Central Sensitization in Patients Seeking Outpatient Physical Therapy Services

NCT05467592 | Completed

• 1 other identifier: STUDY00148639
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Knee Osteoarthritis; Neck Pain

Outcome Measures

Primary Outcomes (11)

• 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

Interventions

Standard Physical Therapy care OTHER

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.

Also known as: Physical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosis of knee, neck, or back pain
• Chronic pain as defined pain \> 3 months
• Able to read and understand English

You may not qualify if:

• Pregnancy
• Pain less than 3 months

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

LifeWorks

Shawnee Mission, Kansas, 66226, United States

Location

MeSH Terms

Conditions

Low Back Pain; Osteoarthritis, Knee; Neck Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Neena Sharma

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: July 20, 2022
• Study Start: June 6, 2022
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)