Low Back PainNCT06554236
The Influence of an Orthopaedic Manual Physical Therapy and Sensory Training on Somatoperception in Patients with Chronic Low Back Pain
A study testing physical therapy and sensory training in people with Low Back Pain, run by Brooke Army Medical Center.
Trial summary
Individuals with chronic low back pain and other chronic pain conditions have been shown to have altered somatosensory, the ability to sense input to the tissue, which is processed in the primary somatosensory cortex or S1. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- physical therapy and sensory training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2024to Jun 2025
- Phase
- Interventional
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DEERS eligible
- 18 to 64 years old
- Low back pain \> 3 months
- Numeric Pain Rating Scale minimal pain rating of 3/10 in the last seven days
- Must be able to commit to 6-10 treatment sessions over a period of at least 6-we
Who cannot join
- History of spinal surgery
- History of spinal injections or nerve ablations in the past year
- History of traumatic brain injury (TBI)
- History of cerebral vascular accident (CVA)
- Currently pregnant
- Active cancer
Show all 14Show fewer
- Symptoms below the knee
- Non-MSK condition contributing to low back pain
- Chronic Pain Conditions to include Chronic Regional Pain Syndrome and Fibromyalgia
- Autoimmune Diseases (to include Ankylosing Spondylitis, Lupus, Rheumatoid Arthritis)
- Currently under litigation related to low back pain
- Currently going through Medical Evaluation Board (MEB)
- Retiring or separating from the military within a year
- Currently receiving physical therapy for low back pain
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Influence of an Orthopaedic Manual Physical Therapy Approach and Sensory Training on Somatoperception in Patients with Chronic Low Back Pain
Individuals with chronic low back pain and other chronic pain conditions have been shown to have altered somatosensory, the ability to sense input to the tissue, which is processed in the primary somatosensory cortex or S1. Two-point discrimination is currently the best clinical tool utilized to assess an individual's ability to sense touch. This study will assess TPD changes after a course of standard physical therapy care with the addition of sensory training.
- Conditions
- Low Back Pain
- Being tested
- physical therapy and sensory training
- Keywords
- two-point discrimination, physical therapy, somatoperception, tactile acuity
- 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.
physical therapy and sensory trainingOther
Physical therapy standard of care and 5 minutes of sensory training.
| Study group | Role | What they receive |
|---|---|---|
| Chronic low back pain | Experimental | 18-64 years with low back pain duration > 3 months. Receives: Other: physical therapy and sensory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tactile acuity as measured by two-point discrimation
measured using a Caroline 2-point discriminator tool. TPD is the most widely accepted objective measurement of tactile acuity in the clinical setting
Measured: Performed at baseline visit, 4th week of treatment, and at final visit (8 +/- 2 weeks).
Secondary outcomes (4)
Pain as measured by numeric pain rating scale
The NPRS is an 11-point numerical pain rating scale used to measure pain. Patients rate pain ranging between 0 (no pain) and 10 (worst pain imaginable)
Measured: Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).
Low back perception
measured using the Freemont Back Awareness Questionnaire (FreBAQ), a multi-item, self-report questionnaire designed to quantify distorted perception of the back in people with CLBP
Measured: Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).
Tactile Localization Accuracy
measured by the number of correct responses out of 9 attempts for stimulation of the 9-grid chart
Measured: Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).
Function
measured by the Oswestry Disability Index (ODI), 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability
Measured: Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start31 Aug 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- quasi-experimental, one-group repeated measures design
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Brooke Barletta, Brooke Army Medical Center
- Investigators
- Brooke Barletta, Principal investigator, Brooke AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554236
- Sponsor's protocol ID
- C.2024.071d
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for deidentified data will be considered on a case by case basis.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of an Orthopaedic Manual Physical Therapy Approach and Sensory Training on Somatoperception in Patients with Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06554236
- Acronym / sponsor ID
- C.2024.071d
- Conditions
- Low Back Pain
- Keywords
- two-point discrimination, physical therapy, somatoperception, tactile acuity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- 31 Aug 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 15 Aug 2024 (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.
Individuals with chronic low back pain and other chronic pain conditions have been shown to have altered somatosensory, the ability to sense input to the tissue, which is processed in the primary somatosensory cortex or S1. Two-point discrimination is currently the best clinical tool utilized to assess an individual's ability to sense touch. This study will assess TPD changes after a course of standard physical therapy care with the addition of sensory training.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- quasi-experimental, one-group repeated measures design
| Arm | Type | Receives |
|---|---|---|
| Chronic low back pain | Experimental | Other: physical therapy and sensory training18-64 years with low back pain duration > 3 months. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- DEERS eligible
- 18 to 64 years old
- Low back pain \> 3 months
- Numeric Pain Rating Scale minimal pain rating of 3/10 in the last seven days
- Must be able to commit to 6-10 treatment sessions over a period of at least 6-we
Key exclusion criteria (14 listed)
- History of spinal surgery
- History of spinal injections or nerve ablations in the past year
- History of traumatic brain injury (TBI)
- History of cerebral vascular accident (CVA)
- Currently pregnant
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 |
|---|---|---|
| physical therapy and sensory trainingPhysical therapy standard of care and 5 minutes of sensory training. | Other | Chronic low back pain |
Primary outcome
Tactile acuity as measured by two-point discrimation
Time frame: Performed at baseline visit, 4th week of treatment, and at final visit (8 +/- 2 weeks).
measured using a Caroline 2-point discriminator tool. TPD is the most widely accepted objective measurement of tactile acuity in the clinical setting
4 secondary outcomes
Pain as measured by numeric pain rating scale
Time frame: Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).
Low back perception
Time frame: Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).
Tactile Localization Accuracy
Time frame: Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).
Function
Time frame: Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Yes. Requests for deidentified data will be considered on a case by case basis.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Brooke Barletta principal investigator
Brooke AMC
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy and sensory training in people with Low Back Pain, run by Brooke Army Medical Center.
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 14 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: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brooke Barletta, DPT (808-391-6929, brooke.a.barletta.mil@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tactile acuity as measured by two-point discrimation (time frame: Performed at baseline visit, 4th week of treatment, and at final visit (8 +/- 2 weeks).). 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 15 Aug 2024.