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

NCT02632357 | Completed DMC

• 1 other identifier: UMilanoBicocca
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervicobrachial Neuralgia

Keywords

Neurodynamics

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

AS group

EXPERIMENTAL

Subjects with ULNTT asymmetry \> 10°

Other: Spinal Manipulation

S group

NO INTERVENTION

Subjects with ULNTT symmetry

Interventions

Spinal Manipulation OTHER

AS group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

Istituti Clinici Zucchi

Carate Brianza, MB, 20841, Italy

Location

MeSH Terms

Conditions

Brachial Plexus Neuritis

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Brachial Plexus Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuritis

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 16, 2015
• Study Start: December 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 1, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)