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Chronic PainNCT07285824

Virtual McKenzie Exercises and Centralization of Pain: A Pilot Study

A study testing Motor Imagery-Based Lumbar Extension in people with Chronic Pain and Low Back Pain, run by Evidence In Motion.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Pain, Low Back Pain
What is being tested?
Motor Imagery-Based Lumbar Extension
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Dec 2025to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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.

Read the detailed description

Background and Rationale:

Low back pain (LBP) is the most common musculoskeletal condition treated in outpatient physical therapy, accounting for approximately 25-40% of patient visits. Directional preference, a key element of the McKenzie method, is widely used in the management of LBP. This approach assesses how a patient's symptoms respond to repeated or sustained directional movements-most commonly flexion or extension-and integrates the direction that reduces or centralizes symptoms into the treatment plan. Previous research demonstrates that extension-based directional preference strategies are effective for a large proportion of patients with LBP and are associated with pain reduction, increased mobility, reduced fear of movement, and centralization of radiating symptoms.

In parallel with traditional mechanical assessment and treatment methods, pain neuroscience research has highlighted the role of changes in cortical body maps, particularly in the primary somatosensory cortex (S1), in individuals with LBP. People with persistent LBP exhibit altered S1 representations, including changes in size and organization of cortical maps, which are associated with pain, disability, and functional limitations. These representations are dynamic, and movement-based therapies can help normalize them.

However, patients with high pain levels, significant fear-avoidance, or sensitized nervous systems may find movement-based interventions difficult to perform. Motor imagery-mentally simulating movement without performing it physically-may provide an alternative method for modifying cortical representations while reducing threat and avoiding symptom aggravation. Motor imagery activates neural regions similar to those used during actual movement execution and may be beneficial for individuals reluctant to engage in active movement.

Preliminary findings have suggested that virtual or imagery-based McKenzie extension movements may improve pain, fear-avoidance, catastrophization, and mobility in individuals with LBP. Because centralization of symptoms is a hallmark feature of directional preference-based care, this study aims to further explore whether a brief motor imagery-based extension protocol can influence pain intensity, body pain distribution, psychological constructs, physical measures, and centralization in patients with LBP who demonstrate an extension directional preference.

Study Objectives:

The primary objective of this study is to evaluate the immediate effects of a guided motor imagery extension protocol in patients with LBP who demonstrate a directional preference for extension. The study aims to determine whether the intervention results in changes in pain intensity, disability, fear-avoidance, pain catastrophization, lumbar flexion, straight leg raise, and pain distribution, as well as whether patients report centralization of symptoms.

Study Design:

This study is a single-group, pre-post exploratory design conducted across three outpatient physical therapy clinics. Institutional Review Board approval will be obtained prior to study initiation. Eligible patients presenting with LBP will be identified during their initial evaluation. Participants must be between 18 and 65 years of age, able to read and understand English, present with no red flags during review of systems, have no prior spinal surgery, and demonstrate a positive response to extension-based directional preference testing. Participation is voluntary and requires written informed consent.

Intervention Procedures:

Following consent, participants will complete a demographics questionnaire. A blinded therapist will administer baseline measures including disability, pain intensity, fear-avoidance beliefs, pain catastrophization, active trunk flexion, straight leg raise (SLR), and a pain body chart.

Participants will then receive a brief educational explanation of cortical map changes associated with LBP. Next, participants will assume a prone "pre-press-up" position, placing their hands under their shoulders. Instead of performing an active press-up, they will close their eyes and receive verbal guidance through a series of ten motor imagery-based lumbar extension movements. The standardized script instructs participants to visualize completing a full press-up, experiencing spinal extension, holding briefly at end range, and returning to the starting position. Total intervention time is approximately five minutes.

Immediately following the imagery protocol, a blinded therapist will repeat all outcome measures. After data collection, clinicians will resume their usual plan of care for each patient.

Outcome Measures:

Pre- and post-intervention measures include:

Oswestry Disability Index (ODI) to assess functional disability

Numeric Pain Rating Scale (NPRS) for low back and leg pain

Fear Avoidance Beliefs Questionnaire (FABQ), including Physical Activity and Work subscales

Pain Catastrophization Scale (PCS)

Active lumbar flexion (fingertip-to-floor distance in centimeters)

Straight Leg Raise measured with an inclinometer

Body chart with grid overlay to quantify pain distribution and potential changes in cortical representation

Data Management and Analysis:

De-identified data will be compiled and analyzed using descriptive statistics for demographic variables. Pre- and post-intervention comparisons will be performed using paired-samples t-tests with significance set at p < 0.05. Significant findings will be confirmed with Wilcoxon Signed Ranks nonparametric testing.

