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NCT Number: NCT06554236

The Influence of an Orthopaedic Manual Physical Therapy 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.

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Key information

Conditions

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

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physical therapy and sensory training

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Pain as measured by numeric pain rating scale

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

    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)

  2. Low back perception

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

    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

  3. Tactile Localization Accuracy

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

    measured by the number of correct responses out of 9 attempts for stimulation of the 9-grid chart

  4. Function

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Brooke Barletta, DPT

CONTACT

[email protected]

808-391-6929

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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