The Effect of Thoracic Spine Manipulation on Peripheral Neurodynamic Mobility
The Immediate Effects of Thoracic Spine Manipulation Versus a Sham Comparator on the Upper Limb Provocation Test and Seated Slump Test
1 other identifier
interventional
43
1 country
1
Brief Summary
No studies have investigated the effects of a supine thoracic spine manipulation (TSM) on neurodynamic mobility, as compared to a sham intervention. This study aims to determine the immediate effects of TSM on the Upper Limb Provocation Test (ULPT) and Seated Slump Test (SST) compared to a sham intervention in asymptomatic subjects with neurodynamic limitations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 19, 2016
CompletedFirst Posted
Study publicly available on registry
July 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedApril 25, 2017
April 1, 2017
10 months
July 19, 2016
April 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Upper Limb Provocation Test Range of Motion Change (measured in degrees of elbow extension)
Subjects will lie on their back with their shoulder slightly off the edge of a treatment table. The investigator will then bend the subjects neck away from the shoulder being tested and position the arm into the starting test position. The investigator will then straighten the subjects elbow until it is fully extended, or until the subject reports discomfort or an abnormal feeling in their arm. This procedure will be completed before and immediately after either the treatment intervention (manipulation) or the sham intervention is completed.
Pre and Immediately Post Intervention
Seated Slump Test Range of Motion Change (measured in degrees of knee extension)
Subjects will sit at the edge of treatment table. Subjects will be asked to flex then neck towards their chest. The investigator will then apply a gentle force to their upper back and will ask the subject to remain in this position. The investigator will move the subjects foot upwards and straighten their leg until it is fully extended or until the subject reports discomfort or an abnormal feeling in their leg.This procedure will be completed before and immediately after either the treatment intervention (manipulation) or the sham intervention is completed.
Pre and Immediately Post Intervention
Secondary Outcomes (2)
Believability of Sham - measured via questionnaire
Immediately Post Intervention (after final measurements are read and recorded)
Perceived effect - measured via questionnaire
Pre Intervention (immediately after initial measurements are recorded and prior to intervention)
Study Arms (2)
Spinal Manual Therapy
ACTIVE COMPARATORSupine thoracic spine manipulation located between the levels of T4-T7
Spinal Range of Motion
SHAM COMPARATORSupine thoracic spine sham manipulation located between the levels of T4-T7; identical procedure as the active treatment intervention but without the delivery of high velocity low amplitude thrust
Interventions
Eligibility Criteria
You may qualify if:
- Upper Limb Provocation Test results with limitation of greater than 60 deg of elbow extension at the time of measurement
- Seated Slump Test results with limitation of greater than 22 deg of knee extension at the time of measurement
You may not qualify if:
- History of cervical or lumbar pain requiring medical intervention within the last two years, history of upper or lower extremity paresthesia/numbness, self reported bone density disorders, previous spinal cord injury, diagnosed intervertebral disc herniation, previous diagnosis of spinal stenosis or disc pathology, current pregnancy, history of circulatory or neurological disorders, history of spine and extremity fractures or dislocations in the last two years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shenandoah University
Winchester, Virginia, 22601, United States
Related Publications (5)
Michener LA, Kardouni JR, Sousa CO, Ely JM. Validation of a sham comparator for thoracic spinal manipulation in patients with shoulder pain. Man Ther. 2015 Feb;20(1):171-5. doi: 10.1016/j.math.2014.08.008. Epub 2014 Sep 6.
PMID: 25261090RESULTDavis DS, Anderson IB, Carson MG, Elkins CL, Stuckey LB. Upper Limb Neural Tension and Seated Slump Tests: The False Positive Rate among Healthy Young Adults without Cervical or Lumbar Symptoms. J Man Manip Ther. 2008;16(3):136-41. doi: 10.1179/jmt.2008.16.3.136.
PMID: 19119402RESULTSzlezak AM, Georgilopoulos P, Bullock-Saxton JE, Steele MC. The immediate effect of unilateral lumbar Z-joint mobilisation on posterior chain neurodynamics: a randomised controlled study. Man Ther. 2011 Dec;16(6):609-13. doi: 10.1016/j.math.2011.06.004. Epub 2011 Jul 13.
PMID: 21742541RESULTChu J, Allen DD, Pawlowsky S, Smoot B. Peripheral response to cervical or thoracic spinal manual therapy: an evidence-based review with meta analysis. J Man Manip Ther. 2014 Nov;22(4):220-9. doi: 10.1179/2042618613Y.0000000062.
PMID: 25395830RESULTSchmid A, Brunner F, Wright A, Bachmann LM. Paradigm shift in manual therapy? Evidence for a central nervous system component in the response to passive cervical joint mobilisation. Man Ther. 2008 Oct;13(5):387-96. doi: 10.1016/j.math.2007.12.007. Epub 2008 Mar 3.
PMID: 18316238RESULT
Study Officials
- STUDY DIRECTOR
Sheri A Hale, PhD, PT, ATC
Shenandoah University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor Division of Physical Therapy
Study Record Dates
First Submitted
July 19, 2016
First Posted
July 25, 2016
Study Start
February 1, 2016
Primary Completion
December 1, 2016
Study Completion
February 1, 2017
Last Updated
April 25, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will share
Data will be available to analyze; Subject grouping will not be available to participants in attempt to control believability of the sham comparator