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
About this trial
This is an interventional treatment trial for Anterior Knee Pain Syndrome
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
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
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
Citations:
PubMed Identifier
29392329
Citation
Saltychev M, Dutton RA, Laimi K, Beaupre GS, Virolainen P, Fredericson M. Effectiveness of conservative treatment for patellofemoral pain syndrome: A systematic review and meta-analysis. J Rehabil Med. 2018 May 8;50(5):393-401. doi: 10.2340/16501977-2295.
Results Reference
background
PubMed Identifier
12570282
Citation
Bizzini M, Childs JD, Piva SR, Delitto A. Systematic review of the quality of randomized controlled trials for patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2003 Jan;33(1):4-20. doi: 10.2519/jospt.2003.33.1.4.
Results Reference
background
PubMed Identifier
20118526
Citation
Powers CM. The influence of abnormal hip mechanics on knee injury: a biomechanical perspective. J Orthop Sports Phys Ther. 2010 Feb;40(2):42-51. doi: 10.2519/jospt.2010.3337.
Results Reference
background
PubMed Identifier
18515959
Citation
Iverson CA, Sutlive TG, Crowell MS, Morrell RL, Perkins MW, Garber MB, Moore JH, Wainner RS. Lumbopelvic manipulation for the treatment of patients with patellofemoral pain syndrome: development of a clinical prediction rule. J Orthop Sports Phys Ther. 2008 Jun;38(6):297-309; discussion 309-12. doi: 10.2519/jospt.2008.2669. Epub 2008 Jan 22.
Results Reference
background
PubMed Identifier
14992676
Citation
Sutlive TG, Mitchell SD, Maxfield SN, McLean CL, Neumann JC, Swiecki CR, Hall RC, Bare AC, Flynn TW. Identification of individuals with patellofemoral pain whose symptoms improved after a combined program of foot orthosis use and modified activity: a preliminary investigation. Phys Ther. 2004 Jan;84(1):49-61.
Results Reference
background
PubMed Identifier
19765240
Citation
Boling M, Padua D, Marshall S, Guskiewicz K, Pyne S, Beutler A. Gender differences in the incidence and prevalence of patellofemoral pain syndrome. Scand J Med Sci Sports. 2010 Oct;20(5):725-30. doi: 10.1111/j.1600-0838.2009.00996.x.
Results Reference
background
PubMed Identifier
17154139
Citation
Lesher JD, Sutlive TG, Miller GA, Chine NJ, Garber MB, Wainner RS. Development of a clinical prediction rule for classifying patients with patellofemoral pain syndrome who respond to patellar taping. J Orthop Sports Phys Ther. 2006 Nov;36(11):854-66. doi: 10.2519/jospt.2006.2208.
Results Reference
background
PubMed Identifier
17549951
Citation
Robinson RL, Nee RJ. Analysis of hip strength in females seeking physical therapy treatment for unilateral patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2007 May;37(5):232-8. doi: 10.2519/jospt.2007.2439.
Results Reference
background
PubMed Identifier
12098160
Citation
Cowan SM, Hodges PW, Bennell KL, Crossley KM. Altered vastii recruitment when people with patellofemoral pain syndrome complete a postural task. Arch Phys Med Rehabil. 2002 Jul;83(7):989-95. doi: 10.1053/apmr.2002.33234.
Results Reference
background
PubMed Identifier
23456237
Citation
McCarthy MM, Strickland SM. Patellofemoral pain: an update on diagnostic and treatment options. Curr Rev Musculoskelet Med. 2013 Jun;6(2):188-94. doi: 10.1007/s12178-013-9159-x.
Results Reference
background
PubMed Identifier
17263214
Citation
Dixit S, DiFiori JP, Burton M, Mines B. Management of patellofemoral pain syndrome. Am Fam Physician. 2007 Jan 15;75(2):194-202.
Results Reference
background
PubMed Identifier
23016077
Citation
Pappas E, Wong-Tom WM. Prospective Predictors of Patellofemoral Pain Syndrome: A Systematic Review With Meta-analysis. Sports Health. 2012 Mar;4(2):115-20. doi: 10.1177/1941738111432097.
Results Reference
background
PubMed Identifier
18582383
Citation
Waryasz GR, McDermott AY. Patellofemoral pain syndrome (PFPS): a systematic review of anatomy and potential risk factors. Dyn Med. 2008 Jun 26;7:9. doi: 10.1186/1476-5918-7-9.
Results Reference
background
PubMed Identifier
10921638
Citation
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.
Results Reference
background
PubMed Identifier
9809282
Citation
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.
Results Reference
background
PubMed Identifier
11403109
Citation
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.
Results Reference
background
PubMed Identifier
23016007
Citation
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.
Results Reference
background
PubMed Identifier
12435653
Citation
Crossley K, Bennell K, Green S, Cowan S, McConnell J. Physical therapy for patellofemoral pain: a randomized, double-blinded, placebo-controlled trial. Am J Sports Med. 2002 Nov-Dec;30(6):857-65. doi: 10.1177/03635465020300061701.
Results Reference
background
PubMed Identifier
16365375
Citation
Tyler TF, Nicholas SJ, Mullaney MJ, McHugh MP. The role of hip muscle function in the treatment of patellofemoral pain syndrome. Am J Sports Med. 2006 Apr;34(4):630-6. doi: 10.1177/0363546505281808. Epub 2005 Dec 19.
Results Reference
background
PubMed Identifier
18978450
Citation
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.
Results Reference
background
PubMed Identifier
14669960
Citation
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.
Results Reference
background
PubMed Identifier
21041965
Citation
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.
Results Reference
background
PubMed Identifier
14589467
Citation
Pickar JG. Neurophysiological effects of spinal manipulation. Spine J. 2002 Sep-Oct;2(5):357-71. doi: 10.1016/s1529-9430(02)00400-x.
Results Reference
background
PubMed Identifier
28559754
Citation
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.
Results Reference
background
PubMed Identifier
22488227
Citation
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.
Results Reference
background
PubMed Identifier
18805726
Citation
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.
Results Reference
background
PubMed Identifier
26793035
Citation
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.
Results Reference
background
PubMed Identifier
29187310
Citation
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. Erratum In: J Manipulative Physiol Ther. 2018 Jan 6;:
Results Reference
background
PubMed Identifier
16461174
Citation
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.
Results Reference
background
PubMed Identifier
10714531
Citation
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.
Results Reference
background
PubMed Identifier
10220713
Citation
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.
Results Reference
background
Learn more about this trial
Lumbar Thrust-mobilization Effects on Hip Strength and Anterior Knee Pain
We'll reach out to this number within 24 hrs