Cervicobrachial NeuralgiaNCT02632357
Longitudinal Experimental Study on ULNTT and Cervico-Thoracic Spine Motion Patterns Relationship
A study testing Spinal Manipulation in people with Cervicobrachial Neuralgia, run by University of Milano Bicocca at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervicobrachial Neuralgia
- What is being tested?
- Spinal Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- AS group: ULNTT asymmetry >10°
- S group: ULNTT symmetry
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Experimental Study on ULNTT1 and Cervico-Thoracic Spine Motion Patterns Relationship
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.
Read more
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
- Being tested
- Spinal Manipulation
- Keywords
- Neurodynamics
- Medical subject headings
- Brachial Plexus Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal ManipulationOther
| Study group | Role | What they receive |
|---|---|---|
| AS group | Experimental | Subjects with ULNTT asymmetry > 10° Receives: Other: Spinal Manipulation |
| S group | No intervention | Subjects with ULNTT symmetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after intervention, same day than baseline acquisition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicobrachial NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Rossi, University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632357
- Sponsor's protocol ID
- UMilanoBicocca
- Status last verified
- Feb 2016
- First submitted
- 3 Dec 2015
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Experimental Study on ULNTT1 and Cervico-Thoracic Spine Motion Patterns Relationship
- ClinicalTrials.gov ID
- NCT02632357
- Acronym / sponsor ID
- UMilanoBicocca
- Conditions
- Cervicobrachial Neuralgia
- Keywords
- Neurodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AS group | Experimental | Other: Spinal ManipulationSubjects with ULNTT asymmetry > 10° |
| S group | No intervention | –Subjects with ULNTT symmetry |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- AS group: ULNTT asymmetry >10°
- S group: ULNTT symmetry
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Manipulation | Other | AS group |
Primary outcome
Upper Limb Neural Tension Test at baseline: R2
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: 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
Time frame: Immediately after intervention, same day than baseline acquisition
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
Time frame: Immediately after intervention, same day than baseline acquisition
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
Time frame: Immediately after intervention, same day than baseline acquisition
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Manipulation in people with Cervicobrachial Neuralgia, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Limb Neural Tension Test at baseline: R2 (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016.