Somatosensory Phenotype of Patients Suffering From Unspecific Neck and Arm Pain

January 26, 2017 updated by: Swiss Paraplegic Centre Nottwil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Lucerne
      • Nottwil, Lucerne, Switzerland, 6207
        • Swiss Paraplegic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
neck disability index questionnaire
at enrolment
presence of neuropathic pain
Time Frame: at enrolment
neuropathic pain symptom inventory questionnaire
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
at enrolment
sleep quality
Time Frame: at enrolment
visual analogue scale
at enrolment
presence of pain catastrophizing
Time Frame: at enrolment
pain catastrophizing scale questionnaire
at enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Gunther Landmann, Swiss Paraplegic Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

December 7, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 14, 2015

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

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)?

No

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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