NCT07285824

Brief Summary

Low back pain (LBP) is frequently managed in physical therapy using the McKenzie method, in which a patient's directional preference-most commonly extension-is used to guide treatment. Extension-based interventions are associated with symptom improvement and centralization in many individuals with LBP. At the same time, research in pain neuroscience has shown that people with LBP may have altered cortical representations of the low back, which may contribute to pain and disability. For patients who experience high pain levels or significant fear of movement, active directional preference exercises may be difficult to perform. Motor imagery, the mental simulation of movement without physical execution, has been shown to activate brain regions involved in movement and may help modify altered cortical representations. Preliminary research has suggested that virtual or imagery-based McKenzie extension exercises may improve pain and movement-related outcomes. This exploratory study aims to evaluate the immediate effects of a brief motor imagery-based extension protocol in adults with LBP who demonstrate a directional preference for extension. The study will assess changes in pain intensity, disability, fear-avoidance, pain catastrophization, lumbar flexion, straight leg raise, pain distribution, and symptom centralization following a single motor imagery session.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
6mo left

Started Dec 2025

Shorter than P25 for not_applicable chronic-pain

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Dec 2025Nov 2026

Study Start

First participant enrolled

December 1, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 3, 2025

Last Update Submit

December 3, 2025

Conditions

Keywords

Low Back PainChronic PainDirectional PreferenceMcKenzie MethodExtension-Based ExerciseMotor ImageryVirtual ExercisePain CentralizationFear-AvoidancePain CatastrophizationPhysical TherapyCortical RepresentationSomatosensory Cortex (S1)Body SchemaDisability

Outcome Measures

Primary Outcomes (2)

  • Low Back Pain Intensity (NPRS - Low Back)

    Change in self-reported low back pain intensity measured using the 0-10 Numeric Pain Rating Scale (NPRS), where 0 = no pain and 10 = worst imaginable pain.

    Pre-intervention to immediately post-intervention (same session).

  • Leg Pain Intensity (NPRS - Leg)

    Change in self-reported leg pain intensity using the 0-10 NPRS.

    Pre-intervention to immediately post-intervention (same session).

Secondary Outcomes (7)

  • Oswestry Disability Index (ODI)

    Pre-intervention to immediately post-intervention.

  • Fear-Avoidance Beliefs Questionnaire (FABQ) - Physical Activity Subscale

    Pre-intervention to immediately post-intervention.

  • Pain Catastrophization Scale (PCS)

    Pre-intervention to immediately post-intervention.

  • Active Lumbar Flexion (Fingertip-to-Floor Distance)

    Pre-intervention to immediately post-intervention.

  • Straight Leg Raise (SLR)

    Pre-intervention to immediately post-intervention.

  • +2 more secondary outcomes

Study Arms (1)

Motor Imagery Extension Protocol

EXPERIMENTAL

Participants with low back pain who demonstrate a directional preference for extension will receive a single session of a guided motor imagery protocol simulating lumbar extension movements based on the McKenzie method. The intervention is designed to mentally replicate an extension press-up without requiring physical movement.

Behavioral: Motor Imagery-Based Lumbar Extension

Interventions

Participants will lie prone with hands positioned under the shoulders in a standard "pre-press-up" position. With eyes closed, participants will be verbally guided through ten imagined lumbar extension press-ups. The standardized motor imagery script includes: Focusing attention on current back and leg symptoms Imagining pushing the arms into extension Visualizing the back arching into extension Holding the imagined end-range position for several seconds Imagining returning to the starting position in a controlled manner Repeating this process ten times Total duration of the protocol is approximately 5 minutes. Mode of Delivery: In-person, guided by a physical therapist trained in the study protocol. Purpose: To evaluate immediate changes in pain, disability, psychological measures, physical mobility, neurodynamic measures, and symptom centralization following a motor imagery-based extension intervention.

Motor Imagery Extension Protocol

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 65 years
  • Presenting to outpatient physical therapy with low back pain (LBP)
  • Able to read and understand English
  • No red flags identified during review of systems and initial physical therapy evaluation
  • No prior spinal surgery
  • Demonstrates a positive response to extension-based directional preference testing
  • Willing and able to provide written informed consent

You may not qualify if:

  • Age younger than 18 or older than 65
  • Inability to read or understand English
  • Presence of red flags during review of systems (e.g., suspected fracture, malignancy, infection, cauda equina symptoms)
  • History of spinal surgery
  • No demonstrable directional preference for extension during evaluation
  • Any condition that the evaluating clinician determines would preclude safe participation
  • Declines to participate or is unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (56)

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MeSH Terms

Conditions

Chronic PainLow Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2025

First Posted

December 16, 2025

Study Start

December 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

December 16, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share