Lumbar Manipulation for Hip and Muscle Strength

Patellofemoral Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101956
• Other study ID #: 16-01718
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: June 21, 2019

Study information

• Verified date: November 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Knee Pain Syndrome
• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Procedure:
• Lumbar Spine Manipulation
• 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 Placebo
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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 Day
Primary	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	1 Day
Secondary	Subject's report of pain on the Numeric Pain Rating Scale (NPRS) at rest	Numeric Pain Rating Scale	1 Day