
- Self reported neck pain lasting three months or longer.
- Able to speak, read and understand Danish and English
- Reduced/painful active range of motion of the head and/or painful reaction to palpation of the neck at the time of inclusion
Key exclusion criteria (19 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 |
|---|---|---|
| ExerciseAll participants will be exposed to aerobic/strengthening exercises | Other | Healthy, Neck pain |
Primary outcome
Change in pain sensitivity
Time frame: Baseline, 6 weeks, 12 weeks
Pain sensitivity will be estimated by determining the pressure pain threshold (PPT) on the neck before and after exercise
2 secondary outcomes
Change in perceived pain
Time frame: Baseline, 6 weeks, 12 weeks
Change in disability
Time frame: Baseline, 6 weeks, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Individual participant dataSharing planned: Undecided
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Healthy, run by Aalborg University.
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 5 inclusion and 19 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 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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 (99408889 ext. +45, 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 pain sensitivity (time frame: Baseline, 6 weeks, 12 weeks). 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 20 Jun 2019.