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Completed

NCT Number: NCT02842918

The Effect of Thoracic Spine Manipulation on Peripheral Neurodynamic Mobility

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shenandoah University

Winchester, Virginia, 22601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal Manual Therapy

Procedure

Other names: Active treatment group

Spinal Range of Motion

Procedure

Other names: Placebo/Sham group

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Shenandoah University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jul 25, 2016
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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