Lumbar Manipulation for Hip and Muscle Strength

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT03101956

Collaborator

(none)

Enrollment

Location

Arms

27.7

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

42 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 :

Mar 1, 2017

Actual Primary Completion Date :

Jun 21, 2019

Actual Study Completion Date :

Jun 21, 2019

Arms and Interventions

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 Names: 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 Names: Sidelying lumbosacral thrust joint manipulation placebo

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 Names:

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 Names:

Sidelying lumbosacral thrust joint manipulation placebo

Outcome Measures

Primary Outcome Measures

Muscle Strength using dynamometer [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.
Score on European Quality of Life-5 Dimensions Questionnaire (EQ-5D) [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

Subject's report of pain on the Numeric Pain Rating Scale (NPRS) at rest [1 Day]
Numeric Pain Rating Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Michael D'Agati, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03101956

Other Study ID Numbers:

16-01718

First Posted:

Apr 5, 2017

Last Update Posted:

Nov 3, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by NYU Langone Health

Spine Manipulation

Additional relevant MeSH terms:

Patellofemoral Pain Syndrome

Syndrome

Somatoform Disorders

Study Results

No Results Posted as of Nov 3, 2020