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Lumbar Thrust-mobilization Effects on Hip Strength and Anterior Knee Pain

Primary Purpose

Anterior Knee Pain Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lumbar-thrust mobilization
Sham thrust-mobilization
Sponsored by
Messiah College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Knee Pain Syndrome

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy males and females between the ages of 18 and 25 with non-traumatic anterior knee pain
  • Able read and write in English
  • Clearly understand the informed consent form

Exclusion Criteria:

  • Low back pain
  • Pregnant or may be pregnant
  • Previously diagnosed with spondylolisthesis,
  • Previously diagnosed with a herniated disc,
  • Signs and symptoms of nerve root compression
  • History of spine surgery
  • History of knee surgery
  • History of cancer
  • History of compression fracture
  • History of osteoporosis
  • History of osteopenia
  • History of a systemic disease
  • History of a connective tissue disease
  • History of a neurological disease
  • Pain with 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

    Lumbar thrust-mobilization

    Sham-mobilization

    Arm Description

    The investigator will perform a lumbar thrust-mobilization with the subject in right and then left sidelying position

    No lumbar-thrust mobilization will be performed. Subject will receive simple passive inter-vertebral range of motion.

    Outcomes

    Primary Outcome Measures

    Change in lateral hip strength
    lateral isometric hip strength will be measured with Biodex system 4
    Change in pain with single leg step down
    Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a single leg step down. The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.
    Change in pain with double leg squat
    Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a double leg squat. The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.
    Change in pain with drop jump from 2 foot platform
    Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a drop jump from a 2 foot platform. The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 1, 2019
    Last Updated
    October 7, 2019
    Sponsor
    Messiah College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04119310
    Brief Title
    Lumbar Thrust-mobilization Effects on Hip Strength and Anterior Knee Pain
    Official Title
    Lumbar Thrust-mobilization Effects on Hip Strength and Anterior Knee Pain, a Double Blind Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2019 (Anticipated)
    Primary Completion Date
    May 31, 2020 (Anticipated)
    Study Completion Date
    May 31, 2020 (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 investigate changes in lateral hip muscle strength as well as self-reported pain during the performance of three functional tests in patients with anterior knee pain following a lumbopelvic thrust-mobilization. Hypothesis(es): Lumbar thrust-mobilization will lead to increased lateral hip strength and decreased anterior knee pain during 3 functional activities (single leg step down, functional squat, drop jump).
    Detailed Description
    The participant will complete a medical history form and undergo a brief physical exam of the lumbar spine and knees to include: lumbar range of motion and mobility testing, knee range of motion, palpation, and knee mobility testing. The participant will complete a hip strength test utilizing the Biodex System 4 Pro®. The participant will then perform three activities (single leg step down, squat, and drop jump from a 2 foot platform) and provide a self-reported knee pain measure with each activity. 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. Th e participant will be positioned on a high-low treatment table to receive the assigned intervention. The participant will be positioned to receive 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 functional activities (single leg step down, squat, and drop jump from a 2 foot platform) while providing a self-reported pain measure after each activity. Follow-up measures at 15 minutes post-intervention and the final measure at 30 minutes post-intervention will be performed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anterior Knee Pain Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomly assigned to one of two interventions, thrust-mobilization or sham mobilization.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    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. The outcomes will be evaluated by a masked outcome assessor.
    Allocation
    Randomized
    Enrollment
    128 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Lumbar thrust-mobilization
    Arm Type
    Experimental
    Arm Description
    The investigator will perform a lumbar thrust-mobilization with the subject in right and then left sidelying position
    Arm Title
    Sham-mobilization
    Arm Type
    Sham Comparator
    Arm Description
    No lumbar-thrust mobilization will be performed. Subject will receive simple passive inter-vertebral range of motion.
    Intervention Type
    Other
    Intervention Name(s)
    Lumbar-thrust mobilization
    Other Intervention Name(s)
    Grade 5 mobilization, manipulation
    Intervention Description
    The intervention group will receive passive spinal rotational grade V thrust-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 thrust- mobilization while stabilizing the uppermost shoulder.
    Intervention Type
    Other
    Intervention Name(s)
    Sham thrust-mobilization
    Intervention Description
    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 passive range of motion 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 lateral hip strength
    Description
    lateral isometric hip strength will be measured with Biodex system 4
    Time Frame
    Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention
    Title
    Change in pain with single leg step down
    Description
    Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a single leg step down. The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.
    Time Frame
    Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention
    Title
    Change in pain with double leg squat
    Description
    Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a double leg squat. The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.
    Time Frame
    Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention
    Title
    Change in pain with drop jump from 2 foot platform
    Description
    Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a drop jump from a 2 foot platform. The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.
    Time Frame
    Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy males and females between the ages of 18 and 25 with non-traumatic anterior knee pain Able read and write in English Clearly understand the informed consent form Exclusion Criteria: Low back pain Pregnant or may be pregnant Previously diagnosed with spondylolisthesis, Previously diagnosed with a herniated disc, Signs and symptoms of nerve root compression History of spine surgery History of knee surgery History of cancer History of compression fracture History of osteoporosis History of osteopenia History of a systemic disease History of a connective tissue disease History of a neurological disease Pain with 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, PT, ScD
    Phone
    717-796-1800
    Ext
    3339
    Email
    kbergmann@messiah.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amy Humphrey, DPT
    Phone
    717-796-1800
    Ext
    3035
    Email
    ahumphrey@messiah.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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