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

Cervicobrachial Neuralgia Clinical Trial

Official title:

Longitudinal Experimental Study on ULNTT1 and Cervico-Thoracic Spine Motion Patterns Relationship

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632357
• Other study ID #: UMilanoBicocca
• Status: Completed
• Phase: N/A
• First received: December 3, 2015
• Last updated: February 28, 2016
• Start date: December 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cervicobrachial Neuralgia

Intervention

Other:
• Spinal Manipulation

Locations

Country	Name	City	State
Italy	Istituti Clinici Zucchi	Carate Brianza	MB

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline	No
Primary	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.	Baseline	No
Primary	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.	Baseline	No
Primary	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.	Immediately after intervention, same day than baseline acquisition	No
Primary	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.	Immediately after intervention, same day than baseline acquisition	No
Primary	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.	Immediately after intervention, same day than baseline acquisition	No