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

NCT06554236 | Not Yet Recruiting

• 1 other identifier: C.2024.071d
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Keywords

two-point discrimination; physical therapy; somatoperception; tactile acuity

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).

• Low back perception

  Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).

• Tactile Localization Accuracy

  Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).

• Function

  Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).

Study Arms (1)

Chronic low back pain

EXPERIMENTAL

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

Other: physical therapy and sensory training

Interventions

physical therapy and sensory training OTHER

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

Chronic low back pain

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DEERS eligible
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Brooke Barletta

  Brooke AMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brooke Barletta, DPT

CONTACT

808-391-6929; brooke.a.barletta.mil@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: quasi-experimental, one-group repeated measures design

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 15, 2024
• Study Start: August 31, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Requests for deidentified data will be considered on a case by case basis.
• Access Criteria: Requests for deidentified data will be considered on a case by case basis.