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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Switzerland

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.

  1. mechanosensitivity of neural tissue in neurodynamic testing

    Measured: at enrolment

Secondary outcomes (10)
  1. sensation thresholds for cold and warm temperatures in quantitative sensory testing

    Measured: at enrolment

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

    Measured: at enrolment

  3. vibration sensation threshold in quantitative sensory testing

    Measured: at enrolment

  4. disability due to neck pain

    neck disability index questionnaire

    Measured: at enrolment

  5. presence of neuropathic pain

    neuropathic pain symptom inventory questionnaire

    Measured: at enrolment

  6. presence of anxiety

    hospital anxiety and depression scale questionnaire

    Measured: at enrolment

  7. presence of depression

    hospital anxiety and depression scale questionnaire

    Measured: at enrolment

  8. insomnia severity

    insomnia severity index questionnaire

    Measured: at enrolment

  9. sleep quality

    visual analogue scale

    Measured: at enrolment

  10. 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.

  1. First posted14 Dec 2015 (estimated)
  2. Study startAug 2014
  3. Primary completionDec 2016
  4. Study completionJan 2017

Resources

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)
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

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.

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