The Effect of Thoracic Spine Manipulation on Peripheral Neurodynamic Mobility

NCT ID: NCT02842918

Last Updated: 2017-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Musculoskeletal Manipulations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Spinal Manual Therapy

Supine thoracic spine manipulation located between the levels of T4-T7

Group Type ACTIVE_COMPARATOR

Spinal Manual Therapy

Intervention Type PROCEDURE

Spinal Range of Motion

Intervention Type PROCEDURE

Spinal Range of Motion

Supine 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

Group Type SHAM_COMPARATOR

Spinal Manual Therapy

Intervention Type PROCEDURE

Spinal Range of Motion

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spinal Manual Therapy

Intervention Type PROCEDURE

Spinal Range of Motion

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Active treatment group Placebo/Sham group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shenandoah University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aaron Hartstein

Assistant Professor Division of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sheri A Hale, PhD, PT, ATC

Role: STUDY_DIRECTOR

Shenandoah University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shenandoah University

Winchester, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 25261090 (View on PubMed)

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.

Reference Type RESULT
PMID: 19119402 (View on PubMed)

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.

Reference Type RESULT
PMID: 21742541 (View on PubMed)

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.

Reference Type RESULT
PMID: 25395830 (View on PubMed)

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.

Reference Type RESULT
PMID: 18316238 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ShenandoahU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.