Neck PainCNSNPNCT04330573
Sensory Characteristics and Psychosocial Factors Related With Non-specific Neck Musculoskeletal Pain Chronification
An observational study of Neck Pain, run by Universidad San Jorge at 1 site in Spain.
Trial summary
Chronic pain is commonly defined as any pain which lasts more than 12 weeks. Chronic non-specific neck pain (CNSNP) has no specific underlying disease causing the pain. There are neurophysiological factors that may modulate pain response and perception in the central nervous system, producing sensory changes such as… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 15 Apr 2020to 22 Jan 2021
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study was divided into 2 groups: individuals with Chronic Non-Specific Neck Pain and healthy controls.
Who may be able to join
- age between 18 and 65 years;
- capable to understand, write, and speak in Spanish;
- having suffered neck pain during the last 12 weeks at least;
- pain localized in the neck region with or without pain radiation;
- Negative Spurling test;
- Negative Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS);
- Negative Upper Limb Tension Test for the median nerve;
- PainDetect test with non-neuropathic pain result. .
Who cannot join
- Presence of red flag as reported in the medical history (i.e. tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis);
- Neck pain with cervical radiculopathy;
- fibromyalgia syndrome,
- previous neck surgery;
- currently undergoing any type of pain treatment or having received physical therapy in the previous 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic pain is commonly defined as any pain which lasts more than 12 weeks. Chronic non-specific neck pain (CNSNP) has no specific underlying disease causing the pain. There are neurophysiological factors that may modulate pain response and perception in the central nervous system, producing sensory changes such as the presence of temporal summation (TS) and pressure, cold or heat hyperalgesia. TS describes the progressive increase in reported pain intensity as a function of repeated noxious stimulation (e.g. thermal, electrical or mechanical). TS and hyperalgesia are measured through quantitative sensory tests (QST) where pain pressure thresholds (PPT) are measured with an algometer. The current evidence show that PPTs are significantly lower compared to healthy subjects and the association between PPTs, pain intensity and disability are inconsistent. Further, there are psychosocial factors (catastrophizing, kinesiophobia, stress…) that may influence the pain experience. This psychosocial factors associated with chronic pain are not systematically collected in the QST literature complicating the interpretation of data. The objectives of this study are 1) to determine disability, sensory (TS and PPTs) and psychosocial changes (kinesiophobia, catastrophizing, sleep quality, life quality, stress and anxiety) in the natural evolution or in the result of physiotherapy treatment in CNSNP individuals, 2) to study the correlations between disability, psychosocial and sensory factors and 3) to observe if there is a homogeneity between the subjects.
- Conditions
- Neck Pain
- Being tested
- No intervention. Observational study
- Keywords
- chronic non-specific neck pain, musculoskeletal pain, psychosocial factors, sensory characteristics, pressure pain thresholds, temporal summation
- Medical subject headings
- Neck Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. Observational studyOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| Chronic Non-Specific Neck Pain | Patients with chronic non-specific neck pain. No interventions Receives: Other: No intervention. Observational study | |
| Control/Healthy Group | Volunteers without pain. No interventions. Receives: Other: No intervention. Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index Change
It is a 10-item questionnaire that measures a patient's self-reported neck pain related disability. Questions include activities of daily living, such as: personal care, lifting, reading, work, driving, sleeping, recreational activities, pain intensity, concentration and headache. The 10 item scores are then summed to yield a global NDI score, which has a range of 0-50 where higher values reflect greater neck disability. 1 and 6-month results were subtracted from baseline. As such, positive change scores for neck disability indicate improvement
Measured: T0 (baseline); T1 (1 month); T2 (6 months).
Quick-DASH change
The purpose of the QuickDASH is to use 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The QuickDASH is a widely used reference of self reported disability. The 11 item scores are then summed to yield a global QuickDASH score, which has a range of 11-100 where higher values reflect greater shoulder/arm disability. 1 and 6-month results were subtracted from baseline. As such, positive change scores for shoulder/arm disability indicate improvement
Measured: T0 (baseline); T1 (1 month); T2 (6 months).
Secondary outcomes (11)
Pressure Pain Threshold change
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom.
Measured: T0 (baseline); T1 (1 month); T2 (6 months).
Temporal Summation change
Temporal summation is a clinical measure of central sensitization in which a high frequency of action potentials in the presynaptic neuron elicits postsynaptic potentials that overlap and summate with each other.
Measured: T0 (baseline); T1 (1 month); T2 (6 months).
Area of pain assessed by bodycharts change
Participants have to draw on a tablet-based digital body chart (NavigatePain©, Aalborg University, Aalborg, Denmark) the body region in which they felt pain more frequently during the previous month. The use of pain drawings has been found to be reliable in chronic low back, neck, shoulder, and arm pain. Digital pain drawings have also been shown reliable, valid and comparable to paper drawings and useful in clinical population. The size of the pain area was extracted and expressed in pixels.
