Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lumbar Manipulation for Hip and Muscle Stregth

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: NCT03101956
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The aim of this double blind, randomized, placebo-controlled clinical trial is to investigate the immediate effects of spinal manipulation on hip and knee muscle strength and pain-free deep squat range of motion in order to answer several conceptual and practical research questions

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Anterior Knee Pain Syndrome Procedure: Lumbar Spine Manipulation Procedure: Lumbar Spine Manipulation Placebo Not Applicable

Detailed Description:
This prospective, double-blind, randomized control trial clinical will use a multigroup pretest-posttest control design with 1 treatment arm and 1 control arm. Interpreted within the biopsychosocial model and the International Classification of Functioning, Disability and Health (ICF) framework, this research will measure the outcomes between patellofemoral pain syndrome (PFPS), the health condition, and contextual factors, particularly personal factors. It will address personal factors such as gender and age but will not address environmental factors. This research includes tests and measures of two of the three levels of human functioning, or domains, impairments to body functions and structures and activity limitations. Muscle strength testing is an impairment-level measure and pain-free deep squat range of morion (ROM) is an activity limitation-level measure.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Spinal Manipulation for Improving Hip and Knee Muscle Strength in Patients With Patellofemoral Pain Syndrome - A Randomized, Placebo-Controlled, Clinical Trial
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: L/S Manipulation Study Group Procedure: Lumbar Spine Manipulation
• The subject will be placed in sidelying on a treatment table. Facing the subject, the therapist will position the subject's superior thigh in flexion and rotate the subject's upper trunk to the opposite side. The therapist will place his cephalad forearm along the subject's superior lateral trunk and the caudal forearm along the subject's iliac crest and lateral hip. Lastly, the therapist will roll the subject towards himself or herself.
Other Name: Sidelying lumbosacral thrust joint manipulation

Active Comparator: Control Group Procedure: Lumbar Spine Manipulation Placebo
The subject will be placed in sidelying on a treatment table. Facing the subject, the therapist will position both hips and knees in approximately 45° of flexion. The therapist will place his or her cephalad forearm along the subject's superior lateral trunk and the caudal forearm along the subject's iliac crest and lateral hip. Lastly, the therapist will roll the subject towards himself or herself.
Other Name: Sidelying lumbosacral thrust joint manipulation placebo




Primary Outcome Measures :
  1. Muscle Strength using dynamometer [ Time Frame: 1 Day ]
    Hand-held dynamometry involves the use of a dynamometer that is held by a tester and applied to the tested segment of a patient's body.

  2. Score on European Quality of Life-5 Dimensions Questionnaire (EQ-5D) [ Time Frame: 1 Day ]
    The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems


Secondary Outcome Measures :
  1. Subject's report of pain on the Numeric Pain Rating Scale (NPRS) at rest [ Time Frame: 1 Day ]
    Numeric Pain Rating Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Referred to out-patient physical therapy for a knee condition and a chief complaint of anterior knee pain
  • Anterior knee pain with squatting
  • Agreed to be in the study and signed the informed consent document

Exclusion Criteria:

  • Presence of any medical 'red flags' suggestive of pain that is not of musculoskeletal origin
  • Osteoporosis or recent fracture of the hip or spinal joints
  • Spinal or hip joint surgery or prosthesis
  • Knee surgery on the affected knee within the last 6 months
  • Spinal instability (Grade II spondylolithesis or greater), spondyloarthritides, or severe spinal misalignment
  • Nervous system disease or disorder
  • Pregnant
  • Lumbar nerve root compression (any of the following signs present)
  • Positive straight leg raise (SLR) test less than 45°
  • Marked paresis involving a major muscle group of the lower extremity
  • Diminished, and asymmetric (lower than uninvolved side), lower extremity
  • muscle stretch reflex
  • Diminished or absent sensation to pinprick in any lower extremity dermatome

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): NCT03101956


Contacts
Layout table for location contacts
Contact: Olanta Chandler 212-263-0844 olanta.chandler@nyumc.org
Contact: Olanta Chandler olanta.chandler@nyumc.org

Locations
Layout table for location information
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Olanta Chandler       olanta.chandler@nyumc.org   
Principal Investigator: Michael D'Agati, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: Michael D'Agati, MD NYU Langone Health

Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03101956     History of Changes
Other Study ID Numbers: 16-01718
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NYU Langone Health:
Spine Manipulation

Additional relevant MeSH terms:
Layout table for MeSH terms
Syndrome
Somatoform Disorders
Patellofemoral Pain Syndrome
Disease
Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases