Somatosensory Phenotype of Patients Suffering From Unspecific Neck and Arm Pain

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02629276
• Other study ID #: 2014-12
• Status: Completed
• Phase: N/A
• First received: December 7, 2015
• Last updated: January 26, 2017
• Start date: August 2014
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Furthermore, we determined whether there are any differences between groups in symptom severity, functional deficits, psychological parameters, quality of life and sleep.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• neurodynamic testing

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mechanosensitivity of neural tissue in neurodynamic testing		at enrolment
Secondary	sensation thresholds for cold and warm temperatures in quantitative sensory testing		at enrolment
Secondary	pain thresholds for cold and warm temperatures in quantitative sensory testing		at enrolment
Secondary	vibration sensation threshold in quantitative sensory testing		at enrolment
Secondary	disability due to neck pain	neck disability index questionnaire	at enrolment
Secondary	presence of neuropathic pain	neuropathic pain symptom inventory questionnaire	at enrolment
Secondary	presence of anxiety	hospital anxiety and depression scale questionnaire	at enrolment
Secondary	presence of depression	hospital anxiety and depression scale questionnaire	at enrolment
Secondary	insomnia severity	insomnia severity index questionnaire	at enrolment
Secondary	sleep quality	visual analogue scale	at enrolment
Secondary	presence of pain catastrophizing	pain catastrophizing scale questionnaire	at enrolment