- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03362333
Pain Neuroscience Education and Exercise
Pain Neuroscience Education and Exercise Versus Exercise for University Students With Chronic Idiopathic Neck Pain: a Randomized, Controlled and Single Blind Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain.
University students with chronic neck pain were randomly allocated to receive pain neuroscience education and exercise or exercise only and assessed at baseline, after the intervention and at 3 months follow up. Outcome variables were pain intensity (primary outcome), disability, fear of movement, catastrophizing, knowledge of pain neurophysiology, pressure pain thresholds and neck and scapular muscle endurance.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants could enter the study if they had chronic idiopathic neck pain, defined as pain felt in the neck at least once a week in the previous 3 months and for which no cause had been established. Furthermore, they were required to have a minimum pain intensity in the previous week of 2 in the visual analogue scale.
Exclusion Criteria:
- Participants were excluded if they had had physiotherapy for their neck pain in the 6 months previous to the study, if they had rheumatic, nervous, cardiac and/or respiratory pathology that could prevent or make it difficult to do the exercises. Exclusion criteria were ascertained by self-report.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pain neuroscience education and exercise
This group received pain neuroscience education and exercise once a week over 4 weeks
|
Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular stabilizer muscles.
Pain neuroscience education covered the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience.
|
Active Comparator: Exercise
This group received exercise directed at the neck and shoulder regions once a week over 4 weeks
|
Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular stabilizer muscles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: At the beginning
|
Measured using the visual analogue scale
|
At the beginning
|
Pain intensity
Time Frame: 5 weeks
|
Measured using the visual analogue scale
|
5 weeks
|
Pain intensity
Time Frame: At 3 months
|
Measured using the visual analogue scale
|
At 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Deep neck flexor endurance
Time Frame: At the beginning
|
Method of assessment - physical test; the participant is in supine and he/she is asked to flex the upper cervical spine, move their head away from the couch approximately 2.5 cm and then maintain this position for as long as possible.
The test result is the time (in seconds) that each participant holds the position.
|
At the beginning
|
Deep neck flexor endurance
Time Frame: 5 weeks
|
Method of assessment - physical test; the participant is in supine and he/she is asked to flex the upper cervical spine, move their head away from the couch approximately 2.5 cm and then maintain this position for as long as possible.
The test result is the time (in seconds) that each participant holds the position.
|
5 weeks
|
Neck extensors endurance
Time Frame: At the beginning
|
Method of assessment - physical test; the participant is in prone and position, head neutral, and supporting 2 Kg weight hanging from it.
Participants were asked to support this weight for as long as possible while maintaining the neutral head positioning.
The test result is the time (in seconds) that each participant holds the position.
|
At the beginning
|
Neck extensors endurance
Time Frame: 5 weeks
|
Method of assessment - physical test; the participant is in prone and position, head neutral, and supporting 2 Kg weight hanging from it.
Participants were asked to support this weight for as long as possible while maintaining the neutral head positioning.
The test result is the time (in seconds) that each participant holds the position.
|
5 weeks
|
Scapular stabilizers endurance
Time Frame: At the beginning
|
Method of assessment - physical test; Method of assessment - physical test; Participants were standing with the shoulders and elbows flexed at 90º, while pulling both extremities of a dynamometer to reach 1 Kg of force.
The test result is the time (in seconds) that each participants was able to hold this position.
|
At the beginning
|
Scapular stabilizers endurance
Time Frame: 5 weeks
|
Method of assessment - physical test; Method of assessment - physical test; Participants were standing with the shoulders and elbows flexed at 90º, while pulling both extremities of a dynamometer to reach 1 Kg of force.
The test result is the time (in seconds) that each participants was able to hold this position.
|
5 weeks
|
Pressure pain thresholds
Time Frame: At the beginning
|
Method of assessment - psychophysical test; Pressure was applied over the trapezius and at C5-C6 with a algometer until the participant first felt pain.
The results was the quantity of force (in Kgf) supported by participants.
|
At the beginning
|
Pressure pain thresholds
Time Frame: 5 weeks
|
Method of assessment - psychophysical test; Pressure was applied over the trapezius and at C5-C6 with a algometer until the participant first felt pain.
The results was the quantity of force (in Kgf) supported by participants.
|
5 weeks
|
Disability
Time Frame: At the beginning
|
Method of assessment - the neck pain disability index
|
At the beginning
|
Disability
Time Frame: 5 weeks
|
Method of assessment - the neck pain disability index
|
5 weeks
|
Disability
Time Frame: 3 months
|
Method of assessment - the neck pain disability index
|
3 months
|
catastrophizing
Time Frame: at beginning
|
Method of assessment - Pain catastrophising scale
|
at beginning
|
catastrophizing
Time Frame: 5 weeks
|
Method of assessment - Pain catastrophising scale
|
5 weeks
|
catastrophizing
Time Frame: 3 months
|
Method of assessment - Pain catastrophising scale
|
3 months
|
fear of movement
Time Frame: At the beginning
|
method of assessment - the Tampa Scale
|
At the beginning
|
fear of movement
Time Frame: 5 weeks
|
method of assessment - the Tampa Scale
|
5 weeks
|
fear of movement
Time Frame: 3 months
|
method of assessment - the Tampa Scale
|
3 months
|
Knowledge of pain neurophysiology
Time Frame: at beginning
|
method of assessment - scale; the neurophysiology of pain questionnaire
|
at beginning
|
Knowledge of pain neurophysiology
Time Frame: 5 weeks
|
method of assessment - scale; the neurophysiology of pain questionnaire
|
5 weeks
|
Knowledge of pain neurophysiology
Time Frame: 3 months
|
method of assessment - scale; the neurophysiology of pain questionnaire
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anabela Silva, PhD, University of Aveiro
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCEDCSS-FMUP 18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Neck Pain
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
Jeff Elias, MDRecruitingCancer of Head and Neck | Pain, Neck | Pain, FaceUnited States
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Riphah International UniversityCompletedCervical Pain | Mechanical Neck PainPakistan
-
Riphah International UniversityCompleted
-
Instituto Brasileiro de OsteopatiaCompletedNeck Pain | Pain, NeckBrazil
-
Ankara UniversityCompleted
-
Josue Fernandez CarneroCentro Universitario La SalleCompleted
-
Sakarya UniversityUnknown
-
Shanghai University of Traditional Chinese MedicineBeijing Hospital; Dongzhimen Hospital, Beijing; Traditional Chinese Medicine... and other collaboratorsNot yet recruiting
Clinical Trials on Exercise
-
University of Kansas Medical CenterRecruiting
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
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