Measured: T0 (baseline); T1 (1 month); T2 (6 months).
Pain Intensity change- Visual Analogic Scale
Self-perceived neck pain will record using a Visual Analogue Scale (VAS). Participants have to mark on a 10-cm line their average current neck pain between 0 ("no pain") and 10 ("worst possible pain"). The VAS is a reliable and valid measurement of pain
Measured: T0 (baseline); T1 (1 month); T2 (6 months).
Pain Duration change
Duration of pain in months
Measured: T0 (baseline); T1 (1 month); T2 (6 months).
Catastrophism change. Pain Catastrophizing Scale
People are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness.
Measured: T0 (baseline); T1 (1 month); T2 (6 months).
Kinesiophobia change. Tampa Scale for Kinesiophobia
Tampa Scale for Kinesiophobia (TSK) The TSK is a 17-item self-report measure of fear of movement and (re)injury. Four of the items are negatively worded and reversed scored (4, 8, 12, and 16). Ratings are summed to yield a total score where higher values reflect greater fear of (re)injury. The 17 item scores are then summed to yield a global TSK score, which has a range of 11-44.
Measured: T0 (baseline); T1 (1 month); T2 (6 months).
Quality of Life change. The 5-level EQ-5D version (EQ-5D-5L)
The EQ-5D is a frequently used generic quality of life questionnaire, designed by the EuroQoL. The EQ-5D-5L is an instrument widely used to measure and evaluate general health status. The EQ-5D-5L descriptive system describes general health in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, indicating no problems, slight problems, moderate problems, severe problems, and extreme problems resulting in a total of 3,125 unique health states. Besides, the EQ-5D-5L also includes a visual analogue scale (EQ-VAS), which recorded the patient's self-rated health on a 20 cm vertical, visual analogue scale with endpoints (0; 100) labeled 'the best health you can imagine' and 'the worst health you can imagine'
Measured: T0 (baseline); T1 (1 month); T2 (6 months).
Stress change. Perceived Stress Scale
he Perceived Stress Scale (PSS) inquire about feelings and thoughts that tap the degree to which respondents find their current life situation unpredictable, uncontrollable and stressful. Respondents indicate how often in the past month they have felt or thought a certain way on a 5-point Likert scale (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). The higher the score the higher the perceived stress is. The 14 item scores are then summed to yield a global PSS score, which has a range of 0-56
Measured: T0 (baseline); T1 (1 month); T2 (6 months).
Quality of Sleep change . Pittsburgh Questionnaire
PSQI consists of 19 self-rated questions. The 19 self-rated questions asses a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep-related problems. Theses 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores indicate worse sleep quality.
Measured: T0 (baseline); T1 (1 month); T2 (6 months).
Anxiety-Depression change. DASS 21.
The DASS is a self-report measure, designed to assess the unique and unrelated aspects of anxiety and depression, as well as a third construct (termed stress) that assesses the features common to anxiety and depression. The DASS-21 is comprised of three scales, Depression, Anxiety, and Stress, each of which consists of 7 items. The 21 item scores are then summed to yield a global DASS-21 score, which has a range of 0-63
Measured: T0 (baseline); T1 (1 month); T2 (6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start15 Apr 2020
- Primary completion15 Dec 2020
- Study completion22 Jan 2021
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General de la Defensa en Zaragoza
- Responsible party
- Principal investigator, Pablo Herrero Gallego, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330573
- Sponsor's protocol ID
- CNSNP-USJ
- Acronym
- CNSNP
- Status last verified
- Jan 2021
- First submitted
- 25 Mar 2020
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be provided based on request to authors by email to gortego@usj.es
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Characteristics and Psychosocial Factors Related With Non-specific Neck Musculoskeletal Pain Chronification
- ClinicalTrials.gov ID
- NCT04330573
- Acronym / sponsor ID
- CNSNP / CNSNP-USJ
- Conditions
- Neck Pain
- Keywords
- chronic non-specific neck pain, musculoskeletal pain, psychosocial factors, sensory characteristics, pressure pain thresholds, temporal summation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Collaborators
- Hospital General de la Defensa en Zaragoza
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 1 Apr 2020 (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.
