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Central Mechanism of Manual Therapy for Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal Manipulation
Placebo Spinal Manipulation
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Of Kansas Medical Center
  • University of Saint Mary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Spinal Manipulation

Placebo Spinal Manipulation

Arm Description

Subjects with subacute low back pain. Subjects will receive 6 treatments of Spinal Manipulation (SM) over 2 consecutive weeks

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 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.

Full Information

First Posted
March 1, 2017
Last Updated
March 10, 2017
Sponsor
University of Kansas Medical Center
Collaborators
National Chiropractic Mutual Insurance Company Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03078114
Brief Title
Central Mechanism of Manual Therapy for Low Back Pain
Official Title
Central Mechanism of Manual Therapy for Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Chiropractic Mutual Insurance Company Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal Manipulation
Arm Type
Experimental
Arm Description
Subjects with subacute low back pain. Subjects will receive 6 treatments of Spinal Manipulation (SM) over 2 consecutive weeks
Arm Title
Placebo Spinal Manipulation
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Spinal Manipulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Spinal Manipulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain Threshold measured using Pain Pressure Threshold (PPT) testing
Description
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.
Time Frame
Change from Pre-treatment to Post-treatment, 2 Weeks
Secondary Outcome Measure Information:
Title
Change in function measured using the Oswestry Disability Index (ODI)
Description
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.
Time Frame
Change from Baseline to Week 2
Title
Change in Low Back Pain measured using the Numerical Pain Rating Scale (NPRS)
Description
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.
Time Frame
Change from Baseline to Week 2
Title
Change in Fear Avoidance Beliefs Questionnaire (FABQ)
Description
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.
Time Frame
Change from Baseline to Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Liu, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Saint Mary
City
Leavenworth
State/Province
Kansas
ZIP/Postal Code
66048
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30935324
Citation
Bond BM, Kinslow CD, Yoder AW, Liu W. Effect of spinal manipulative therapy on mechanical pain sensitivity in patients with chronic nonspecific low back pain: a pilot randomized, controlled trial. J Man Manip Ther. 2020 Feb;28(1):15-27. doi: 10.1080/10669817.2019.1572986. Epub 2019 Mar 5.
Results Reference
derived

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Central Mechanism of Manual Therapy for Low Back Pain

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