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

NCT ID: NCT04119310

Last Updated: 2019-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anterior Knee Pain Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to one of two interventions, thrust-mobilization or sham mobilization.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lumbar thrust-mobilization

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

Group Type EXPERIMENTAL

Lumbar-thrust mobilization

Intervention Type OTHER

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.

Sham-mobilization

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

Group Type SHAM_COMPARATOR

Sham thrust-mobilization

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Grade 5 mobilization, manipulation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Messiah College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Karl Bergmann, PT, ScD

Role: CONTACT

717-796-1800 ext. 3339

Amy Humphrey, DPT

Role: CONTACT

717-796-1800 ext. 3035

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29392329 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12570282 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20118526 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18515959 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14992676 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19765240 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17154139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17549951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12098160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23456237 (View on PubMed)

Dixit S, DiFiori JP, Burton M, Mines B. Management of patellofemoral pain syndrome. Am Fam Physician. 2007 Jan 15;75(2):194-202.

Reference Type BACKGROUND
PMID: 17263214 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23016077 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18582383 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10921638 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9809282 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11403109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23016007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12435653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16365375 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18978450 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14669960 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21041965 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 14589467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28559754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22488227 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18805726 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26793035 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29187310 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16461174 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10714531 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10220713 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BergmannHumphrey

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.