Central Sensitization in Patients Seeking Outpatient Physical Therapy Services

Study Overview
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Brief Summary
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This is an observational study to examine presence of CS in patients with knee osteoarthritis (OA), chronic LBP (CLBP), and chronic neck pain (CNP) seeking outpatient physical therapy (PT) services. The study will also examine if outcomes differ between patients with CS and patients without CS symptoms with standard PT interventions.

Detailed Description
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Central Sensitization (CS), defined as augmented pain processing, is common in subgroup of nearly all chronic pain conditions, including fibromyalgia, CLBP, OA, and chronic tension headache. However, current studies of CS are primarily limited to research settings, lacking the knowledge about prevalence of CS and rehabilitation outcomes in usual clinical care. Practicing clinicians do not routinely assess for CS symptoms. Without proper screening for CS, and lack of knowledge of varying levels of nervous system involvement contributing to pain, clinicians are unable to fully identify the depth of the mechanisms and therefore unable to fully determine the best treatment strategies. This observational study addresses this gap in knowledge by screening patients for CS symptoms.

Official Title
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Central Sensitization in Patients Seeking Outpatient Physical Therapy Services

Conditions
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Low Back Pain, Knee Osteoarthritis, Neck Pain

Intervention / Treatment
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* Other: Standard Physical Therapy care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of knee, neck, or back pain Chronic pain as defined pain > 3 months Able to read and understand English Exclusion Criteria: Pregnancy Pain less than 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Standard Physical Therapy care|All therapy will be given as it would have routinely been administered in the clinic. Standard care for all patients includes physical therapy and chiropractic treatment at each visit. There is a nurse practitioner on site. If necessary, patients can receive trigger point injections to the musculature around the back and neck, platelet rich plasma, or headache injections by the nurse practitioner. These interventions vary on a case by case basis. Involvement in the study will not impact the patients plan of care. We will collect this information as confounders and factor into statistical analysis.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with knee OA, CLBP, and CNP presenting with CS symptoms. | Percentage of patients with knee OA, CLBP, and CNP presenting with CS symptoms. | Through study completion, up to 16 weeks | 
| 2011 Fibromyalgia (FM) survey | A standard questionnaire for centralized pain. Scores 3-6 in widespread pain index and 9 or greater in symptom severity suggest widespread pain | Through study completion, up to 16 weeks | 
| Beck Anxiety Inventory | A standard questionnaire with 21 questions. Scores 0-21=low anxiety, scores 22-35=moderate anxiety and scores 36 and above=potentially concerning level of anxiety | Through study completion, up to 16 weeks | 
| Pittsburg sleep scale | A standard questionnaire to examine sleep problems. A total of 5 scores or greater indicate poor sleep quality | Through study completion, up to 16 weeks | 
| Fear Avoidance Questionnaire | A standard questionnaire to examine fear related to work and physical activities. | Through study completion, up to 16 weeks | 
| Lower Extremity Functional Scale (LEFS) for patients with knee OA | LEFS is a 20-question survey about the participant's ability to perform everyday tasks. | Through study completion, up to 16 weeks | 
| Neck Disability Index (NDI) for patients with CNP | NDI is a 10-question survey in which participants check a box corresponding to how their neck pain impacts their activities of daily living. | Through study completion, up to 16 weeks | 
| Oswestry Disability Index (ODI) for patients with CLBP | ODI is a 10-question survey in which participants check a box corresponding to how their low back pain impacts their activities of daily living. | Through study completion, up to 16 weeks | 
| Physical Therapy examination data | Routine PT subjective and objective examination data that includes history taking, range of motion, muscle testing, and neurological exam if necessary | Through study completion, up to 16 weeks | 
| Functional Exam as part of routine primary PT | Routine PT functional assessment includes gait, sit-to-stand, stair climbing, and squats | Through study completion, up to 16 weeks | 
| Neck flexor muscle performance | Strength and endurance. Strength will be tested manually with 0-5 MMT standard grading scale or with use of dynamometer for strength and endurance performance of individual muscles. | Through study completion, up to 16 weeks |