Lumbar Manipulation for Hip and Muscle Strength

N/ACompletedNCT03101956

NYU Langone Health42 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Patellofemoral Pain Syndrome Anterior Knee Pain Syndrome

Interventions

Lumbar Spine ManipulationPROCEDURE

• 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.

Lumbar Spine Manipulation PlaceboPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

New York University School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 1 Day

Secondary Outcomes

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

Numeric Pain Rating Scale

Time frame: 1 Day

Data from ClinicalTrials.gov

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