search
Back to results

RCT of Motor Imagery of Extension for LBP vs. Exercise

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motor Imagery. Imaging doing Extension exercises without actually doing them.
Control: Physically performing extension based exercises.
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 Motor Imagery, McKenzie, Low Back Pain, Directional preference

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • LBP of less than 3 months duration
  • Age 18-65
  • Able to read and understand English
  • Fit directional preference of extension

Exclusion Criteria:

  • Any red flags for therapy
  • Prior spinal surgery
  • Directional preference of flexsion

Sites / Locations

  • Edward Elmhurst Health Physical Therapy
  • Kevin Farrell
  • Rock Valley Physical Therapy
  • Genesis Physical Therapy - 53rd St

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motor Imagery

Control

Arm Description

Patients are instructed in a motor imagery protocol of imaging extension exercises (similar to the CG), without doing the actual extension exercises. Patients will be instructed in visualizing them moving into extension and back as well as common sensations they may experience (as if doing the actual exercise). They will repeat the visualization process 10 times while in the clinic, after which they will be instructed in a home program containing the same treatment - every 2 hours, perform 10 visualization exercises.

Patients are instructed in extension exercises and actually, physically doing the actual extension exercises. Patients will physically repeat the extension exercises 10 times while in the clinic, after which they will be instructed in a home program containing the same treatment - every 2 hours, perform 10 exercises.

Outcomes

Primary Outcome Measures

Spine ROM
range patient is able to bend backward
Pain rating
Numeric pain rating Scale 0 - 10 (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.
Fear of Movement
Fear Avoidance Belief Questionnaire (FABQ): The FABQ is a self-report of patients feelings about their fear to move.
Pain Catastrophization
Pain Catastrophization Scale: The PCS is a self-report questionnaire assessing inappropriate coping strategies and catastrophic thinking about pain and injury. on a 13-item, 5-point Likert scale with higher scores indicating elevated levels of catastrophizing.

Secondary Outcome Measures

Full Information

First Posted
May 14, 2020
Last Updated
May 19, 2022
Sponsor
St. Ambrose University
search

1. Study Identification

Unique Protocol Identification Number
NCT04394494
Brief Title
RCT of Motor Imagery of Extension for LBP vs. Exercise
Official Title
A Randomized Clinical Trial of Extension for Low Back Pain: Motor Imagery of Extension Versus Physical Extension Exercises
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 25, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
August 30, 2020 (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

5. Study Description

Brief Summary
Low back pain (LBP) is the most common musculoskeletal condition treated in physical therapy, accounting for an estimated 25-40% of outpatient physical therapy visits. One strategy commonly used for treating LBP is directional preference. Directional preference is the process of examining a patient with LBP's response to a movement direction, i.e., extension, and if it coincides with improvement, the test becomes part of the treatment. Various studies have shown evidence for, and use of directional preference by physical therapists. Specifically for LBP, directional preference usually involves either an extension-bias or flexion-bias, with various studies indication an extension protocol being the most common (estimated > 80% of patients). With extension exercises, a favorable therapeutic effect result in centralization of symptoms (leg pain migrates proximal), improved range of motion (ROM), decreased pain and decreased fear of movement. In recent years there has been an increased interest in various pain neuroscience strategies to help people in pain, including LBP. It is well established that the physical body of a person is represented in the brain by a network of neurons, often referred to as a representation of that particular body part in the brain. This representation refers to the pattern of activity that is evoked when a particular body part is stimulated. The most famous area of the brain associated with representation is the primary somatosensory cortex (S1). These neuronal representations of body parts are dynamically maintained. It has been shown that patients with pain display different S1 representations than people with no pain. The interesting phenomenon associated with cortical restructuring is the fact that the body maps expand or contract, in essence increasing or decreasing the body map representation in the brain. Furthermore, these changes in shape and size of body maps seem to correlate to increased pain and disability. Various studies have shown that physical movement is associated with restoring the cortical maps, which in turn may be associated with a decreased pain experience. In patients with high levels of pain, sensitization of the nervous system and fear of movement, physical movement itself may increase a pain experience. An added therapeutic ability to help restore these cortical maps is motor imagery (visualization). Various studies have shown that motor imagery activate the same areas of the brain as when actually physically moving, thus restoring the altered maps "without moving."
Detailed Description
Patient arrive to physical therapy with low back pain (physician referral or self-referral) Patient complete standard clinic medical and insurance intake forms Based on the intake forms, patients are screened by the physical therapists against the inclusion criteria and if met, asked to participate in the study Upon agreement, a written consent is signed Patients complete research intake forms: Demographic information Age Gender Duration of LBP Location of LBP (body chart with grid allocation) Pain rating (NPRS): Numeric Pain Rating Scale Fear-Avoidance (Physical and Work Subscales) (FABQ) Pain Catastrophization Scale (PCS) Patients undergo a standard physical therapy interview Patients undergo a standard physical therapy examination Patients undergo a directional preference test to determine if they are potentially responsive to extension exercises Once patients are shown to be responsive to extension, they are alternately allocated to receive motor imagery of extension exercises (experimental group; [EG]) or physical extension exercises (control group, [CG]). Prior to the treatment lumbar extension ROM will be measured via a standardized procedure Upon completion of the tests, patients will receive one of two allocated treatments Following the treatment, patients will undergo repeat measures of: Spinal extension ROM Pain rating Fear of movement Pain catastrophization Patients will be asked to return to physical therapy in 2 to 3 days (standard care) Upon return, measurements will be repeated of: Pain rating Fear of movement Pain catastrophization Spinal extension ROM This marks the end of data collection (and study) of the individual patient - Following the tests the patient is treated per the discretion of the therapist as the data collection has been completed

