Neck PainNCT02629276
Somatosensory Phenotype of Patients Suffering From Unspecific Neck and Arm Pain
An observational study of Neck Pain, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
The aim of this study was to evaluate potential differences in somatosensory function in patients with unilateral NSNAP with and without positive ND compared to healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain
- What is being tested?
- neurodynamic testing
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2014to Jan 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients (woman and men) with unilateral non specific neck-arm pain are recruited from the Centre of Pain Medicine outpatient departments of the Swiss Paraplegic Centre in Nottwil. A standard bedside neurological examination (light touch, muscle strength and reflexes) and standard electro-diagnostic tests (distal ulnar and median sensory and motor latencies and amplitudes, F-waves) are performed to exclude patients with a specific neurological cause for their symptoms (e.g., cervical radiculopathies, myelopathies)
Who may be able to join
- unilateral non specific neck-arm pain
Who cannot join
- specific neck-arm pain (e.g., cervical radiculopathies, myelopathies)
- underlying diseases (e.g, central neurological condition, metabolic disease)
- upper limb or spinal surgery or significant trauma in the preceding two years
- manifest psychiatric or mental diseases
- insufficient German language skills
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Somatosensory Profiles in Patients With Non Specific Neck Arm Pain With and Without Positive Neurodynamic Tests
The aim of this study was to evaluate potential differences in somatosensory function in patients with unilateral NSNAP with and without positive ND compared to healthy controls. Furthermore, we determined whether there are any differences between groups in symptom severity, functional deficits, psychological parameters, quality of life and sleep.
Read the detailed description
Neck pain is a common musculoskeletal problem, with up to 30-50 % of adults experiencing neck pain in any given year. Neck pain in combination with arm pain is more common than neck pain alone and is associated with higher Ievels of self-reported disability and psychological impairment. In most cases, no pathophysiological correlate can be found in various investigations including magnetic resonance imaging of the cervical spine and tests for nerve conductivity (bedside neurological examination and standard electro diagnostic tests). In such cases, the neck-arm pain is labelled as non-specific. Although clinical examinations that evaluate the conductivity of the nervous system are normal in non-specific neck-arm pain (NSNAP), neurodynamic tests (ND) have been identified as positive in a subgroup of patients. ND are clinical tools designed to elongate the nerve bed, therefore increasing the mechanical loading of neural tissues. As such, ND provide information about alterations of neural tissue mechanosensitivity, i.e. the presence of heightened nerve mechanosensitivity. It is assumed that increased neural mechanosensitivity reflects gain of function, presumably mediated by small nociceptive fibres intraneurally or within the epineurium (nervi nervorum). However, it remains unclear whether the subgroup of patients with NSNAP and positive ND have indeed increased gain of function of this small fibre population compared to those patients with normal ND.
Quantitative sensory testing (QST) is a commonly used tool to determine the function of different subsets of small (C, Ad-fibres) and large nerve fibres (Ad-fibres). Using QST, a recent study has identified a loss of small fibre function in patients with unilateral NSNAP and positive ND as apparent by reduced warm detection thresholds compared to the non-affected side. However, this difference was small and potentially not clinically rele-vant and the relatively small sample size of n=8 does not allow generalization of the results. In the same study, patients with NSNAP were also characterized by a gain of function, i.e. cold hypersensitivity. Similarly, widespread thermal and pressure hypersensitivity have been documented in patients with nonspecific arm pain (with or without neck pain). None of these studies has however investigated a potential difference between patients with NSNAP with positive versus negative ND, leaving it unclear whether the QST findings can indeed be attributed to a positive ND.
A recent study compared patients with NSNAP and neuropathic features using ND testing and a self report neuropathic pain screening tool and patients with NSNAP and no neuropathic features. Interestingly, the first group showed heightened nerve mechanosensitivity apparent by an earlier onset of symptoms during ND testing. This raises the question whether patients with NSNAP and positive ND have indeed a dysfunction of their nervous system that differentiates them from patients with normal ND.
- Conditions
- Neck Pain
- Being tested
- neurodynamic testing
- Keywords
- neck pain, arm pain, neurodynamic tests, quantitative sensory testing, somatosensory profile
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurodynamic testingOther
What is being measured
The primary outcome is the main question the study is designed to answer.
mechanosensitivity of neural tissue in neurodynamic testing
Measured: at enrolment
Secondary outcomes (10)
sensation thresholds for cold and warm temperatures in quantitative sensory testing
Measured: at enrolment
pain thresholds for cold and warm temperatures in quantitative sensory testing
Measured: at enrolment
vibration sensation threshold in quantitative sensory testing
Measured: at enrolment
disability due to neck pain
neck disability index questionnaire
Measured: at enrolment
presence of neuropathic pain
neuropathic pain symptom inventory questionnaire
Measured: at enrolment
presence of anxiety
hospital anxiety and depression scale questionnaire
Measured: at enrolment
presence of depression
hospital anxiety and depression scale questionnaire
Measured: at enrolment
insomnia severity
insomnia severity index questionnaire
Measured: at enrolment
sleep quality
visual analogue scale
Measured: at enrolment
presence of pain catastrophizing
pain catastrophizing scale questionnaire
Measured: at enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startAug 2014
- Primary completionDec 2016
- Study completionJan 2017
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 only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Gunther Landmann, Study director, Swiss Paraplegic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629276
- Sponsor's protocol ID
- 2014-12
- Status last verified
- Jan 2017
- First submitted
- 7 Dec 2015
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatosensory Profiles in Patients With Non Specific Neck Arm Pain With and Without Positive Neurodynamic Tests
- ClinicalTrials.gov ID
- NCT02629276
- Acronym / sponsor ID
- 2014-12
- Conditions
- Neck Pain
- Keywords
- neck pain, arm pain, neurodynamic tests, quantitative sensory testing, somatosensory profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Aug 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 14 Dec 2015 (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.
