RCT of Motor Imagery of Extension for LBP vs. Exercise

NCT04394494 | Completed

• 1 other identifier: SAU McKenzie MI
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

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."

Conditions

Low Back Pain

Keywords

Motor Imagery; McKenzie; Low Back Pain; Directional preference

Outcome Measures

Primary Outcomes (4)

• Spine ROM

  range patient is able to bend backward

  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.

  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.

  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.

  within a single, 90 minute session

Study Arms (2)

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.

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.

Other: Control: Physically performing extension based exercises.

Interventions

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.

Motor Imagery

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.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St. Ambrose University: lead

Study Sites (4)

Edward Elmhurst Health Physical Therapy

Naperville, Illinois, 60517, United States

Location

Kevin Farrell

Davenport, Iowa, 52803, United States

Location

Rock Valley Physical Therapy

Davenport, Iowa, 52806, United States

Location

Genesis Physical Therapy - 53rd St

Davenport, Iowa, 52807, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Farrell

  St. Ambrose University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be assigned in an alternating order to either the experimental or control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Orthopaedic Residency Program in Physical Therapy

Model Details: This is an Randomized Control Trial. Subjects with LBP will be allocated to one of 2 study groups.

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: May 25, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 30, 2020
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)