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Longitudinal Experimental Study on ULNTT and Cervico-Thoracic Spine Motion Patterns Relationship

Primary Purpose

Cervicobrachial Neuralgia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Spinal Manipulation
Sponsored by
University of Milano Bicocca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervicobrachial Neuralgia focused on measuring Neurodynamics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • AS group: ULNTT asymmetry >10°
  • S group: ULNTT symmetry

Exclusion Criteria:

  • History of neck, shoulder or arm surgical interventions or major trauma, peripheral neuropathy, mental disturbance, limitation of shoulder, elbow or wrist range of motion, BMI >25.

Sites / Locations

  • Istituti Clinici Zucchi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AS group

S group

Arm Description

Subjects with ULNTT asymmetry > 10°

Subjects with ULNTT symmetry

Outcomes

Primary Outcome Measures

Upper Limb Neural Tension Test at baseline: R2
ULNTT are neurodynamics test of brachial plexus. Two parameters are collected during the procedure: firm resistance to elbow extension, named R2, operator dependent, and severe pain onset, named P2, patient dependent. Both results are expressed as degrees that left to full elbow extension. Four repetition per side are performed and average value is calculated.
Upper Limb Neural Tension Test at baseline: P2
ULNTT are neurodynamics test of brachial plexus. Two parameters are collected during the procedure: firm resistance to elbow extension, named R2, operator dependent, and severe pain onset, named P2, patient dependent. Both results are expressed as degrees that left to full elbow extension. Four repetition per side are performed and average value is calculated.
Cervico-Thoracic Spine Lateral Bending at baseline
Cervico-thoracic spine side bending is registered with motion-capture technology. Results are analyzed with Least Square Approximation tools and expressed as mathematical parameters in angles. Four repetition per side are performed and average value is calculated.
Upper Limb Neural Tension Test after intervention: R2
ULNTT are neurodynamics test of brachial plexus. Two parameters are collected during the procedure: firm resistance to elbow extension, named R2, operator dependent, and severe pain onset, named P2, patient dependent. Both results are expressed as degrees that left to full elbow extension. Four repetition per side are performed and average value is calculated.
Upper Limb Neural Tension Test after intervention: P2
ULNTT are neurodynamics test of brachial plexus. Two parameters are collected during the procedure: firm resistance to elbow extension, named R2, operator dependent, and severe pain onset, named P2, patient dependent. Both results are expressed as degrees that left to full elbow extension. Four repetition per side are performed and average value is calculated.
Cervico-Thoracic Spine Lateral Bending after intervention
Cervico-thoracic spine side bending is registered with motion-capture technology. Results are analyzed with Least Square Approximation tools and expressed as mathematical parameters in angles. Four repetition per side are performed and average value is calculated.

Secondary Outcome Measures

Full Information

First Posted
December 3, 2015
Last Updated
February 28, 2016
Sponsor
University of Milano Bicocca
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1. Study Identification

Unique Protocol Identification Number
NCT02632357
Brief Title
Longitudinal Experimental Study on ULNTT and Cervico-Thoracic Spine Motion Patterns Relationship
Official Title
Longitudinal Experimental Study on ULNTT1 and Cervico-Thoracic Spine Motion Patterns Relationship
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milano Bicocca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study Design: Longitudinal Experimental Study Objective: Analyze the relationship between Upper Limb Neural Tension Test (ULNTT1) and cervico-thoracic spine biomechanics using a new motion-capture spine movement data analyzing model based on Least Square Approximation. Summary of Background Data: ULNTT1 is a test able to determine cervical nerve roots and brachial plexus displacement within their interface structures. No studies were conducted about ULNTT1 and cervico-thoracic spine motion patterns relationship. Methods: 12 subjects with ULNTT1 asymmetry > 10° (AS group) and 11 subjects with ULNTT1 symmetry (S group) at clinical tests will be enrolled for the study. Subjects will be analyzed for ULNTT1 with an electrogoniometer using two parameters, one operator and one patient-dependent. Fine lateral bending cervico-thoracic spine motion patterns will be collected with motion-capturing technique and data will be analyzed with Least Square Approximation tools. Subjects with impairments in cervico-thoracic spine mobility will undergo to correction of those with spinal manipulative therapy. ULNTT1 and spine mobility will be so re-evaluated with same methods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicobrachial Neuralgia
Keywords
Neurodynamics

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AS group
Arm Type
Experimental
Arm Description
Subjects with ULNTT asymmetry > 10°
Arm Title
S group
Arm Type
No Intervention
Arm Description
Subjects with ULNTT symmetry
Intervention Type
Other
Intervention Name(s)
Spinal Manipulation
Primary Outcome Measure Information:
Title
Upper Limb Neural Tension Test at baseline: R2
Description
ULNTT are neurodynamics test of brachial plexus. Two parameters are collected during the procedure: firm resistance to elbow extension, named R2, operator dependent, and severe pain onset, named P2, patient dependent. Both results are expressed as degrees that left to full elbow extension. Four repetition per side are performed and average value is calculated.
Time Frame
Baseline
Title
Upper Limb Neural Tension Test at baseline: P2
Description
ULNTT are neurodynamics test of brachial plexus. Two parameters are collected during the procedure: firm resistance to elbow extension, named R2, operator dependent, and severe pain onset, named P2, patient dependent. Both results are expressed as degrees that left to full elbow extension. Four repetition per side are performed and average value is calculated.
Time Frame
Baseline
Title
Cervico-Thoracic Spine Lateral Bending at baseline
Description
Cervico-thoracic spine side bending is registered with motion-capture technology. Results are analyzed with Least Square Approximation tools and expressed as mathematical parameters in angles. Four repetition per side are performed and average value is calculated.
Time Frame
Baseline
Title
Upper Limb Neural Tension Test after intervention: R2
Description
ULNTT are neurodynamics test of brachial plexus. Two parameters are collected during the procedure: firm resistance to elbow extension, named R2, operator dependent, and severe pain onset, named P2, patient dependent. Both results are expressed as degrees that left to full elbow extension. Four repetition per side are performed and average value is calculated.
Time Frame
Immediately after intervention, same day than baseline acquisition
Title
Upper Limb Neural Tension Test after intervention: P2
Description
ULNTT are neurodynamics test of brachial plexus. Two parameters are collected during the procedure: firm resistance to elbow extension, named R2, operator dependent, and severe pain onset, named P2, patient dependent. Both results are expressed as degrees that left to full elbow extension. Four repetition per side are performed and average value is calculated.
Time Frame
Immediately after intervention, same day than baseline acquisition
Title
Cervico-Thoracic Spine Lateral Bending after intervention
Description
Cervico-thoracic spine side bending is registered with motion-capture technology. Results are analyzed with Least Square Approximation tools and expressed as mathematical parameters in angles. Four repetition per side are performed and average value is calculated.
Time Frame
Immediately after intervention, same day than baseline acquisition

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: AS group: ULNTT asymmetry >10° S group: ULNTT symmetry Exclusion Criteria: History of neck, shoulder or arm surgical interventions or major trauma, peripheral neuropathy, mental disturbance, limitation of shoulder, elbow or wrist range of motion, BMI >25.
Facility Information:
Facility Name
Istituti Clinici Zucchi
City
Carate Brianza
State/Province
MB
ZIP/Postal Code
20841
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Longitudinal Experimental Study on ULNTT and Cervico-Thoracic Spine Motion Patterns Relationship

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