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Manual Therapy as a Form of Sensory Discrimination in Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuroplasticity Explanation (Experimental)
Biomechanical Explanation (Control)
Sponsored by
Kevin Farrell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Pain, Brain, Plasticity, Education, Manual Therapy, Straight Leg Raise, Remapping

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults over the age of 18
  • Presenting at Physical Therapy with a primary complaint of Low Back Pain
  • Low Back Pain being present for 6 months or more
  • Fluent in English and willing to participate in the study.

Exclusion Criteria:

  • Medical precautions to the use of manual therapy (metal, skin lesions, etc.)
  • Prior spine surgery
  • Unable to lay prone for the treatment.

Sites / Locations

  • Rock Valley Physical Therapy
  • Rock Valley Physical Therapy
  • Edward Health & Fitness Center & Spa at Seven Bridges
  • Rock Valley Physical Therapy
  • Genesis Physical Therapy and Sports Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neuroplasticity Education Group

Biomechanical Education Group

Arm Description

Patients who receive manual physical therapy treatment with a neuroplasticity explanation of the basis for the technique

Patients who receive manual physical therapy treatment with a traditional, biomechanical explanation of the basis for the technique

Outcomes

Primary Outcome Measures

Low back pain rating change
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement of the patient's pain in low back on a numeric pain rating scale of 0 to 10
Leg pain rating
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement, level of patient's leg pain on a numeric pain rating scale of 0 to 10.
Active trunk forward flexion
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement of distance from longest finger to the floor when patient bends forward (in cm).
Straight Leg Raise
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement of angle to which the patient's most affected leg can be lifted (measured in degrees using an inclinometer).

Secondary Outcome Measures

Full Information

First Posted
April 12, 2016
Last Updated
April 27, 2016
Sponsor
Kevin Farrell
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1. Study Identification

Unique Protocol Identification Number
NCT02757378
Brief Title
Manual Therapy as a Form of Sensory Discrimination in Chronic Low Back Pain
Official Title
A Randomized Controlled Trial of Manual Therapy as a Form of Sensory Discrimination in Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kevin Farrell

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates whether different explanations given to patients with long lasting back pain influence a physical therapy treatment technique. Half of the patients will receive an explanation of the proposed treatment technique focusing on how their joints are moving and not moving. The second half of the group will receive the same treatment technique as the first group, but their explanation of the technique's purpose will focus on how their brain interprets the information. The study aims to determine if patients have a different response to the treatment based on the words chosen to explain the technique.
Detailed Description
Traditional treatment provided by physical therapists to patients with chronic low back pain focuses on the biomechanical or anatomical impact to local tissues. Recent research has shown that treatment effects may be more related to the understanding of the structural and functional changes in the brain of someone suffering from chronic low back pain. This research implicates that the patients understanding and interpretation of input to the brain may change the patient's perceived representation and interpretation of output of pain within the brain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Pain, Brain, Plasticity, Education, Manual Therapy, Straight Leg Raise, Remapping

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Neuroplasticity Education Group
Arm Type
Experimental
Arm Description
Patients who receive manual physical therapy treatment with a neuroplasticity explanation of the basis for the technique
Arm Title
Biomechanical Education Group
Arm Type
Active Comparator
Arm Description
Patients who receive manual physical therapy treatment with a traditional, biomechanical explanation of the basis for the technique
Intervention Type
Procedure
Intervention Name(s)
Neuroplasticity Explanation (Experimental)
Intervention Description
Patients were given an explanation of how the brain uses the information from a manual therapy technique to help it remain sharp in identifying where this input is coming from.
Intervention Type
Procedure
Intervention Name(s)
Biomechanical Explanation (Control)
Intervention Description
Patients were given an explanation of how the manual therapy technique affects the anatomy and physiology of the back.
Primary Outcome Measure Information:
Title
Low back pain rating change
Description
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement of the patient's pain in low back on a numeric pain rating scale of 0 to 10
Time Frame
Within a single, one hour session
Title
Leg pain rating
Description
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement, level of patient's leg pain on a numeric pain rating scale of 0 to 10.
Time Frame
Within a single, one hour session
Title
Active trunk forward flexion
Description
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement of distance from longest finger to the floor when patient bends forward (in cm).
Time Frame
Within a single, one hour session
Title
Straight Leg Raise
Description
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement of angle to which the patient's most affected leg can be lifted (measured in degrees using an inclinometer).
Time Frame
Within a single, one hour session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults over the age of 18 Presenting at Physical Therapy with a primary complaint of Low Back Pain Low Back Pain being present for 6 months or more Fluent in English and willing to participate in the study. Exclusion Criteria: 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
Adriaan Louw, PT, PhD
Organizational Affiliation
International Spine Pain Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rock Valley Physical Therapy
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Rock Valley Physical Therapy
City
Silvis
State/Province
Illinois
ZIP/Postal Code
61282-4700
Country
United States
Facility Name
Edward Health & Fitness Center & Spa at Seven Bridges
City
Woodridge
State/Province
Illinois
ZIP/Postal Code
60517
Country
United States
Facility Name
Rock Valley Physical Therapy
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52806
Country
United States
Facility Name
Genesis Physical Therapy and Sports Medicine
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Manual Therapy as a Form of Sensory Discrimination in Chronic Low Back Pain

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