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Completed

NCT Number: NCT03760887

A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain

To determine if there is any carry over difference with sensation training to the low back for patients with low back pain with the addition of a training at home. This will be looked at to see if there is a difference in pain or back / leg movement right after the training and in a few days after doing some exercises at home.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Ambrose university

Davenport, Iowa, 52803, United States

About this study

In a previous case series patients with chronic Low Back Pain (LBP) who received tactile acuity training to their lower back in the absence of movement, experienced immediate positive changes in pain ratings and spinal movements. These changes, however, where only measured immediate post-intervention. This study aims to use a similar design of sensory discrimination for LBP, but will include a sensory discrimination home exercise program and compare groups at a follow-up visit for any difference between groups (48-96 hours) of the immediate changes. Changes will be assessed for pain and back and leg movement.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • adults over the age of 18
  • patients presenting at PT with a primary complaint of LBP
  • LBP being present for 3 months or more
  • fluent in English
  • willing to participate in the study
  • They also will need someone who can assist with a sensory discrimination HEP.

Exclusion criteria

  • under age 18
  • not able to read/understand the English language
  • prisoners
  • no medical issues precluding physical therapy treatment (red flags)
  • if they had undergone spinal surgery
  • if they had any skin or medical condition preventing them from receiving tactile stimuli on the lower back or had specific movement-based precautions, i.e., no active spinal flexion. - Patients presenting with leg pain only
  • Patients with neurological deficit only in the lower extremity

Treatment and study plan

Home exercise program only

Other

After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program only

Home exercise program and home program of sensory discrimination

Other

After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program and two 5 minutes sessions of sensory training at home each day.

Primary outcomes

  1. Low Back Pain Rating

    Time frame: Change from baseline to following treatment immediately upon completion of initial session

    Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)

  2. Low Back Pain Rating

    Time frame: Change from end of treatment initial session to 2-4 days

    Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)

  3. Lumbar Flexion

    Time frame: Change from baseline to treatment immediately upon completion of initial session

    Active trunk forward flexion measured in cm (finger tips to floor)

  4. Lumbar Flexion

    Time frame: Change from end of treatment initial session to 2-4 days

    Active trunk forward flexion measured in cm (finger tips to floor)

  5. Straight Leg Raise

    Time frame: Change from baseline to treatment immediately upon completion of initial session

    Neurodynamic measurement of leg raise (lower limb tension test)

  6. Straight Leg Raise

    Time frame: Change from end of treatment initial session to 2-4 days

    Neurodynamic measurement of leg raise (lower limb tension test)

Sponsors and collaborators

Lead sponsor

St. Ambrose University

Other

Registry information

Official study title

A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain: a Randomized Control Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 30, 2018
Registry last updated
Apr 23, 2019

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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