Low Back Pain
Conditions
Brief summary
The purpose of this study is to examine the change of nervous system activity before and after spinal manipulation treatment program in people with low back pain.
Interventions
OTHERSpinal Manipulation
The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to manipulate the spine.
OTHERPlacebo Spinal Manipulation
The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to simulate manipulating the spine.
Sponsors
National Chiropractic Mutual Insurance Company Foundation
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of subacute low back pain * Ability to read and understand English
Exclusion criteria
* Previous low back surgery * Severe structural spinal deformity * Neurological compromise resulting in current nerve root entrapment * Spinal cord compression * Tumor * Severe spinal instability * Severe osteoporosis * Psychiatric disease * Head trauma * Spinal infection * Known cardiovascular or metabolic disease * Known neurological, neuromuscular or orthopedic problems that might prevent them from participating in manual therapy interventions * Pregnancy * Mini-Mental State Examination score \< 25 * Body Mass Index (BMI) \< 18 or \> 30 * Pain or paresthesia below the knees * Systemic illness known to affect sensation i.e. diabetes * Acute and/or chronic pain condition unrelated to LBP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Threshold measured using Pain Pressure Threshold (PPT) testing | Change from Pre-treatment to Post-treatment, 2 Weeks | Outcome will be measured using Pain Pressure Threshold (PPT) testing. Pressure will be applied to subjects using a digital algometer. Three trials for PPT will be done and the mean value will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in function measured using the Oswestry Disability Index (ODI) | Change from Baseline to Week 2 | Outcome will be measured using the Oswestry Disability Index (ODI). Subjects answer to questions. Their responses indicate no impact to great impact. Scores for each question range from 0 to 5. Total score for the ODI is 50. The higher the score, the greater level of disability/function. |
| Change in Low Back Pain measured using the Numerical Pain Rating Scale (NPRS) | Change from Baseline to Week 2 | Outcome will be measured using the Numerical Pain Rating Scale (NPRS). Pain intensity will be assessed using an 11-point scale. Scores on the scale range from 0 indicating no pain, 1 slight pain, and 10 strongest imaginable pain. |
| Change in Fear Avoidance Beliefs Questionnaire (FABQ) | Change from Baseline to Week 2 | The FABQ is completed by the subject. It determines the level of fear and avoidance about work and physical activity. The measure is comprised of two subscales: a four item physical activity subscale (FABQ-W), and a seven-item work subscale (FABQ-W). An elevated FABQ score is predictive of the development of chronic disability in low back pain (LBP) patients. |
Countries
United States
Outcome results
None listed