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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenandoah University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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