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Motor Imagery, McKenzie, Low Back Pain, Directional preference

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is an Randomized Control Trial. Subjects with LBP will be allocated to one of 2 study groups.
Masking
Participant
Masking Description
Patients will be assigned in an alternating order to either the experimental or control group.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor Imagery
Arm Type
Experimental
Arm Description
Patients are instructed in a motor imagery protocol of imaging extension exercises (similar to the CG), without doing the actual extension exercises. Patients will be instructed in visualizing them moving into extension and back as well as common sensations they may experience (as if doing the actual exercise). They will repeat the visualization process 10 times while in the clinic, after which they will be instructed in a home program containing the same treatment - every 2 hours, perform 10 visualization exercises.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients are instructed in extension exercises and actually, physically doing the actual extension exercises. Patients will physically repeat the extension exercises 10 times while in the clinic, after which they will be instructed in a home program containing the same treatment - every 2 hours, perform 10 exercises.
Intervention Type
Other
Intervention Name(s)
Motor Imagery. Imaging doing Extension exercises without actually doing them.
Intervention Description
This study will compare imagining doing specific extension based exercises for LBP vs. actually performing the exercises. This intervention will be just imaging doing the exercises.
Intervention Type
Other
Intervention Name(s)
Control: Physically performing extension based exercises.
Intervention Description
This study will compare imagining doing specific extension based exercises for LBP vs. actually doing them. This intervention will be actually, physically performing the exercises.
Primary Outcome Measure Information:
Title
Spine ROM
Description
range patient is able to bend backward
Time Frame
within a single, 90 minute session
Title
Pain rating
Description
Numeric pain rating Scale 0 - 10 (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
within a single, 90 minute session
Title
Fear of Movement
Description
Fear Avoidance Belief Questionnaire (FABQ): The FABQ is a self-report of patients feelings about their fear to move.
Time Frame
within a single, 90 minute session
Title
Pain Catastrophization
Description
Pain Catastrophization Scale: The PCS is a self-report questionnaire assessing inappropriate coping strategies and catastrophic thinking about pain and injury. on a 13-item, 5-point Likert scale with higher scores indicating elevated levels of catastrophizing.
Time Frame
within a single, 90 minute session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: LBP of less than 3 months duration Age 18-65 Able to read and understand English Fit directional preference of extension Exclusion Criteria: Any red flags for therapy Prior spinal surgery Directional preference of flexsion
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
Edward Elmhurst Health Physical Therapy
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60517
Country
United States
Facility Name
Kevin Farrell
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
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 - 53rd St
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to share any of individual's data. All data will be coded for data entry and analysis by research team.

Learn more about this trial

RCT of Motor Imagery of Extension for LBP vs. Exercise

We'll reach out to this number within 24 hrs