The Effect of Thoracic Spine Manipulation on Peripheral Neurodynamic Mobility

April 24, 2017 updated by: Aaron Hartstein, Shenandoah University

The Immediate Effects of Thoracic Spine Manipulation Versus a Sham Comparator on the Upper Limb Provocation Test and Seated Slump Test

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Shenandoah University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Spinal Manual Therapy
Supine thoracic spine manipulation located between the levels of T4-T7
Procedure: Spinal Manual Therapy
Other Names:
  • Active treatment group
Procedure: Spinal Range of Motion
Other Names:
  • Placebo/Sham group
SHAM_COMPARATOR: 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
Procedure: Spinal Manual Therapy
Other Names:
  • Active treatment group
Procedure: Spinal Range of Motion
Other Names:
  • Placebo/Sham group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper Limb Provocation Test Range of Motion Change (measured in degrees of elbow extension)
Time Frame: Pre and Immediately Post Intervention
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)
Time Frame: Pre and Immediately Post Intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Believability of Sham - measured via questionnaire
Time Frame: Immediately Post Intervention (after final measurements are read and recorded)
Subjects will be asked whether they believe they were in the active treatment group or the sham/placebo group after final measurements are taken.
Immediately Post Intervention (after final measurements are read and recorded)
Perceived effect - measured via questionnaire
Time Frame: Pre Intervention (immediately after initial measurements are recorded and prior to intervention)
Subjects will be asked whether they believe their upper and/or lower quarter mobility will change based on the group name they are assigned.
Pre Intervention (immediately after initial measurements are recorded and prior to intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenandoah University

Investigators

  • Study Director: Sheri A Hale, PhD, PT, ATC, Shenandoah University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (ESTIMATE)

July 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ShenandoahU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available to analyze; Subject grouping will not be available to participants in attempt to control believability of the sham comparator

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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