N/A
Completed N=50
Orthotic Use for Chronic Low Back Pain
Source: ClinicalTrials.gov NCT00976664 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Visual Analog Scale (VAS) — 5.0; 4.3; 2.8; 4.1 units on a scale — p=.0007
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale (VAS) |
5.0; 4.3; 2.8; 4.1; 2.7; 2.9 | .0007 sig |
| PRIMARY Oswestry Disability Index (ODI) |
10.0; 10.4; 6.2; 10.2; 6.1; 8.9 | .002 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00976664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.