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Trial record 25 of 248 for:    test AND provocation

The Effect of Thoracic Spine Manipulation on Peripheral Neurodynamic Mobility

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ClinicalTrials.gov Identifier: NCT02842918
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Aaron Hartstein, Shenandoah University

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.

Condition or disease Intervention/treatment Phase
Musculoskeletal Manipulations Procedure: Spinal Manual Therapy Procedure: Spinal Range of Motion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Immediate Effects of Thoracic Spine Manipulation Versus a Sham Comparator on the Upper Limb Provocation Test and Seated Slump Test
Study Start Date : February 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Active Comparator: Spinal Manual Therapy
Supine thoracic spine manipulation located between the levels of T4-T7
Procedure: Spinal Manual Therapy
Other Name: Active treatment group

Procedure: Spinal Range of Motion
Other Name: 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 Name: Active treatment group

Procedure: Spinal Range of Motion
Other Name: Placebo/Sham group




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842918


Locations
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United States, Virginia
Shenandoah University
Winchester, Virginia, United States, 22601
Sponsors and Collaborators
Shenandoah University
Investigators
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Study Director: Sheri A Hale, PhD, PT, ATC Shenandoah University

Publications of Results:
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Responsible Party: Aaron Hartstein, Assistant Professor Division of Physical Therapy, Shenandoah University
ClinicalTrials.gov Identifier: NCT02842918     History of Changes
Other Study ID Numbers: ShenandoahU
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Keywords provided by Aaron Hartstein, Shenandoah University:
Thoracic Spine Manipulation
Neurodynamics
Sham