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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04119310
Recruitment Status : Not yet recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Messiah College

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).


Condition or disease Intervention/treatment Phase
Anterior Knee Pain Syndrome Other: Lumbar-thrust mobilization Other: Sham thrust-mobilization Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to one of two interventions, thrust-mobilization or sham mobilization.
Masking: Triple (Participant, Investigator, Outcomes 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.

Primary Purpose: Treatment
Official Title: Lumbar Thrust-mobilization Effects on Hip Strength and Anterior Knee Pain, a Double Blind Randomized Control Trial
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Arm Intervention/treatment
Experimental: Lumbar thrust-mobilization
The investigator will perform a lumbar thrust-mobilization with the subject in right and then left sidelying position
Other: Lumbar-thrust mobilization
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.
Other Name: Grade 5 mobilization, manipulation

Sham Comparator: Sham-mobilization
No lumbar-thrust mobilization will be performed. Subject will receive simple passive inter-vertebral range of motion.
Other: Sham thrust-mobilization
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 Measures :
  1. Change in lateral hip strength [ Time Frame: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention ]
    lateral isometric hip strength will be measured with Biodex system 4

  2. Change in pain with single leg step down [ Time Frame: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention ]

    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.


  3. Change in pain with double leg squat [ Time Frame: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention ]

    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.


  4. Change in pain with drop jump from 2 foot platform [ Time Frame: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention ]

    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.




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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT04119310


Contacts
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Contact: Karl Bergmann, PT, ScD 717-796-1800 ext 3339 kbergmann@messiah.edu
Contact: Amy Humphrey, DPT 717-796-1800 ext 3035 ahumphrey@messiah.edu

Sponsors and Collaborators
Messiah College
Publications:

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Responsible Party: Messiah College
ClinicalTrials.gov Identifier: NCT04119310    
Other Study ID Numbers: BergmannHumphrey
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Patellofemoral Pain Syndrome
Joint Diseases
Musculoskeletal Diseases