Central Sensitization in Patients Seeking Outpatient Physical Therapy Services

Knee Osteoarthritis Clinical Trial

Official title:

Central Sensitization in Patients Seeking Outpatient Physical Therapy Services

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05467592
• Other study ID #: STUDY00148639
• Status: Not yet recruiting
• Start date: July 18, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: University of Kansas Medical Center
• Contact: Taylor A Rees, DPT
• Phone: 9133754163
• Email: trees[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Low Back Pain
• Neck Pain
• Osteoarthritis, Knee

Intervention

Other:
• Standard Physical Therapy care
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.

Locations

Country	Name	City	State
United States	LifeWorks	Shawnee Mission	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Fear Avoidance Questionnaire	A standard questionnaire to examine fear related to work and physical activities.	Through study completion, up to 16 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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