Lumbar Manipulation for Hip and Muscle Strength

Spinal Manipulation for Improving Hip and Knee Muscle Strength in Patients With Patellofemoral Pain Syndrome - A Randomized, Placebo-Controlled, Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Patellofemoral Pain Syndrome; Anterior Knee Pain Syndrome
• Intervention / Treatment: Procedure: Lumbar Spine Manipulation; Procedure: Lumbar Spine Manipulation Placebo

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Strength using dynamometer	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.	1 Day
Score on European Quality of Life-5 Dimensions Questionnaire (EQ-5D)	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	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject's report of pain on the Numeric Pain Rating Scale (NPRS) at rest	Numeric Pain Rating Scale	1 Day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): June 21, 2019
• Study Completion (ACTUAL): June 21, 2019

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (ACTUAL): April 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Spine Manipulation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Syndrome; Somatoform Disorders; Patellofemoral Pain Syndrome
• Other Study ID Numbers: 16-01718

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No