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Clinical Trials/NCT03101956
NCT03101956
Completed
Not Applicable

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

NYU Langone Health1 site in 1 country42 target enrollmentMarch 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patellofemoral Pain Syndrome
Sponsor
NYU Langone Health
Enrollment
42
Locations
1
Primary Endpoint
Muscle Strength using dynamometer
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
June 21, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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
  • 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

Outcomes

Primary Outcomes

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.

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 Outcomes

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

Study Sites (1)

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