Back to resultsLumbar Manipulation for Hip and Muscle Strength
Primary Purpose
Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumbar Spine Manipulation
Lumbar Spine Manipulation Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Spine Manipulation
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
L/S Manipulation Study Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Subject's report of pain on the Numeric Pain Rating Scale (NPRS) at rest
Numeric Pain Rating Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03101956
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
June 21, 2019 (Actual)
Study Completion Date
June 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome
Keywords
Spine Manipulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L/S Manipulation Study Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Lumbar Spine Manipulation
Other Intervention Name(s)
Sidelying lumbosacral thrust joint manipulation
Intervention Description
• 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
Intervention Name(s)
Lumbar Spine Manipulation Placebo
Other Intervention Name(s)
Sidelying lumbosacral thrust joint manipulation placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle Strength using dynamometer
Description
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.
Time Frame
1 Day
Title
Score on European Quality of Life-5 Dimensions Questionnaire (EQ-5D)
Description
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
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Subject's report of pain on the Numeric Pain Rating Scale (NPRS) at rest
Description
Numeric Pain Rating Scale
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D'Agati, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
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Lumbar Manipulation for Hip and Muscle Strength
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