NCT02842918

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

July 19, 2016

Last Update Submit

April 24, 2017

Conditions

Keywords

Thoracic Spine ManipulationNeurodynamicsSham

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 COMPARATOR

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

Procedure: Spinal Manual TherapyProcedure: Spinal Range of Motion

Spinal Range of Motion

SHAM COMPARATOR

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

Procedure: Spinal Manual TherapyProcedure: Spinal Range of Motion

Interventions

Also known as: Active treatment group
Spinal Manual TherapySpinal Range of Motion
Also known as: Placebo/Sham group
Spinal Manual TherapySpinal Range of Motion

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Officials

  • Sheri A Hale, PhD, PT, ATC

    Shenandoah University

    STUDY DIRECTOR

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

Locations