Clinical trial NCT03101956: Lumbar Manipulation for Hip and Muscle Strength
Official title: Spinal Manipulation for Improving Hip and Knee Muscle Strength in Patients With Patellofemoral Pain Syndrome - A Randomized, Placebo-Controlled, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Anterior Knee Pain Syndrome
Keywords: Spine Manipulation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Muscle Strength using dynamometer
timeFrame: 1 Day
measure: Score on European Quality of Life-5 Dimensions Questionnaire (EQ-5D)
timeFrame: 1 Day
Secondary outcomes:
measure: Subject's report of pain on the Numeric Pain Rating Scale (NPRS) at rest
timeFrame: 1 Day
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Michael D'Agati, MD
role: PRINCIPAL_INVESTIGATOR
References: