The Influence of an Orthopaedic Manual Physical Therapy and Sensory Training on Somatoperception in Patients with Chronic Low Back Pain

NCT ID: NCT06554236

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2025-06-30

Brief 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.

Conditions

Low Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chronic low back pain

18-64 years with low back pain duration \> 3 months.

Group Type: EXPERIMENTAL

physical therapy and sensory training

Intervention Type: OTHER

Physical therapy standard of care and 5 minutes of sensory training.

Interventions

physical therapy and sensory training

Physical therapy standard of care and 5 minutes of sensory training.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brooke Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Brooke Barletta

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brooke Barletta

Role: PRINCIPAL_INVESTIGATOR

Brooke AMC

Central Contacts

Brooke Barletta, DPT

Role: CONTACT

brooke.a.barletta.mil@health.mil

808-391-6929

Other Identifiers

C.2024.071d

Identifier Type: -

Identifier Source: org_study_id