Central Mechanism of Manual Therapy for Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Spinal Manipulation; Other: Placebo Spinal Manipulation

• Registration Number: NCT03078114
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2016-05
• Study Completion: 2016-08
• Status Verified: 2017-03
• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-03-10
• Last Update Submitted: 2017-03-10
• Study First Posted: 2017-03-13
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal Manipulation	Spinal Manipulation	Subjects with subacute low back pain. Subjects will receive 6 treatments of Spinal Manipulation (SM) over 2 consecutive weeks
Placebo Spinal Manipulation	Placebo Spinal Manipulation	Subjects with subacute low back pain. Subjects will be asked to visit the clinic for 6 times. The clinician will go through SM motions but the spine will not actually be manipulated.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

University of Saint Mary; 🇺🇸 Leavenworth, Kansas, United States

University Of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States