Being tested
Motor Imagery-Based Lumbar Extension
Keywords
Low Back Pain, Chronic Pain, Directional Preference, McKenzie Method, Extension-Based Exercise, Motor Imagery, Virtual Exercise, Pain Centralization, Fear-Avoidance, Pain Catastrophization, Physical Therapy, Cortical Representation, Somatosensory Cortex (S1), Body Schema, Disability
Medical subject headings
Chronic Pain, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motor Imagery-Based Lumbar ExtensionBehavioural

    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.

Study groups in NCT07285824
Study groupRoleWhat they receive
Motor Imagery Extension ProtocolExperimentalParticipants 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.
Receives: Behavioral: Motor Imagery-Based Lumbar Extension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Leg Pain Intensity (NPRS - Leg)

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

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

Secondary outcomes (7)
  1. Oswestry Disability Index (ODI)

    Change in disability level measured by the 10-item ODI questionnaire. Scores range from 0-50, multiplied by 2 to produce a percentage (0-100%), with higher scores indicating greater disability.

    Measured: Pre-intervention to immediately post-intervention.

  2. Fear-Avoidance Beliefs Questionnaire (FABQ) - Physical Activity Subscale

    Change in fear-avoidance beliefs related to work. The 7-item FABQ-W yields scores from 0-42, with higher scores indicating greater work-related fear-avoidance.

    Measured: Pre-intervention to immediately post-intervention.

  3. Pain Catastrophization Scale (PCS)

    Change in pain catastrophizing as measured by the 13-item PCS. Total scores range from 0-52, with higher scores indicating greater catastrophic thinking about pain.

    Measured: Pre-intervention to immediately post-intervention.

  4. Active Lumbar Flexion (Fingertip-to-Floor Distance)

    Change in active trunk forward flexion measured in centimeters from the tip of the longest finger of the dominant hand to the floor. Lower values indicate greater lumbar and hamstring mobility.

    Measured: Pre-intervention to immediately post-intervention.

  5. Straight Leg Raise (SLR)

    Change in SLR measured using an inclinometer placed on the tibia. SLR is measured on the most affected leg, with the ankle maintained in neutral. Degrees of hip flexion are recorded.

    Measured: Pre-intervention to immediately post-intervention.

  6. Pain Distribution (Body Chart Grid Count)

    Change in pain distribution measured using a standardized body chart. Pain areas are quantified using a grid overlay, producing a count of regions marked by the participant.

    Measured: Pre-intervention to immediately post-intervention.

  7. Symptom Centralization (Qualitative Report)

    Presence or absence of centralization of symptoms based on patient self-report during or after the motor imagery extension protocol. Centralization is defined as a proximal shift of pain toward the lumbar spine.

    Measured: Immediately post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study startDec 2025 (estimated)
  3. Primary completionMay 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07285824
Sponsor's protocol ID
VirtualMcKenzie2025
Status last verified
Dec 2025
First submitted
3 Dec 2025
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gerhardt A, Eich W, Janke S, Leisner S, Treede RD, Tesarz J. Chronic Widespread Back Pain is Distinct From Chronic Local Back Pain: Evidence From Quantitative Sensory Testing, Pain Drawings, and Psychometrics. Clin J Pain. 2016 Jul;32(7):568-79. doi: 10.1097/AJP.0000000000000300.

    PubMed 26379077
  • Sanders NW, Mann NH 3rd, Spengler DM. Pain drawing scoring is not improved by inclusion of patient-reported pain sensation. Spine (Phila Pa 1976). 2006 Nov 1;31(23):2735-41; discussion 2742-3. doi: 10.1097/01.brs.0000244674.99258.f9.

    PubMed 17077744
  • Lacey RJ, Lewis M, Jordan K, Jinks C, Sim J. Interrater reliability of scoring of pain drawings in a self-report health survey. Spine (Phila Pa 1976). 2005 Aug 15;30(16):E455-8. doi: 10.1097/01.brs.0000174274.38485.ee.

    PubMed 16103839
  • Matthews M, Rathleff MS, Vicenzino B, Boudreau SA. Capturing patient-reported area of knee pain: a concurrent validity study using digital technology in patients with patellofemoral pain. PeerJ. 2018 Mar 8;6:e4406. doi: 10.7717/peerj.4406. eCollection 2018.

    PubMed 29568700
  • Wand BM, Keeves J, Bourgoin C, George PJ, Smith AJ, O'Connell NE, Moseley GL. Mislocalization of sensory information in people with chronic low back pain: a preliminary investigation. Clin J Pain. 2013 Aug;29(8):737-43. doi: 10.1097/AJP.0b013e318274b320.

    PubMed 23835768
  • Ekedahl H, Jonsson B, Frobell RB. Fingertip-to-floor test and straight leg raising test: validity, responsiveness, and predictive value in patients with acute/subacute low back pain. Arch Phys Med Rehabil. 2012 Dec;93(12):2210-5. doi: 10.1016/j.apmr.2012.04.020. Epub 2012 Apr 30.

    PubMed 22555005
  • Zimney K, Louw A, Puentedura EJ. Use of Therapeutic Neuroscience Education to address psychosocial factors associated with acute low back pain: a case report. Physiother Theory Pract. 2014 Apr;30(3):202-9. doi: 10.3109/09593985.2013.856508. Epub 2013 Nov 19.

    PubMed 24252071
  • George SZ, Valencia C, Beneciuk JM. A psychometric investigation of fear-avoidance model measures in patients with chronic low back pain. J Orthop Sports Phys Ther. 2010 Apr;40(4):197-205. doi: 10.2519/jospt.2010.3298.

    PubMed 20357418
  • Moseley GL. Evidence for a direct relationship between cognitive and physical change during an education intervention in people with chronic low back pain. Eur J Pain. 2004 Feb;8(1):39-45. doi: 10.1016/S1090-3801(03)00063-6.

    PubMed 14690673
  • Moseley GL, Nicholas MK, Hodges PW. A randomized controlled trial of intensive neurophysiology education in chronic low back pain. Clin J Pain. 2004 Sep-Oct;20(5):324-30. doi: 10.1097/00002508-200409000-00007.

    PubMed 15322439
  • Burton AK, Waddell G, Tillotson KM, Summerton N. Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care. Spine (Phila Pa 1976). 1999 Dec 1;24(23):2484-91. doi: 10.1097/00007632-199912010-00010.

    PubMed 10626311
  • Fritz JM, George SZ. Identifying psychosocial variables in patients with acute work-related low back pain: the importance of fear-avoidance beliefs. Phys Ther. 2002 Oct;82(10):973-83.

    PubMed 12350212
  • Poiraudeau S, Rannou F, Baron G, Henanff LA, Coudeyre E, Rozenberg S, Huas D, Martineau C, Jolivet-Landreau I, Garcia-Mace J, Revel M, Ravaud P. Fear-avoidance beliefs about back pain in patients with subacute low back pain. Pain. 2006 Oct;124(3):305-311. doi: 10.1016/j.pain.2006.04.019. Epub 2006 Jun 5.

    PubMed 16740362
  • Grotle M, Vollestad NK, Brox JI. Clinical course and impact of fear-avoidance beliefs in low back pain: prospective cohort study of acute and chronic low back pain: II. Spine (Phila Pa 1976). 2006 Apr 20;31(9):1038-46. doi: 10.1097/01.brs.0000214878.01709.0e.

    PubMed 16641782
  • Cleland JA, Fritz JM, Childs JD. Psychometric properties of the Fear-Avoidance Beliefs Questionnaire and Tampa Scale of Kinesiophobia in patients with neck pain. Am J Phys Med Rehabil. 2008 Feb;87(2):109-17. doi: 10.1097/PHM.0b013e31815b61f1.

    PubMed 17993982

Questions about this trial

What is this clinical trial studying?

A study testing Motor Imagery-Based Lumbar Extension in people with Chronic Pain and Low Back Pain, run by Evidence In Motion.

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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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?

Low Back Pain Intensity (NPRS - Low Back) (time frame: Pre-intervention to immediately post-intervention (same session).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07285824, which also lists 56 linked publications.

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 16 Dec 2025.

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