Low Back PainNCT07582705
Measuring Reliability of Spine Mobilization in Low Back Pain
An observational study of Low Back Pain and Low Back Ache, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This observational study aims to learn how to measure joint motion and tissue response when pressure is applied to the back and examine how the nervous system responds to the applied pressure. This pressure or mobilization technique is a standard care but we currently do not have a method to measure this technique. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Low Back Ache, Low Back Pain, Mechanical
- What is being tested?
- Spinal mobilization
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2024to 2 Feb 2025
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A convenience sample of healthy subjects (faculty and students, n=25) and subjects with chronic low back pain (n=25) will be recruited from the KUMC campus. Subjects will be excluded if they report lumbar bony or joint pathology (i.e. osteoporosis, rheumatoid arthritis), lumbar/sacral deformities (i.e. spondylolisthesis, spina bifida), spinal surgery, have BMI >30, or are pregnant.
Who may be able to join
- Healthy individuals without current or recent history (within 6 months) of low back pain
- 18-70 years of age
- BMI between 18.5-29.9
- Ability to read and understand English
- For those with chronic low back pain: 1) low back pain more than 3 months and 2) a minimal pain level of 3 on the 0-10 pain numerical rating scale (NRS) in the last 7 days
Who cannot join
- Any signs or symptoms of lumbar pathology (as reported by the participant during interview such as low back pain, or lower limb neurological signs)
- History of any spinal surgery
- Lumbar/sacral conditions reported by the subject such as spondylolithesis, spina bifida or spinal fracture
- Bony pathology such as osteoporosis or rheumatoid arthritis as reported by the participant
- Pregnancy
- Spine cancer
Show all 13Show fewer
- BMI >30
- Unable to lay on stomach
- Resting blood pressure more than 160/90 mmHg
- Currently taking blood thinning medications
- Uncontrolled diabetes
- A medical exclusion from having blood pressure taken such as a peripheral neuropathy
- Low signal to noise ratio fNIRS signal during calibration/setup
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66103
About this study
This observational study aims to learn how to measure joint motion and tissue response when pressure is applied to the back and examine how the nervous system responds to the applied pressure. This pressure or mobilization technique is a standard care but we currently do not have a method to measure this technique. Through this study, we hope to validate a tool that allows physical therapists to measure the pressure applied during spinal mobilization.
Participants will be asked to:
- Receive spinal mobilization
- Participate in pain threshold testing
- Answer questionnaires
- Conditions
- Low Back Pain, Low Back Ache, Low Back Pain, Mechanical, Low Back Pain, Posterior Compartment, Low Back Pain, Postural, Low Back Pain, Recurrent
- Being tested
- Spinal mobilization
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal mobilizationProcedure or surgery
The application of manual pressure to stiff spinal segments to improve mobility and control pain.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Spinal mobilization Receives: Procedure: Spinal mobilization | |
| Chronic Low Back Pain Participants | Spinal mobilization Receives: Procedure: Spinal mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint displacement as measured by the laboratory methods and from the lumbar mobilization feedback system.
The amount of joint motion for a given grade as measured by the laboratory methods and from the lumbar mobilization feedback system.
Measured: Change from Baseline (day1) to immediately post-treatment (day 1)
Applied forces as measured by the laboratory methods and lumbar mobilization feedback system
The magnitude of force produced by the clinician for each grade as measured by the laboratory methods and lumbar mobilization feedback system
Measured: Change from Baseline (day1) to immediately post-treatment (day 1)
Tissue resistance as measured by laboratory methods and the lumbar mobilization feedback system
The degree of stiffness of the joint measured as measured by laboratory methods and the lumbar mobilization feedback system
Measured: Change from Baseline (day1) to immediately post-treatment (day 1)
Change in muscle activation as measured by electromyography
Differences in recorded electromyography (EMG) activity before and after administration of the intervention
Measured: Change from Baseline (day1) to immediately post-treatment (day 1)
Change in pain threshold as measured by quantitative sensory testing.
The following tests will be used to test sensation threshold before and after grade I - IV mobilization/clinician: pressure pain threshold, conditioned pain modulation, and temporal summation.
Measured: Change from Baseline (day1) to immediately post-treatment (day 1)
Brain functional connectivity as measured by functional near infrared spectroscopy
Functional near infrared spectroscopy (fNIRS) is a portable, non-invasive, and inexpensive brain imaging method of monitoring cerebral hemodynamic activity.
