- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02904668
Self-management Program in Chronic Neck Pain
October 8, 2018 updated by: Marie Carmen Valenza, Universidad de Granada
Effects of a Self-management Program in Patients With Chronic Neck Pain
Neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck movements or sustained neck postures.
The onset and course of this pain is influenced by environmental and personal factors.Many studies report that participants preferred self-care measures for the management of neck pain and they sought professional help only when those measures fail.
Study Overview
Detailed Description
Neck pain is the fourth leading cause of disability worldwide causing an enormous impact on individuals and their families, communities and healthcare systems.While neck pain can be severely disabling and costly, treatment options have shown moderate evidence of effectiveness.
No previous study has used foam roller in patients with neck pain.
In addition, it has been suggested that neurodynamic interventions provide a peripheral stimulus, reducing the pressure existing within the nerve, improving blood flow, axonal transport and nerve conduction.
It was hypothesized that a self-administered intervention focused on myofascial release of main muscles related to neck pain and upper-limb active neurodynamics could reduce the presence of active trigger points and pain, improving functionality and active mobility.
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chronic neck pain (at least 6 months' duration) not related to trauma .
Exclusion Criteria:
- Whiplash related neck pain
- Previous cervical surgical intervention
- Cognitive impairments which prevent them to follow instructions
- Visual or acoustic limitations
- Physical therapy in the previous six months
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
Patients allocated to the experimental group were included in a self-management program and manual therapy program
|
One session was a session supervised by a physical therapist in the Faculty of Health Sciences.
The program contents were educative information about chronic neck pain and healthy lifestyle habits (application of local heat/cold, and sleeping face down, using correct sitting posture, alternating body position, and using correct lifting technique (…), which were complemented by a problem-based session.
|
Active Comparator: Control group
The intervention consisted of 45-minute manual therapy sessions.
Manual therapy included "hands-on" muscular mobilization techniques (aimed at improving soft tissue function), specific articular mobilization techniques (to improve overall joint function and decrease any restrictions in movement at single or multiple segmental levels in the cervical spine), and coordination or stabilization techniques (to improve postural control, coordination, and movement patterns by using the stabilizing cervical musculature)
|
One session was a session supervised by a physical therapist in the Faculty of Health Sciences.
The program contents were educative information about chronic neck pain and healthy lifestyle habits (application of local heat/cold, and sleeping face down, using correct sitting posture, alternating body position, and using correct lifting technique (…), which were complemented by a problem-based session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disability
Time Frame: Change from baseline pain at 3 weeks
|
Disability will be explored using the Neck Disability Index.
The patients rated their current pain and average pain over the past week on a 0-10 numerical rating scale
|
Change from baseline pain at 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain severity
Time Frame: Change from baseline pain at 3 weeks
|
Pain will be assessed using the Brief Pain Inventory.
It measures the degree of interference of pain with various aspects of life, including mobility and social activities (reactive pain) and pain severity (sensory pain).
|
Change from baseline pain at 3 weeks
|
Health related quality of life
Time Frame: Change from baseline health related quality of life at 4 weeks
|
Health related quality of life will be measured by euroQol-5D.
It contains two sections, a descriptive section and a valuation section.
|
Change from baseline health related quality of life at 4 weeks
|
Fear avoidance beliefs
Time Frame: Change from baseline fear avoidance beliefs at 4 weeks
|
Fear avoidance beliefs will be assessed by the the Fear Avoidance Beliefs Questionnaire (FABQ).
It consists of 16 sentences related to physical activity (first 5 items) and work (last 11 items).
|
Change from baseline fear avoidance beliefs at 4 weeks
|
Anxiety and depression
Time Frame: Change from baseline anxiety and depression at 4 weeks
|
Anxiety and depression was evaluated by the the Hospital Anxiety and Depression Scale (HAD).It contains 14 items describing symptoms of depression (7 items) and anxiety (7 items)
|
Change from baseline anxiety and depression at 4 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
September 1, 2016
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
September 2, 2016
First Submitted That Met QC Criteria
September 13, 2016
First Posted (Estimate)
September 19, 2016
Study Record Updates
Last Update Posted (Actual)
October 10, 2018
Last Update Submitted That Met QC Criteria
October 8, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF0061UG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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
-
Jeff Elias, MDRecruitingCancer of Head and Neck | Pain, Neck | Pain, FaceUnited States
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
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 self-managmeent program
-
Azienda Sanitaria Locale CN1 CuneoNot yet recruiting
-
Radboud University Medical CenterCompleted
-
University of North Carolina, Chapel HillCenters for Disease Control and PreventionCompletedChronic DiseaseUnited States
-
Stanford UniversityNational Institute of Mental Health and Neuro Sciences, IndiaCompleted
-
National University of SingaporeIntellect Pte. Ltd.Completed
-
Assistance Publique - Hôpitaux de ParisRecruitingQuality of Life | Facial Palsy | Motor Recovery | Self-rehabilitationFrance
-
Rush University Medical CenterUniversity of Colorado, Denver; Geisinger Clinic; University of Missouri, Kansas... and other collaboratorsActive, not recruiting
-
Palo Alto Medical FoundationNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); American...CompletedObesity | Metabolic Syndrome | Pre-diabetesUnited States
-
National University of SingaporeIntellect Pte. Ltd.RecruitingObsessive-Compulsive DisorderSingapore