Chronic pain is commonly defined as any pain which lasts more than 12 weeks. Chronic non-specific neck pain (CNSNP) has no specific underlying disease causing the pain. There are neurophysiological factors that may modulate pain response and perception in the central nervous system, producing sensory changes such as the presence of temporal summation (TS) and pressure, cold or heat hyperalgesia. TS describes the progressive increase in reported pain intensity as a function of repeated noxious stimulation (e.g. thermal, electrical or mechanical). TS and hyperalgesia are measured through quantitative sensory tests (QST) where pain pressure thresholds (PPT) are measured with an algometer. The current evidence show that PPTs are significantly lower compared to healthy subjects and the association between PPTs, pain intensity and disability are inconsistent. Further, there are psychosocial factors (catastrophizing, kinesiophobia, stress…) that may influence the pain experience. This psychosocial factors associated with chronic pain are not systematically collected in the QST literature complicating the interpretation of data. The objectives of this study are 1) to determine disability, sensory (TS and PPTs) and psychosocial changes (kinesiophobia, catastrophizing, sleep quality, life quality, stress and anxiety) in the natural evolution or in the result of physiotherapy treatment in CNSNP individuals, 2) to study the correlations between disability, psychosocial and sensory factors and 3) to observe if there is a homogeneity between the subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Non-Specific Neck Pain | – | Other: No intervention. Observational studyPatients with chronic non-specific neck pain. No interventions |
| Control/Healthy Group | – | Other: No intervention. Observational studyVolunteers without pain. No interventions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study was divided into 2 groups: individuals with Chronic Non-Specific Neck Pain and healthy controls.
Key inclusion criteria (8 listed)
- age between 18 and 65 years;
- capable to understand, write, and speak in Spanish;
- having suffered neck pain during the last 12 weeks at least;
- pain localized in the neck region with or without pain radiation;
- Negative Spurling test;
Key exclusion criteria (5 listed)
- Presence of red flag as reported in the medical history (i.e. tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis);
- Neck pain with cervical radiculopathy;
- fibromyalgia syndrome,
- previous neck surgery;
- currently undergoing any type of pain treatment or having received physical therapy in the previous 3 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 |
|---|---|---|
| No intervention. Observational studyObservational study | Other | Chronic Non-Specific Neck Pain, Control/Healthy Group |
Primary outcome
Neck Disability Index Change
Time frame: T0 (baseline); T1 (1 month); T2 (6 months).
It is a 10-item questionnaire that measures a patient's self-reported neck pain related disability. Questions include activities of daily living, such as: personal care, lifting, reading, work, driving, sleeping, recreational activities, pain intensity, concentration and headache. The 10 item scores are then summed to yield a global NDI score, which has a range of 0-50 where higher values reflect greater neck disability. 1 and 6-month results were subtracted from baseline. As such, positive change scores for neck disability indicate improvement
Quick-DASH change
Time frame: T0 (baseline); T1 (1 month); T2 (6 months).
The purpose of the QuickDASH is to use 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The QuickDASH is a widely used reference of self reported disability. The 11 item scores are then summed to yield a global QuickDASH score, which has a range of 11-100 where higher values reflect greater shoulder/arm disability. 1 and 6-month results were subtracted from baseline. As such, positive change scores for shoulder/arm disability indicate improvement
11 secondary outcomes
Pressure Pain Threshold change
Time frame: T0 (baseline); T1 (1 month); T2 (6 months).
Temporal Summation change
Time frame: T0 (baseline); T1 (1 month); T2 (6 months).
Area of pain assessed by bodycharts change
Time frame: T0 (baseline); T1 (1 month); T2 (6 months).
Pain Intensity change- Visual Analogic Scale
Time frame: T0 (baseline); T1 (1 month); T2 (6 months).
Pain Duration change
Time frame: T0 (baseline); T1 (1 month); T2 (6 months).
Catastrophism change. Pain Catastrophizing Scale
Time frame: T0 (baseline); T1 (1 month); T2 (6 months).
Kinesiophobia change. Tampa Scale for Kinesiophobia
Time frame: T0 (baseline); T1 (1 month); T2 (6 months).
Quality of Life change. The 5-level EQ-5D version (EQ-5D-5L)
Time frame: T0 (baseline); T1 (1 month); T2 (6 months).
Stress change. Perceived Stress Scale
Time frame: T0 (baseline); T1 (1 month); T2 (6 months).
Quality of Sleep change . Pittsburgh Questionnaire
Time frame: T0 (baseline); T1 (1 month); T2 (6 months).
Anxiety-Depression change. DASS 21.
Time frame: T0 (baseline); T1 (1 month); T2 (6 months).
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 25 Jan 2021.
- Individual participant dataSharing planned: No. Data will be provided based on request to authors by email to gortego@usj.es
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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?
An observational study of Neck Pain, run by Universidad San Jorge 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 8 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 25 Jan 2021. 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?
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?
Neck Disability Index Change (time frame: T0 (baseline); T1 (1 month); T2 (6 months).). The study lists 2 primary outcomes in all. 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 25 Jan 2021.