Neck PainNCT02904668
Self-management Program in Chronic Neck Pain
A study testing self-managmeent program in people with Neck Pain, run by Universidad de Granada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- self-managmeent program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic neck pain (at least 6 months' duration) not related to trauma .
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- self-managmeent program
- Keywords
- chronic pain
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-managmeent programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients allocated to the experimental group were included in a self-management program and manual therapy program Receives: Other: self-managmeent program |
| Control group | Active comparator | 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) Receives: Other: self-managmeent program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
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
Measured: Change from baseline pain at 3 weeks
Secondary outcomes (4)
Pain severity
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).
Measured: Change from baseline pain at 3 weeks
Health related quality of life
Health related quality of life will be measured by euroQol-5D. It contains two sections, a descriptive section and a valuation section.
Measured: Change from baseline health related quality of life at 4 weeks
Fear avoidance beliefs
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).
Measured: Change from baseline fear avoidance beliefs at 4 weeks
Anxiety and depression
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)
Measured: Change from baseline anxiety and depression at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2016
- Study completionDec 2016
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904668
- Sponsor's protocol ID
- DF0061UG
- Status last verified
- Oct 2018
- First submitted
- 2 Sep 2016
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Self-management Program in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT02904668
- Acronym / sponsor ID
- DF0061UG
- Conditions
- Neck Pain
- Keywords
- chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Sep 2016 (estimated)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: self-managmeent programPatients allocated to the experimental group were included in a self-management program and manual therapy program |
| Control group | Active comparator | Other: self-managmeent programThe 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic neck pain (at least 6 months' duration) not related to trauma .
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| self-managmeent programOne 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. | Other | Control group, Experimental group |
Primary outcome
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
4 secondary outcomes
Pain severity
Time frame: 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
Fear avoidance beliefs
Time frame: Change from baseline fear avoidance beliefs at 4 weeks
Anxiety and depression
Time frame: Change from baseline anxiety and depression at 4 weeks
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 10 Oct 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing self-managmeent program in people with Neck Pain, run by Universidad de Granada.
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 1 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 10 Oct 2018. 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?
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?
Disability (time frame: Change from baseline pain at 3 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 10 Oct 2018; AzTrials last refreshed its copy on 26 Oct 2026.