The aim of this study was to evaluate potential differences in somatosensory function in patients with unilateral NSNAP with and without positive ND compared to healthy controls. Furthermore, we determined whether there are any differences between groups in symptom severity, functional deficits, psychological parameters, quality of life and sleep.
Detailed description
Neck pain is a common musculoskeletal problem, with up to 30-50 % of adults experiencing neck pain in any given year. Neck pain in combination with arm pain is more common than neck pain alone and is associated with higher Ievels of self-reported disability and psychological impairment. In most cases, no pathophysiological correlate can be found in various investigations including magnetic resonance imaging of the cervical spine and tests for nerve conductivity (bedside neurological examination and standard electro diagnostic tests). In such cases, the neck-arm pain is labelled as non-specific. Although clinical examinations that evaluate the conductivity of the nervous system are normal in non-specific neck-arm pain (NSNAP), neurodynamic tests (ND) have been identified as positive in a subgroup of patients. ND are clinical tools designed to elongate the nerve bed, therefore increasing the mechanical loading of neural tissues. As such, ND provide information about alterations of neural tissue mechanosensitivity, i.e. the presence of heightened nerve mechanosensitivity. It is assumed that increased neural mechanosensitivity reflects gain of function, presumably mediated by small nociceptive fibres intraneurally or within the epineurium (nervi nervorum). However, it remains unclear whether the subgroup of patients with NSNAP and positive ND have indeed increased gain of function of this small fibre population compared to those patients with normal ND.
Quantitative sensory testing (QST) is a commonly used tool to determine the function of different subsets of small (C, Ad-fibres) and large nerve fibres (Ad-fibres). Using QST, a recent study has identified a loss of small fibre function in patients with unilateral NSNAP and positive ND as apparent by reduced warm detection thresholds compared to the non-affected side. However, this difference was small and potentially not clinically rele-vant and the relatively small sample size of n=8 does not allow generalization of the results. In the same study, patients with NSNAP were also characterized by a gain of function, i.e. cold hypersensitivity. Similarly, widespread thermal and pressure hypersensitivity have been documented in patients with nonspecific arm pain (with or without neck pain). None of these studies has however investigated a potential difference between patients with NSNAP with positive versus negative ND, leaving it unclear whether the QST findings can indeed be attributed to a positive ND.
A recent study compared patients with NSNAP and neuropathic features using ND testing and a self report neuropathic pain screening tool and patients with NSNAP and no neuropathic features. Interestingly, the first group showed heightened nerve mechanosensitivity apparent by an earlier onset of symptoms during ND testing. This raises the question whether patients with NSNAP and positive ND have indeed a dysfunction of their nervous system that differentiates them from patients with normal ND.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (woman and men) with unilateral non specific neck-arm pain are recruited from the Centre of Pain Medicine outpatient departments of the Swiss Paraplegic Centre in Nottwil. A standard bedside neurological examination (light touch, muscle strength and reflexes) and standard electro-diagnostic tests (distal ulnar and median sensory and motor latencies and amplitudes, F-waves) are performed to exclude patients with a specific neurological cause for their symptoms (e.g., cervical radiculopathies, myelopathies)
Key inclusion criteria (1 listed)
- unilateral non specific neck-arm pain
Key exclusion criteria (5 listed)
- specific neck-arm pain (e.g., cervical radiculopathies, myelopathies)
- underlying diseases (e.g, central neurological condition, metabolic disease)
- upper limb or spinal surgery or significant trauma in the preceding two years
- manifest psychiatric or mental diseases
- insufficient German language skills
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 |
|---|---|---|
| neurodynamic testing | Other | – |
Primary outcome
mechanosensitivity of neural tissue in neurodynamic testing
Time frame: at enrolment
10 secondary outcomes
sensation thresholds for cold and warm temperatures in quantitative sensory testing
Time frame: at enrolment
pain thresholds for cold and warm temperatures in quantitative sensory testing
Time frame: at enrolment
vibration sensation threshold in quantitative sensory testing
Time frame: at enrolment
disability due to neck pain
Time frame: at enrolment
presence of neuropathic pain
Time frame: at enrolment
presence of anxiety
Time frame: at enrolment
presence of depression
Time frame: at enrolment
insomnia severity
Time frame: at enrolment
sleep quality
Time frame: at enrolment
presence of pain catastrophizing
Time frame: at enrolment
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 27 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Gunther Landmann study director
Swiss Paraplegic Centre
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 Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 27 Jan 2017. 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 Switzerland. 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?
mechanosensitivity of neural tissue in neurodynamic testing (time frame: at enrolment). 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 27 Jan 2017.