Central Sensitization in Patients Seeking Outpatient Physical Therapy Services

Completed

• Conditions: Low Back Pain; Knee Osteoarthritis; Neck Pain

• Registration Number: NCT05467592
• Lead Sponsor: University of Kansas Medical Center

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.

Study Timeline

• Study First Submitted: 2022-05-16
• Study Start: 2022-06-06
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-20
• Primary Completion: 2024-01-22
• Study Completion: 2024-01-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

LifeWorks; 🇺🇸 Shawnee Mission, Kansas, United States