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Completed

NCT Number: NCT03101956

Lumbar Manipulation for Hip and Muscle Strength

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar Spine Manipulation

Procedure
  • 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

Lumbar Spine Manipulation Placebo

Procedure

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

Primary outcomes

  1. 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.

  2. 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

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

    Time frame: 1 Day

    Numeric Pain Rating Scale

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2017
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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