Low Back PainNCT05467592
Central Sensitization in Patients Seeking Outpatient Physical Therapy Services
An observational study of Low Back Pain and Knee Osteoarthritis, run by University of Kansas Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Knee Osteoarthritis, Neck Pain
- What is being tested?
- Standard Physical Therapy care
- Type of treatment
- Injection or infusion
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to 22 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All subjects over the age of 18 with knee OA, CLBP, and CNP will be asked to consent.
Who may be able to join
- Diagnosis of knee, neck, or back pain
- Chronic pain as defined pain > 3 months
- Able to read and understand English
Who cannot join
- Pregnancy
- Pain less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Low Back Pain, Knee Osteoarthritis, Neck Pain
- Being tested
- Standard Physical Therapy care
- Medical subject headings
- Low Back Pain, Osteoarthritis, Knee, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Physical Therapy careOther
Also called Physical Therapy
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, up to 16 weeks
Fear Avoidance Questionnaire
A standard questionnaire to examine fear related to work and physical activities.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Through study completion, up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start6 Jun 2022
- Primary completion22 Jan 2024
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neena Sharma, PT, PhD, CMPT, University of Kansas Medical Center
- Investigators
- Neena Sharma, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467592
- Sponsor's protocol ID
- STUDY00148639
- Status last verified
- May 2025
- First submitted
- 16 May 2022
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Sensitization in Patients Seeking Outpatient Physical Therapy Services
- ClinicalTrials.gov ID
- NCT05467592
- Acronym / sponsor ID
- STUDY00148639
- Conditions
- Low Back Pain, Knee Osteoarthritis, Neck Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All subjects over the age of 18 with knee OA, CLBP, and CNP will be asked to consent.
Key inclusion criteria (3 listed)
- Diagnosis of knee, neck, or back pain
- Chronic pain as defined pain > 3 months
- Able to read and understand English
Key exclusion criteria (2 listed)
- Pregnancy
- Pain less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Physical Therapy careAlso: Physical TherapyAll 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 | – |
Primary outcome
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.
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
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
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
Fear Avoidance Questionnaire
Time frame: Through study completion, up to 16 weeks
A standard questionnaire to examine fear related to work and physical activities.
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.
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.
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.
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neena Sharma principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Knee Osteoarthritis, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with knee OA, CLBP, and CNP presenting with CS symptoms. (time frame: Through study completion, up to 16 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.