Central Sensitization in Patients Seeking Outpatient Physical Therapy Services

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Knee Osteoarthritis; Neck Pain
• Intervention / Treatment: Other: Standard Physical Therapy care

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.

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Shawnee Mission, Kansas, United States, 66226
      • LifeWorks

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Neena Sharma, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Actual): January 22, 2024
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Neck Pain
• Other Study ID Numbers: STUDY00148639

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No