Lumbar Manipulation for Hip and Muscle Strength

Not Applicable

Completed

• Conditions: Patellofemoral Pain Syndrome; Anterior Knee Pain Syndrome
• Interventions: Procedure: Lumbar Spine Manipulation Placebo; Procedure: Lumbar Spine Manipulation

• Registration Number: NCT03101956
• Lead Sponsor: 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

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 Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-04-05
• Primary Completion: 2019-06-21
• Study Completion: 2019-06-21
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Lumbar Spine Manipulation Placebo	-
L/S Manipulation Study Group	Lumbar Spine Manipulation	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Subject's report of pain on the Numeric Pain Rating Scale (NPRS) at rest	1 Day	Numeric Pain Rating Scale

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States