Chronic Neck PainNCT03702075
Self-administered Program in Chronic Neck Pain
A study testing self-administered program in people with Chronic Neck Pain, run by Universidad de Granada at 1 site in Spain.
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 are influenced by environmental and personal factors. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- self-administered program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2018to Feb 2019
- 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 3 months' duration) not related to trauma of at least 3 on a visual analogue scale
- Participants' symptoms had to be reproduced by median nerve upper-limb neurodynamic test.
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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Health Sciences. University of Granada.
Granada, Granada, 18071
About this study
Official title: Effects of a Self-administered Program in Chronic Neck Pain Patients
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 are 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
- Chronic Neck Pain
- Being tested
- self-administered program
- Keywords
- chronic neck pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-administered programOther
One session was a session supervised by a physical therapist in the Faculty of Health Sciences. This session took place in groups of three or four people. All participants had to follow the physiotherapist instructions about the correct way to do the exercises with the foam roller or ball and nerve mobilizations of upper limbs.The other two weekly sessions were performed at home, following the instructions given by the physiotherapist in session.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients allocated to the experimental group were included in a self-administered program combining self-myofascial release using foam rollers and roller balls and active upper limb neurodynamic exercises. It consisted of three sessions of 50-60 minutes per week for 4 consecutive weeks. Receives: Other: self-administered program |
| Control group | No intervention | Those patients allocated to the control group received a booklet with information regarding neck pain and explaining basic exercises for active mobilization and stretching with pictures and a short text. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trigger points examination
Trigger points will be explored bilaterally by a blinded assessor in suboccipital, scalene, levator scapulae and upper trapezius muscles
Measured: Change from baseline trigger points examination at 4 weeks
Secondary outcomes (6)
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 4 weeks
Functionality
Functionality will be assessed by the Neck Outcome Score. This is a reliable, valid and responsive measure of self-reported disability for patients with neck pain. It includes 34 items divided into 5 subscales: Mobility, symptoms, sleep disturbance, every day activity and pain and participation in everyday life.
Measured: Change from baseline functionality at 4 weeks
Cervical range of motion
Cervical range of motion will be measured using a cervical goniometer. Subjects perform neck movements to the fullest extent of their mobility of flexion, extension, right and left lateroflexion, and right and left rotation.
Measured: Change from baseline cervical range of motion at 4 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 posted10 Oct 2018
- Study start1 Sep 2018
- Primary completionNov 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- 50 participants (estimated)
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
- NCT03702075
- Sponsor's protocol ID
- DF0080UG
- Status last verified
- Oct 2018
- First submitted
- 8 Oct 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Self-administered Program in Chronic Neck Pain Patients
- ClinicalTrials.gov ID
- NCT03702075
- Acronym / sponsor ID
- DF0080UG
- Conditions
- Chronic Neck Pain
- Keywords
- chronic neck pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 10 Oct 2018 (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.
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 are 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-administered programPatients allocated to the experimental group were included in a self-administered program combining self-myofascial release using foam rollers and roller balls and active upper limb neurodynamic exercises. It consisted of three sessions of 50-60 minutes per week for 4 consecutive weeks. |
| Control group | No intervention | –Those patients allocated to the control group received a booklet with information regarding neck pain and explaining basic exercises for active mobilization and stretching with pictures and a short text. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic neck pain (at least 3 months' duration) not related to trauma of at least 3 on a visual analogue scale
- Participants' symptoms had to be reproduced by median nerve upper-limb neurodynamic test.
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-administered programOne session was a session supervised by a physical therapist in the Faculty of Health Sciences. This session took place in groups of three or four people. All participants had to follow the physiotherapist instructions about the correct way to do the exercises with the foam roller or ball and nerve mobilizations of upper limbs.The other two weekly sessions were performed at home, following the instructions given by the physiotherapist in session. | Other | Experimental group |
Primary outcome
Trigger points examination
Time frame: Change from baseline trigger points examination at 4 weeks
Trigger points will be explored bilaterally by a blinded assessor in suboccipital, scalene, levator scapulae and upper trapezius muscles
6 secondary outcomes
Pain severity
Time frame: Change from baseline pain at 4 weeks
Functionality
Time frame: Change from baseline functionality at 4 weeks
Cervical range of motion
Time frame: Change from baseline cervical range of motion at 4 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-administered program in people with Chronic Neck Pain, run by Universidad de Granada at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
Trigger points examination (time frame: Change from baseline trigger points examination at 4 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 15 Oct 2018.