Lumbar Manipulation for Hip and Muscle Strength

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome

Intervention / Treatment
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* Procedure: Lumbar Spine Manipulation
* Procedure: Lumbar Spine Manipulation Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L/S Manipulation Study Group<br> | Procedure: Lumbar Spine Manipulation<br>* • 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.<br>* Other names: Sidelying lumbosacral thrust joint manipulation;|
| Active Comparator: Control Group<br> | Procedure: Lumbar Spine Manipulation Placebo<br>* 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.<br>* Other names: Sidelying lumbosacral thrust joint manipulation placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's report of pain on the Numeric Pain Rating Scale (NPRS) at rest | Numeric Pain Rating Scale | 1 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spine Manipulation