Central Sensitization in Patients Seeking Outpatient Physical Therapy Services

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05467592
Collaborator
(none)
100
1
17.4
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Central Sensitization in Patients Seeking Outpatient Physical Therapy Services
Anticipated Study Start Date :
Jul 18, 2022
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  3. 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

  4. 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

  5. Fear Avoidance Questionnaire [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 LifeWorks Shawnee Mission Kansas United States 66226

Sponsors and Collaborators

  • University of Kansas Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Neena Sharma, PT, PhD, CMPT, Principal Investigator, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT05467592
Other Study ID Numbers:
  • STUDY00148639
First Posted:
Jul 20, 2022
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022