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Clinical Trials/NCT04394494
NCT04394494
Completed
Not Applicable

A Randomized Clinical Trial of Extension for Low Back Pain: Motor Imagery of Extension Versus Physical Extension Exercises

St. Ambrose University4 sites in 1 country10 target enrollmentMay 25, 2019
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
St. Ambrose University
Enrollment
10
Locations
4
Primary Endpoint
Pain rating
Status
Completed
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
May 25, 2019
End Date
August 30, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kevin Farrell

Professor and Chair, Orthopaedic Residency Program in Physical Therapy

St. Ambrose University

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

Outcomes

Primary Outcomes

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.

Spine ROM

Time Frame: within a single, 90 minute session

range patient is able to bend backward

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.

Study Sites (4)

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