Low Back PainNCT04394494
RCT of Motor Imagery of Extension for LBP vs. Exercise
A study testing Motor Imagery. Imaging doing Extension exercises without actually doing them. in people with Low Back Pain, run by St. Ambrose University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Motor Imagery. Imaging doing Extension exercises without actually doing them.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 May 2019to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- LBP of less than 3 months duration
- Age 18-65
- Able to read and understand English
- Fit directional preference of extension
Who cannot join
- Any red flags for therapy
- Prior spinal surgery
- Directional preference of flexsion
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kevin Farrell
Davenport, Iowa, 52803
Rock Valley Physical Therapy
Davenport, Iowa, 52806
Genesis Physical Therapy - 53rd St
Davenport, Iowa, 52807
Edward Elmhurst Health Physical Therapy
Naperville, Illinois, 60517
About this study
Official title: A Randomized Clinical Trial of Extension for Low Back Pain: Motor Imagery of Extension Versus Physical Extension Exercises
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."
Read the 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
- Conditions
- Low Back Pain
- Being tested
- Motor Imagery. Imaging doing Extension exercises without actually doing them., Control: Physically performing extension based exercises.
- Keywords
- Motor Imagery, McKenzie, Low Back Pain, Directional preference
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Imagery. Imaging doing Extension exercises without actually doing them.Other
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.
Control: Physically performing extension based exercises.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Motor Imagery | Experimental | 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. Receives: Other: Motor Imagery. Imaging doing Extension exercises without actually doing them. |
| Control | Active comparator | 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. Receives: Other: Control: Physically performing extension based exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spine ROM
range patient is able to bend backward
Measured: within a single, 90 minute session
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.
Measured: within a single, 90 minute session
Fear of Movement
Fear Avoidance Belief Questionnaire (FABQ): The FABQ is a self-report of patients feelings about their fear to move.
Measured: within a single, 90 minute session
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.
Measured: within a single, 90 minute session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start25 May 2019
- Primary completion1 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an Randomized Control Trial. Subjects with LBP will be allocated to one of 2 study groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Ambrose University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Farrell, St. Ambrose University
- Investigators
- Kevin Farrell, Principal investigator, St. Ambrose University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394494
- Sponsor's protocol ID
- SAU McKenzie MI
- Status last verified
- May 2022
- First submitted
- 14 May 2020
- Last updated
- 26 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share any of individual's data. All data will be coded for data entry and analysis by research team.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Extension for Low Back Pain: Motor Imagery of Extension Versus Physical Extension Exercises
- ClinicalTrials.gov ID
- NCT04394494
- Acronym / sponsor ID
- SAU McKenzie MI
- Conditions
- Low Back Pain
- Keywords
- Motor Imagery, McKenzie, Low Back Pain, Directional preference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- St. Ambrose UniversityUniversity, hospital or other
- Study start
- 25 May 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is an Randomized Control Trial. Subjects with LBP will be allocated to one of 2 study groups.
| Arm | Type | Receives |
|---|---|---|
| Motor Imagery | Experimental | Other: Motor Imagery. Imaging doing Extension exercises without actually doing them.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. |
| Control | Active comparator | Other: Control: Physically performing extension based 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- LBP of less than 3 months duration
- Age 18-65
- Able to read and understand English
- Fit directional preference of extension
Key exclusion criteria (3 listed)
- Any red flags for therapy
- Prior spinal surgery
- Directional preference of flexsion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor Imagery. Imaging doing Extension exercises without actually doing them.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. | Other | Motor Imagery |
| Control: Physically performing extension based exercises.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. | Other | Control |
Primary outcome
Spine ROM
Time frame: within a single, 90 minute session
range patient is able to bend backward
Pain rating
Time frame: within a single, 90 minute session
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
Time frame: within a single, 90 minute session
Fear Avoidance Belief Questionnaire (FABQ): The FABQ is a self-report of patients feelings about their fear to move.
Pain Catastrophization
Time frame: within a single, 90 minute session
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No. There are no plans to share any of individual's data. All data will be coded for data entry and analysis by research team.
Related trials for Low Back Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Farrell principal investigator
St. Ambrose University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Imagery. Imaging doing Extension exercises without actually doing them. in people with Low Back Pain, run by St. Ambrose University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spine ROM (time frame: within a single, 90 minute session). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.