NCT04119310

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

October 1, 2019

Last Update Submit

October 7, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in lateral hip strength

    lateral isometric hip strength will be measured with Biodex system 4

    Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention

  • 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.

    Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention

  • 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.

    Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention

  • 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.

    Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention

Study Arms (2)

Lumbar thrust-mobilization

EXPERIMENTAL

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

Other: Lumbar-thrust mobilization

Sham-mobilization

SHAM COMPARATOR

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

Other: Sham thrust-mobilization

Interventions

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.

Also known as: Grade 5 mobilization, manipulation
Lumbar 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.

Sham-mobilization

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (31)

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    PMID: 17154139BACKGROUND
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    PMID: 17549951BACKGROUND
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    PMID: 12098160BACKGROUND
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    PMID: 23456237BACKGROUND
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    PMID: 17263214BACKGROUND
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    PMID: 23016077BACKGROUND
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    PMID: 18582383BACKGROUND
  • Witvrouw E, Lysens R, Bellemans J, Cambier D, Vanderstraeten G. Intrinsic risk factors for the development of anterior knee pain in an athletic population. A two-year prospective study. Am J Sports Med. 2000 Jul-Aug;28(4):480-9. doi: 10.1177/03635465000280040701.

    PMID: 10921638BACKGROUND
  • Powers CM. Rehabilitation of patellofemoral joint disorders: a critical review. J Orthop Sports Phys Ther. 1998 Nov;28(5):345-54. doi: 10.2519/jospt.1998.28.5.345.

    PMID: 9809282BACKGROUND
  • Crossley K, Bennell K, Green S, McConnell J. A systematic review of physical interventions for patellofemoral pain syndrome. Clin J Sport Med. 2001 Apr;11(2):103-10. doi: 10.1097/00042752-200104000-00007.

    PMID: 11403109BACKGROUND
  • Lake DA, Wofford NH. Effect of therapeutic modalities on patients with patellofemoral pain syndrome: a systematic review. Sports Health. 2011 Mar;3(2):182-9. doi: 10.1177/1941738111398583.

    PMID: 23016007BACKGROUND
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    PMID: 12435653BACKGROUND
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    PMID: 16365375BACKGROUND
  • Lowry CD, Cleland JA, Dyke K. Management of patients with patellofemoral pain syndrome using a multimodal approach: a case series. J Orthop Sports Phys Ther. 2008 Nov;38(11):691-702. doi: 10.2519/jospt.2008.2690.

    PMID: 18978450BACKGROUND
  • Mascal CL, Landel R, Powers C. Management of patellofemoral pain targeting hip, pelvis, and trunk muscle function: 2 case reports. J Orthop Sports Phys Ther. 2003 Nov;33(11):647-60. doi: 10.2519/jospt.2003.33.11.647.

    PMID: 14669960BACKGROUND
  • Fukuda TY, Rossetto FM, Magalhaes E, Bryk FF, Lucareli PR, de Almeida Aparecida Carvalho N. Short-term effects of hip abductors and lateral rotators strengthening in females with patellofemoral pain syndrome: a randomized controlled clinical trial. J Orthop Sports Phys Ther. 2010 Nov;40(11):736-42. doi: 10.2519/jospt.2010.3246.

    PMID: 21041965BACKGROUND
  • Pickar JG. Neurophysiological effects of spinal manipulation. Spine J. 2002 Sep-Oct;2(5):357-71. doi: 10.1016/s1529-9430(02)00400-x.

    PMID: 14589467BACKGROUND
  • Espi-Lopez GV, Arnal-Gomez A, Balasch-Bernat M, Ingles M. Effectiveness of Manual Therapy Combined With Physical Therapy in Treatment of Patellofemoral Pain Syndrome: Systematic Review. J Chiropr Med. 2017 Jun;16(2):139-146. doi: 10.1016/j.jcm.2016.10.003. Epub 2016 Nov 22.

    PMID: 28559754BACKGROUND
  • Grindstaff TL, Hertel J, Beazell JR, Magrum EM, Kerrigan DC, Fan X, Ingersoll CD. Lumbopelvic joint manipulation and quadriceps activation of people with patellofemoral pain syndrome. J Athl Train. 2012 Jan-Feb;47(1):24-31. doi: 10.4085/1062-6050-47.1.24.

    PMID: 22488227BACKGROUND
  • Grindstaff TL, Hertel J, Beazell JR, Magrum EM, Ingersoll CD. Effects of lumbopelvic joint manipulation on quadriceps activation and strength in healthy individuals. Man Ther. 2009 Aug;14(4):415-20. doi: 10.1016/j.math.2008.06.005. Epub 2008 Sep 20.

    PMID: 18805726BACKGROUND
  • Sanders GD, Nitz AJ, Abel MG, Symons TB, Shapiro R, Black WS, Yates JW. Effects of Lumbosacral Manipulation on Isokinetic Strength of the Knee Extensors and Flexors in Healthy Subjects: A Randomized, Controlled, Single-Blind Crossover Trial. J Chiropr Med. 2015 Dec;14(4):240-8. doi: 10.1016/j.jcm.2015.08.002. Epub 2015 Nov 6.

    PMID: 26793035BACKGROUND
  • Yuen TS, Lam PY, Lau MY, Siu WL, Yu KM, Lo CN, Ng J. Changes in Lower Limb Strength and Function Following Lumbar Spinal Mobilization. J Manipulative Physiol Ther. 2017 Oct;40(8):587-596. doi: 10.1016/j.jmpt.2017.07.003.

    PMID: 29187310BACKGROUND
  • Hillermann B, Gomes AN, Korporaal C, Jackson D. A pilot study comparing the effects of spinal manipulative therapy with those of extra-spinal manipulative therapy on quadriceps muscle strength. J Manipulative Physiol Ther. 2006 Feb;29(2):145-9. doi: 10.1016/j.jmpt.2005.12.003.

    PMID: 16461174BACKGROUND
  • Suter E, McMorland G, Herzog W, Bray R. Conservative lower back treatment reduces inhibition in knee-extensor muscles: a randomized controlled trial. J Manipulative Physiol Ther. 2000 Feb;23(2):76-80.

    PMID: 10714531BACKGROUND
  • Suter E, McMorland G, Herzog W, Bray R. Decrease in quadriceps inhibition after sacroiliac joint manipulation in patients with anterior knee pain. J Manipulative Physiol Ther. 1999 Mar-Apr;22(3):149-53. doi: 10.1016/S0161-4754(99)70128-4.

    PMID: 10220713BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Central Study Contacts

Karl Bergmann, PT, ScD

CONTACT

Amy Humphrey, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two interventions, thrust-mobilization or sham mobilization.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 8, 2019

Study Start

November 1, 2019

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

October 8, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share