NCT02629276

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 14, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

December 7, 2015

Last Update Submit

January 26, 2017

Conditions

Keywords

neck painarm painneurodynamic testsquantitative sensory testingsomatosensory profile

Outcome Measures

Primary Outcomes (1)

  • mechanosensitivity of neural tissue in neurodynamic testing

    at enrolment

Secondary Outcomes (10)

  • sensation thresholds for cold and warm temperatures in quantitative sensory testing

    at enrolment

  • pain thresholds for cold and warm temperatures in quantitative sensory testing

    at enrolment

  • vibration sensation threshold in quantitative sensory testing

    at enrolment

  • disability due to neck pain

    at enrolment

  • presence of neuropathic pain

    at enrolment

  • +5 more secondary outcomes

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • \- unilateral non specific neck-arm pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gunther Landmann

    Swiss Paraplegic Centre

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2015

First Posted

December 14, 2015

Study Start

August 1, 2014

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

January 27, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations