- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03992495
The Effect of Exercise on Pain Sensitivity in a Population With Ongoing Neck Pain Compared to Healthy Controls
June 19, 2019 updated by: Steffan Wittrup Christensen, Aalborg University
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.
Study Overview
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 Type
Observational
Enrollment (Anticipated)
46
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Steffan W Christensen, PhD
- Phone Number: +45 99408889
- Email: stc@hst.aau.dk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria: - Healthy participants
- Pain free healthy participants
- Able to speak, read and understand Danish and English
Exclusion Criteria: - Healthy participants
- 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
Inclusion Criteria: - Neck pain population
- 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
Exclusion Criteria: - Neck pain population
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Neck pain
People suffering from neck pain at the time of recruitment
|
All participants will be exposed to aerobic/strengthening exercises
|
Healthy
Participants with no significant past neck pain, chronic pain or other relevant medical disorders.
|
All participants will be exposed to aerobic/strengthening exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, 6 weeks, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in perceived pain
Time Frame: Baseline, 6 weeks, 12 weeks
|
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
|
Baseline, 6 weeks, 12 weeks
|
Change in disability
Time Frame: Baseline, 6 weeks, 12 weeks
|
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
|
Baseline, 6 weeks, 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body movements
Time Frame: Baseline, 6 weeks, 12 weeks
|
Head repositioning accuracy will be tested using a clinical test in a seated position.
Participants will turn their head to end of range in from a neutral position with their eyes closed and return to the start position again.
The difference between start and end position will be recorded.
Standing balance will be assessed by recording the time (seconds) a tandem stance can be maintained.
|
Baseline, 6 weeks, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 20, 2019
Primary Completion (Anticipated)
October 1, 2020
Study Completion (Anticipated)
January 1, 2021
Study Registration Dates
First Submitted
June 18, 2019
First Submitted That Met QC Criteria
June 19, 2019
First Posted (Actual)
June 20, 2019
Study Record Updates
Last Update Posted (Actual)
June 20, 2019
Last Update Submitted That Met QC Criteria
June 19, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-20180063_Sub-project_3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Exercise
-
University of Kansas Medical CenterRecruiting
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of
-
University of AlbertaWomen and Children's Health Research Institute, CanadaRecruitingType 1 Diabetes | Post-menopauseCanada
-
Uskudar UniversityCompleted
-
Yuksek Ihtisas UniversityCompletedDementia | Frailty | Cognitive Function | Reaction Time | Aerobic Exercise | Balance ExerciseTurkey
-
National Taiwan Normal UniversityCompletedAging | Cognitive DeclineTaiwan
-
Wayne State UniversityUnknown