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The Effect of Spinal Manipulation on Hip Extension Strength and Jump Height

Primary Purpose

Weakness, Muscle

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lumbar manipulation
Sham Manipulation
Sponsored by
Messiah College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Weakness, Muscle

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Between the ages of 18 and 30 able to read and write in English and clearly understand the informed consent. Exclusion Criteria: currently have low back pain pregnant or may be pregnant previously diagnosed with spondylolisthesis, a herniated disc, or have signs and symptoms of nerve root compression history of spine surgery history of cancer, compression fracture, osteoporosis, osteopenia, or a history of systemic, connective tissue, or neurological disease, pain with the pre-manipulative hold positive findings on medical history form, or physical exam, presence of anxiety during the procedure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Manipulation

    Sham Manipulation

    Arm Description

    Left and right sidelyiing gaping high velocity low amplitude thrust mobilization

    The experimenter holds both knees with one arm while placing their opposite hand on the participant's lumbar spine. The experimenter performs 1 min of flexion and extension PROM without reaching physiological end range in either direction of movement. This is repeated with the subject in left sidelying.

    Outcomes

    Primary Outcome Measures

    Change in hip extension strength
    microFET 2 Manual Muscle Tester Hand Held Dynamometer

    Secondary Outcome Measures

    Change in jump height
    Just Jump System

    Full Information

    First Posted
    October 3, 2022
    Last Updated
    January 10, 2023
    Sponsor
    Messiah College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05689723
    Brief Title
    The Effect of Spinal Manipulation on Hip Extension Strength and Jump Height
    Official Title
    The Effect of Spinal Manipulation on Hip Extension Strength and Jump Height, A Double Blind Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    October 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Messiah College

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to study the effects of lumbar manipulation on hip extension strength and jump height in healthy subjects. Procedures to be followed: First, the subject will be asked to complete a medical history form. Then they will be instructed on the procedure for strength and jump testing. Next, range of motion of the low back will be measured. Then hip strength will be measured using a digital handheld measurement tool. The subject will then be asked to jump as high as they can on a floor mat. The subject will then receive a sealed envelope indicating the intervention they will to receive, either the manipulation or a fake manipulation. Instructions will be provided, and the subject will be positioned on a treatment table to receive the intervention. At this point, they will either receive the manipulation or fake manipulation on the right and left side. An immediate re-test of hip strength will be taken, and the subject will again jump as high as they can on a floor mat. Follow-up measures of these tests will be completed again 20 minutes after the intervention is given.
    Detailed Description
    The participant will complete a medical history form and undergo a brief active range of motion screen of the lumbar spine. The participant will complete a hip strength test utilizing the microFET 2 Manual Muscle Tester Hand Held Dynamometer. The participant will then jump as high as they can on the Just Jump System. A sealed envelope indicating the intervention to be received will be given to the participant. An investigator blinded to the pre and post-measures will open the envelope indicating the intervention to be performed. The participant will be blinded to which intervention group they are categorized to. The participant will be positioned on a high-low treatment table to receive the assigned intervention, either intervention 1 (thrust mobilization) or 2 (sham mobilization). The participant will either receive the thrust-mobilization or sham mobilization up to 2 times on the left and right side. An immediate re-test of hip strength will be conducted followed by performing the same three jumps. Follow-up measures at 20 minutes post-intervention will be performed. Intervention for the Thrust-mobilization Group The intervention group will receive passive spinal rotational grade V mobilization, based on Maitland's approach. The intervention will be performed with the subject in right sidelying and left sidelying. The operator's palpating hand is placed over the L2-3 intervertebral space, and the other hand bends both legs of the participant up to the range at which the L2-3 midposition is found. The participant is then asked to straighten the lower leg and hook the upper leg over it with the upper leg's knee positioned over the side of the plinth. While the lower component is kept still, the participant's trunk is rotated until the hip starts to lift off from the plinth. The bottom hand and uppermost hand rest under a pillow and the chest wall, respectively. With the starting position settled, the operator stands behind the participant, takes up the slack within the spine and then provides a grade V mobilization while stabilizing the uppermost shoulder. Intervention for the Sham Group Subjects are positioned in right sidelying. The experimenter holds both knees with one arm while placing their opposite hand on the participant's lumbar spine. The experimenter performs 1 min of flexion and extension PROM without reaching physiological end range in either direction of movement. This is repeated with the subject in left sidelying. Double Blind: The subjects will not know what intervention they are receiving - same generic script is provided. One Investigator is performing all pre and post-tests without knowledge of intervention, the other investigator is opening the envelope and providing the intervention behind a screen without knowledge of test results. This investigator will record the subjects assigned # and which intervention they received. Investigators will record data on spreadsheet separately.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weakness, Muscle

