Clinical trial NCT05467592: Central Sensitization in Patients Seeking Outpatient Physical Therapy Services
Official title: Central Sensitization in Patients Seeking Outpatient Physical Therapy Services
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Knee Osteoarthritis
Neck Pain
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects over the age of 18 with knee OA, CLBP, and CNP will be asked to consent.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with knee OA, CLBP, and CNP presenting with CS symptoms.
timeFrame: Through study completion, up to 16 weeks
measure: 2011 Fibromyalgia (FM) survey
timeFrame: Through study completion, up to 16 weeks
measure: Beck Anxiety Inventory
timeFrame: Through study completion, up to 16 weeks
measure: Pittsburg sleep scale
timeFrame: Through study completion, up to 16 weeks
measure: Fear Avoidance Questionnaire
timeFrame: Through study completion, up to 16 weeks
measure: Lower Extremity Functional Scale (LEFS) for patients with knee OA
timeFrame: Through study completion, up to 16 weeks
measure: Neck Disability Index (NDI) for patients with CNP
timeFrame: Through study completion, up to 16 weeks
measure: Oswestry Disability Index (ODI) for patients with CLBP
timeFrame: Through study completion, up to 16 weeks
measure: Physical Therapy examination data
timeFrame: Through study completion, up to 16 weeks
measure: Functional Exam as part of routine primary PT
timeFrame: Through study completion, up to 16 weeks
measure: Neck flexor muscle performance
timeFrame: Through study completion, up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shawnee Mission
country: United States
facility: LifeWorks
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Neena Sharma
role: PRINCIPAL_INVESTIGATOR
References: