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Completed

NCT Number: NCT05467592

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LifeWorks

Shawnee Mission, Kansas, 66226, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Physical Therapy

Primary outcomes

  1. Percentage of patients with knee OA, CLBP, and CNP presenting with CS symptoms.

    Time frame: Through study completion, up to 16 weeks

    Percentage of patients with knee OA, CLBP, and CNP presenting with CS symptoms.

  2. 2011 Fibromyalgia (FM) survey

    Time frame: 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

  3. Beck Anxiety Inventory

    Time frame: 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

  4. Pittsburg sleep scale

    Time frame: 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

  5. Fear Avoidance Questionnaire

    Time frame: Through study completion, up to 16 weeks

    A standard questionnaire to examine fear related to work and physical activities.

  6. Lower Extremity Functional Scale (LEFS) for patients with knee OA

    Time frame: Through study completion, up to 16 weeks

    LEFS is a 20-question survey about the participant's ability to perform everyday tasks.

  7. Neck Disability Index (NDI) for patients with CNP

    Time frame: 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.

  8. Oswestry Disability Index (ODI) for patients with CLBP

    Time frame: 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.

  9. Physical Therapy examination data

    Time frame: 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

  10. Functional Exam as part of routine primary PT

    Time frame: Through study completion, up to 16 weeks

    Routine PT functional assessment includes gait, sit-to-stand, stair climbing, and squats

  11. Neck flexor muscle performance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2022
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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