- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02629276
Somatosensory Phenotype of Patients Suffering From Unspecific Neck and Arm Pain
Somatosensory Profiles in Patients With Non Specific Neck Arm Pain With and Without Positive Neurodynamic Tests
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lucerne
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Nottwil, Lucerne, Switzerland, 6207
- Swiss Paraplegic Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- unilateral non specific neck-arm pain
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mechanosensitivity of neural tissue in neurodynamic testing
Time Frame: at enrolment
|
at enrolment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sensation thresholds for cold and warm temperatures in quantitative sensory testing
Time Frame: at enrolment
|
at enrolment
|
|
pain thresholds for cold and warm temperatures in quantitative sensory testing
Time Frame: at enrolment
|
at enrolment
|
|
vibration sensation threshold in quantitative sensory testing
Time Frame: at enrolment
|
at enrolment
|
|
disability due to neck pain
Time Frame: at enrolment
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neck disability index questionnaire
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at enrolment
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presence of neuropathic pain
Time Frame: at enrolment
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neuropathic pain symptom inventory questionnaire
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at enrolment
|
presence of anxiety
Time Frame: at enrolment
|
hospital anxiety and depression scale questionnaire
|
at enrolment
|
presence of depression
Time Frame: at enrolment
|
hospital anxiety and depression scale questionnaire
|
at enrolment
|
insomnia severity
Time Frame: at enrolment
|
insomnia severity index questionnaire
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at enrolment
|
sleep quality
Time Frame: at enrolment
|
visual analogue scale
|
at enrolment
|
presence of pain catastrophizing
Time Frame: at enrolment
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pain catastrophizing scale questionnaire
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at enrolment
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gunther Landmann, Swiss Paraplegic Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-12 (Other Identifier: AP HM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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