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OpenTrials
Completed

NCT Number: NCT02629276

Somatosensory Phenotype of Patients Suffering From Unspecific Neck and Arm Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neurodynamic testing

Other

Primary outcomes

  1. mechanosensitivity of neural tissue in neurodynamic testing

    Time frame: at enrolment

Secondary outcomes

  1. sensation thresholds for cold and warm temperatures in quantitative sensory testing

    Time frame: at enrolment

  2. pain thresholds for cold and warm temperatures in quantitative sensory testing

    Time frame: at enrolment

  3. vibration sensation threshold in quantitative sensory testing

    Time frame: at enrolment

  4. disability due to neck pain

    Time frame: at enrolment

    neck disability index questionnaire

  5. presence of neuropathic pain

    Time frame: at enrolment

    neuropathic pain symptom inventory questionnaire

  6. presence of anxiety

    Time frame: at enrolment

    hospital anxiety and depression scale questionnaire

  7. presence of depression

    Time frame: at enrolment

    hospital anxiety and depression scale questionnaire

  8. insomnia severity

    Time frame: at enrolment

    insomnia severity index questionnaire

  9. sleep quality

    Time frame: at enrolment

    visual analogue scale

  10. presence of pain catastrophizing

    Time frame: at enrolment

    pain catastrophizing scale questionnaire

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study title

Somatosensory Profiles in Patients With Non Specific Neck Arm Pain With and Without Positive Neurodynamic Tests

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 14, 2015
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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