Clinical trial NCT02842918: The Effect of Thoracic Spine Manipulation on Peripheral Neurodynamic Mobility
Official title: The Immediate Effects of Thoracic Spine Manipulation Versus a Sham Comparator on the Upper Limb Provocation Test and Seated Slump Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Manipulations
Keywords: Thoracic Spine Manipulation
Neurodynamics
Sham
Lead sponsor: Shenandoah University
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A convenience sample will be utilized to obtain subjects. Subjects will be given a brief questionnaire to identify possible contraindications for spinal treatment techniques and exclude individuals if necessary. Subjects will be randomized into one of two groups (spinal manual therapy or spinal range of motion which will serve as the name for the placebo group) and participate in neurodynamic testing procedures of the upper extremity (Upper Limb Provocation Testing) as well as lower extremity (Seated Slump Test). Subjects who are determined to be positive for one or more limbs will receive either a thoracic spine manipulation technique (spinal manual therapy) or a thoracic spine sham manipulation technique (spinal range of motion/placebo). After application of the technique, previously positive limbs will be retested. In attempt to determine validity and believability of the sham procedure and perception of its effect, subjects will be asked if they believe their upper/lower quarter mobility will change based on the group name and after the technique is applied. Subjects will also be asked if they believed they were in the treatment or placebo group.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Upper Limb Provocation Test Range of Motion Change (measured in degrees of elbow extension)
timeFrame: Pre and Immediately Post Intervention
measure: Seated Slump Test Range of Motion Change (measured in degrees of knee extension)
timeFrame: Pre and Immediately Post Intervention
Secondary outcomes:
measure: Believability of Sham - measured via questionnaire
timeFrame: Immediately Post Intervention (after final measurements are read and recorded)
measure: Perceived effect - measured via questionnaire
timeFrame: Pre Intervention (immediately after initial measurements are recorded and prior to intervention)
Other outcomes:
Locations:
city: Winchester
country: United States
facility: Shenandoah University
state: Virginia
Study officials:
affiliation: Shenandoah University
name: Sheri A Hale, PhD, PT, ATC
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Davis 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.
citation: Szlezak 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.
citation: Chu 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.
citation: Schmid 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.