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Manipulation
    Arm Type
    Experimental
    Arm Description
    Left and right sidelyiing gaping high velocity low amplitude thrust mobilization
    Arm Title
    Sham Manipulation
    Arm Type
    Sham Comparator
    Arm Description
    The experimenter holds both knees with one arm while placing their opposite hand on the participant's lumbar spine. The experimenter performs 1 min of flexion and extension PROM without reaching physiological end range in either direction of movement. This is repeated with the subject in left sidelying.
    Intervention Type
    Procedure
    Intervention Name(s)
    Lumbar manipulation
    Intervention Description
    Left and right sidelyiing gaping high velocity low amplitude thrust mobilization
    Intervention Type
    Procedure
    Intervention Name(s)
    Sham Manipulation
    Intervention Description
    The experimenter holds both knees with one arm while placing their opposite hand on the participant's lumbar spine. The experimenter performs 1 min of flexion and extension PROM without reaching physiological end range in either direction of movement. This is repeated with the subject in left sidelying.
    Primary Outcome Measure Information:
    Title
    Change in hip extension strength
    Description
    microFET 2 Manual Muscle Tester Hand Held Dynamometer
    Time Frame
    immediately post instervention and 20 minutes post
    Secondary Outcome Measure Information:
    Title
    Change in jump height
    Description
    Just Jump System
    Time Frame
    immediately post instervention and 20 minutes post

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Between the ages of 18 and 30 able to read and write in English and clearly understand the informed consent. Exclusion Criteria: currently have low back pain pregnant or may be pregnant previously diagnosed with spondylolisthesis, a herniated disc, or have signs and symptoms of nerve root compression history of spine surgery history of cancer, compression fracture, osteoporosis, osteopenia, or a history of systemic, connective tissue, or neurological disease, pain with the pre-manipulative hold positive findings on medical history form, or physical exam, presence of anxiety during the procedure
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Karl Bergmann, ScD
    Phone
    717-796-1800
    Ext
    3339
    Email
    kbergmann@messiah.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amy Humphrey, PhD(c)
    Phone
    717-796-1800
    Ext
    3035
    Email
    ahumphrey@messiah.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    24421619
    Citation
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    Citation
    Wainner RS, Whitman JM, Cleland JA, Flynn TW. Regional interdependence: a musculoskeletal examination model whose time has come. J Orthop Sports Phys Ther. 2007 Nov;37(11):658-60. doi: 10.2519/jospt.2007.0110. No abstract available.
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    27477473
    Citation
    Mintken PE, McDevitt AW, Cleland JA, Boyles RE, Beardslee AR, Burns SA, Haberl MD, Hinrichs LA, Michener LA. Cervicothoracic Manual Therapy Plus Exercise Therapy Versus Exercise Therapy Alone in the Management of Individuals With Shoulder Pain: A Multicenter Randomized Controlled Trial. J Orthop Sports Phys Ther. 2016 Aug;46(8):617-28. doi: 10.2519/jospt.2016.6319.
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    Citation
    McDevitt A, Young J, Mintken P, Cleland J. Regional interdependence and manual therapy directed at the thoracic spine. J Man Manip Ther. 2015 Jul;23(3):139-46. doi: 10.1179/2042618615Y.0000000005.
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    Citation
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