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Completed

NCT Number: NCT00976664

Orthotic Use for Chronic Low Back Pain

The purpose of this research study is to determine the change in perceived levels of pain and dysfunction in 50 patients with chronic low back pain, following the use of custom-made shoe orthotics for a three month period. The hypothesis of this study is that custom orthotic intervention will improve the patients' low back pain and dysfunction symptoms.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University of Health Sciences

Lombard, Illinois, 60148, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and females must be at least 18 years old.
  • Subjects must be symptomatic with current pain between T12 and the Sacroiliac joints with or without radiating pain.
  • Symptoms must have been present for at least three months.

Exclusion criteria

  • Use of custom-made shoe orthotics in the past year
  • Brain disorders (i.e.: dementia or Alzheimer's Disease) that would lead to difficulty in questionnaire completion.
  • Active conservative care (such as physical therapy or chiropractic care) for the low back received in the last six months (excluding the use of oral medications or daily at-home exercises for general well-being). We do not want to over-treat the patient or have any cross-over effects within this study from previous treatment.
  • Not fluent or literate in the English language. We will not be able to provide multiple translators within this pilot study.
  • Current or future litigation for low back pain.
  • Chronic pain other then low back pain such as fibromyalgia
  • Low back surgery in last six months.
  • Other conditions that may affect the outcomes of this study or exclude patients from participation in the study, including contraindications to orthotic use.
  • Peripheral neuropathy due to disorders such as diabetes.
  • Low back or leg pain that is not reproducible.

Treatment and study plan

Shoe orthotic

Device

Shoe orthotics are devices worn in the shoe to modify the patient's stance and gait.

Shoe Orthotic Wait Group

Device

This group receives the custom-made shoe orthotics at week 6 of the 12 week treatment program rather than week 1.

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: Randomization, Week 6, and Week 12

    This scale measures pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A higher score on this scale indicates a worse outcome or increase in pain.

  2. Oswestry Disability Index (ODI)

    Time frame: Randomization, Week 6, and Week 12

    This index measures the functional disability of the subject, points on this index can range from 0-50. A higher numeric value on this scale indicates a worse outcome or increased disability (e.g. 0-10: minimal disability; 11-20: moderate disability; 21-30: severe disability; 31-50: crippling). Absolute scores are reported in the data table.

Sponsors and collaborators

Lead sponsor

National University of Health Sciences

Other

Collaborators

  • Foot Levelers, Inc.

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 14, 2009
Registry last updated
May 3, 2017

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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