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A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain

Primary Purpose

Low Back Pain, Manual Therapy, Education

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual Therapy with Traditional Biomechanical Explanation
Manual Therapy with Neuroplastiicity Explanation
Sponsored by
St. Ambrose University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Manual Therapy, Education, Neuroplasticiy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • adults over the age of 18
  • patients presenting at PT with a primary complaint of LBP
  • LBP being present for 6 months or more
  • fluent in English
  • willing to participate in the study.

Exclusion Criteria:

  • under age 18
  • not able to read/understand the English language
  • prisoners
  • no medical issues precluding physical therapy treatment (red flags)
  • no medical precautions to the use of manual therapy (metal, skin lesions, etc.)
  • prior spine surgery
  • unable to lay prone for the treatment

Sites / Locations

  • Kevin Farrell

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Passive treatment

Active Treatment

Arm Description

Passive treatment will consist of Manual Therapy with biomechanical explanation of the technique.

Active treatment will consist of Manual Therapy with a neuroplasticity explanation of the technique.

Outcomes

Primary Outcome Measures

Low Back Pain Rating
Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0. LBP is reported to be 2.0.
Low Back Pain Rating
Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0.
Lumbar flexion
Active trunk forward flexion in cm (distance finger tips to floor)
Lumbar flexion
Active trunk forward flexion in cm (distance finger tips to floor)
Straight Leg Raise
Neurodynamic Measurement of Leg Raise (lower limb tension test)
Straight Leg Raise
Neurodynamic Measurement of Leg Raise (lower limb tension test)

Secondary Outcome Measures

Full Information

First Posted
November 26, 2018
Last Updated
April 22, 2019
Sponsor
St. Ambrose University
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1. Study Identification

Unique Protocol Identification Number
NCT03758807
Brief Title
A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain
Official Title
A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Ambrose University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine if there is any carry over difference between the type of education provided about common treatment techniques for patients with low back pain. This will be looked at right after treatment and when patients return on their second visit after they do a common exercise program for a few days.
Detailed Description
Prior clinical trials have shown that patients respond differently to different explanations about interventions performed. A recent randomized clinical trial demonstrated that a 10-minute manual therapy treatment (prone lumbar Posterior to Anterior mobilization (PA's) with a neuroplasticity vs. traditional biomechanical explanation) produced an immediate, significant improvement in straight leg raise (SLR) and pain for patients with chronic low back pain. However, there is a need to examine whether there is any carry over (48-96 hours) or if utilizing a home exercise program (HEP), aimed at increasing the various sensory process applied in the clinic, produces any carry over. This will be looked at in patients with who are provided different explanations about common back treatment techniques to see if there will be any change in pain rating or back and leg movement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Manual Therapy, Education
Keywords
Low back pain, Manual Therapy, Education, Neuroplasticiy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Trial
Masking
Participant
Masking Description
Patients were randomly assigned to one of two treatment groups
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Passive treatment
Arm Type
Sham Comparator
Arm Description
Passive treatment will consist of Manual Therapy with biomechanical explanation of the technique.
Arm Title
Active Treatment
Arm Type
Experimental
Arm Description
Active treatment will consist of Manual Therapy with a neuroplasticity explanation of the technique.
Intervention Type
Other
Intervention Name(s)
Manual Therapy with Traditional Biomechanical Explanation
Intervention Description
Patients will lie prone and receive lumbar Posterior to Anterior (AP) Pressure with a traditional biomechanical or anatomic explanation of the technique..
Intervention Type
Other
Intervention Name(s)
Manual Therapy with Neuroplastiicity Explanation
Intervention Description
Patients will lie prone and receive lumbar Posterior to Anterior (PA) Pressure with a neuroplastic explanation of the technique.
Primary Outcome Measure Information:
Title
Low Back Pain Rating
Description
Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0. LBP is reported to be 2.0.
Time Frame
Change from baseline to initial treatment
Title
Low Back Pain Rating
Description
Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0.
Time Frame
Change from initial treatment to 2-4 days
Title
Lumbar flexion
Description
Active trunk forward flexion in cm (distance finger tips to floor)
Time Frame
Change from baseline to initial treatment
Title
Lumbar flexion
Description
Active trunk forward flexion in cm (distance finger tips to floor)
Time Frame
Change from initial treatment to 2-4 days
Title
Straight Leg Raise
Description
Neurodynamic Measurement of Leg Raise (lower limb tension test)
Time Frame
Change from baseline to initial treatment
Title
Straight Leg Raise
Description
Neurodynamic Measurement of Leg Raise (lower limb tension test)
Time Frame
Change from initial treatment to 2-4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adults over the age of 18 patients presenting at PT with a primary complaint of LBP LBP being present for 6 months or more fluent in English willing to participate in the study. Exclusion Criteria: under age 18 not able to read/understand the English language prisoners no medical issues precluding physical therapy treatment (red flags) no medical precautions to the use of manual therapy (metal, skin lesions, etc.) prior spine surgery unable to lay prone for the treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Farrell
Organizational Affiliation
St. Ambrose University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kevin Farrell
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Louw A, Farrell K, Wettach L, Uhl J, Majkowski K, Wedling M. Immediate effects of sensory discrimination for chronic low back pain: a case series. New Zealand Journal of Physiotherapy. 2015;43(2):58-63.
Results Reference
result
PubMed Identifier
29449764
Citation
Louw A, Farrell K, Landers M, Barclay M, Goodman E, Gillund J, McCaffrey S, Timmerman L. The effect of manual therapy and neuroplasticity education on chronic low back pain: a randomized clinical trial. J Man Manip Ther. 2017 Dec;25(5):227-234. doi: 10.1080/10669817.2016.1231860. Epub 2016 Sep 22.
Results Reference
result

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A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain

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