Measured: Change from Baseline (day1) to immediately post-treatment (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start2 Oct 2024
- Primary completion2 Feb 2025
- Study completion2 Feb 2025
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582705
- Sponsor's protocol ID
- STUDY00148661
- Status last verified
- May 2026
- First submitted
- 12 May 2025
- Last updated
- 13 May 2026
- 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Reliability of Spine Mobilization in Low Back Pain
- ClinicalTrials.gov ID
- NCT07582705
- Acronym / sponsor ID
- STUDY00148661
- Conditions
- Low Back Pain, Low Back Ache, Low Back Pain, Mechanical, Low Back Pain, Posterior Compartment, Low Back Pain, Postural, Low Back Pain, Recurrent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 13 May 2026 (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 observational study aims to learn how to measure joint motion and tissue response when pressure is applied to the back and examine how the nervous system responds to the applied pressure. This pressure or mobilization technique is a standard care but we currently do not have a method to measure this technique. Through this study, we hope to validate a tool that allows physical therapists to measure the pressure applied during spinal mobilization.
Participants will be asked to:
- Receive spinal mobilization
- Participate in pain threshold testing
- Answer questionnaires
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | – | Procedure: Spinal mobilizationSpinal mobilization |
| Chronic Low Back Pain Participants | – | Procedure: Spinal mobilizationSpinal mobilization |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A convenience sample of healthy subjects (faculty and students, n=25) and subjects with chronic low back pain (n=25) will be recruited from the KUMC campus. Subjects will be excluded if they report lumbar bony or joint pathology (i.e. osteoporosis, rheumatoid arthritis), lumbar/sacral deformities (i.e. spondylolisthesis, spina bifida), spinal surgery, have BMI >30, or are pregnant.
Key inclusion criteria (5 listed)
- Healthy individuals without current or recent history (within 6 months) of low back pain
- 18-70 years of age
- BMI between 18.5-29.9
- Ability to read and understand English
- For those with chronic low back pain: 1) low back pain more than 3 months and 2) a minimal pain level of 3 on the 0-10 pain numerical rating scale (NRS) in the last 7 days
Key exclusion criteria (13 listed)
- Any signs or symptoms of lumbar pathology (as reported by the participant during interview such as low back pain, or lower limb neurological signs)
- History of any spinal surgery
- Lumbar/sacral conditions reported by the subject such as spondylolithesis, spina bifida or spinal fracture
- Bony pathology such as osteoporosis or rheumatoid arthritis as reported by the participant
- Pregnancy
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 |
|---|---|---|
| Spinal mobilizationThe application of manual pressure to stiff spinal segments to improve mobility and control pain. | Procedure or surgery | Chronic Low Back Pain Participants, Healthy Participants |
Primary outcome
Joint displacement as measured by the laboratory methods and from the lumbar mobilization feedback system.
Time frame: Change from Baseline (day1) to immediately post-treatment (day 1)
The amount of joint motion for a given grade as measured by the laboratory methods and from the lumbar mobilization feedback system.
Applied forces as measured by the laboratory methods and lumbar mobilization feedback system
Time frame: Change from Baseline (day1) to immediately post-treatment (day 1)
The magnitude of force produced by the clinician for each grade as measured by the laboratory methods and lumbar mobilization feedback system
Tissue resistance as measured by laboratory methods and the lumbar mobilization feedback system
Time frame: Change from Baseline (day1) to immediately post-treatment (day 1)
The degree of stiffness of the joint measured as measured by laboratory methods and the lumbar mobilization feedback system
Change in muscle activation as measured by electromyography
Time frame: Change from Baseline (day1) to immediately post-treatment (day 1)
Differences in recorded electromyography (EMG) activity before and after administration of the intervention
Change in pain threshold as measured by quantitative sensory testing.
Time frame: Change from Baseline (day1) to immediately post-treatment (day 1)
The following tests will be used to test sensation threshold before and after grade I - IV mobilization/clinician: pressure pain threshold, conditioned pain modulation, and temporal summation.
Brain functional connectivity as measured by functional near infrared spectroscopy
Time frame: Change from Baseline (day1) to immediately post-treatment (day 1)
Functional near infrared spectroscopy (fNIRS) is a portable, non-invasive, and inexpensive brain imaging method of monitoring cerebral hemodynamic activity.
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 13 May 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Low Back Ache, 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 5 inclusion and 13 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 13 May 2026. 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?
Joint displacement as measured by the laboratory methods and from the lumbar mobilization feedback system. (time frame: Change from Baseline (day1) to immediately post-treatment (day 1)). The study lists 6 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 13 May 2026.