The Influence of an Orthopaedic Manual Physical Therapy and Sensory Training on Somatoperception in Patients with Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: physical therapy and sensory training.
- Who it may be relevant to
- Registry conditions: Low Back Pain. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Influence of an Orthopaedic Manual Physical Therapy Approach and Sensory Training on Somatoperception in Patients with Chronic Low Back Pain
Overview
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.
Interventions
- Other physical therapy and sensory training
Physical therapy standard of care and 5 minutes of sensory training.
Primary outcome measures
- 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).]
Secondary outcome measures (4)
- 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).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06554236 · C.2024.071d