Central Mechanism of Manual Therapy for Low Back Pain

Low Back Pain Clinical Trial

Official title:

Central Mechanism of Manual Therapy for Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03078114
• Other study ID #: 12919
• Status: Completed
• Phase: N/A
• First received: March 1, 2017
• Last updated: March 10, 2017
• Start date: May 2012
• Est. completion date: August 2016

Study information

• Verified date: March 2017
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• 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 manipulate the spine.
• Placebo 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.

Locations

Country	Name	City	State
United States	University Of Kansas Medical Center	Kansas City	Kansas
United States	University of Saint Mary	Leavenworth	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Chiropractic Mutual Insurance Company Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Threshold measured using Pain Pressure Threshold (PPT) testing	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.	Change from Pre-treatment to Post-treatment, 2 Weeks
Secondary	Change in function measured using the Oswestry Disability Index (ODI)	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 from Baseline to Week 2
Secondary	Change in Low Back Pain measured using the Numerical Pain Rating Scale (NPRS)	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 from Baseline to Week 2
Secondary	Change in Fear Avoidance Beliefs Questionnaire (FABQ)	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.	Change from Baseline to Week 2