Lumbar Manipulation for Hip and Muscle Strength

NCT ID: NCT03101956

Last Updated: 2020-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-06-21

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.

Conditions

Patellofemoral Pain Syndrome; Anterior Knee Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

L/S Manipulation Study Group

Group Type: EXPERIMENTAL

Lumbar Spine Manipulation

Intervention Type: 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.

Control Group

Group Type: ACTIVE_COMPARATOR

Lumbar Spine Manipulation Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Sidelying lumbosacral thrust joint manipulation; Sidelying lumbosacral thrust joint manipulation placebo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael D'Agati, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

16-01718

Identifier Type: -

Identifier Source: org_study_id