The Influence of an Orthopaedic Manual Physical Therapy and Sensory Training on Somatoperception … (NCT06554236) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Influence of an Orthopaedic Manual Physical Therapy and Sensory Training on Somatoperception in Patients with Chronic Low Back Pain
48 participantsStarted 2024-08-31
Plain-language 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. 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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tactile acuity as measured by two-point discrimation
Timeframe: Performed at baseline visit, 4th week of treatment, and at final visit (8 +/- 2 weeks).