Laterality Training and Pain Drawings

NCT ID: NCT07078084

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-02-28

Brief Summary

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The goal of this clinical trial is to learn if laterality training (a type of brain-based therapy) can help reduce pain and change how people with chronic musculoskeletal pain experience and describe their pain. The study will focus on adults with shoulder or knee pain lasting longer than 6 months.

The main questions it aims to answer are:

Does laterality training lead to a reduction in self-reported pain levels?

Does laterality training reduce the area of the body that participants indicate as painful in their pain drawings?

Does laterality training improve accuracy and speed in left/right judgment tasks?

Researchers will compare participants who complete laterality training to those who complete a non-therapeutic cognitive task (a word puzzle) to see if laterality training changes pain drawings and improves pain outcomes.

Participants will:

Complete a pre-intervention assessment including pain ratings, pain drawings, and a left/right judgment test

Be randomly assigned to one of two groups:

Intervention group: Complete 5 one-minute sessions of laterality training using a tablet-based app called Recognise™, identifying left or right hand/foot images depending on the location of their pain

Control group: Complete a 10-minute crossword puzzle activity (non-therapeutic)

Complete the same assessments after the activity (pain ratings, pain drawings, left/right judgment test)

The study will take place at two outpatient physical therapy clinics. Participation involves a single session lasting approximately 30-45 minutes. There is no cost to participate, and no compensation is provided. Participation is voluntary, and all personal data will be kept confidential.

This research will help determine whether laterality training, a non-invasive brain-based technique, can reduce pain and improve quality of life in people with long-standing musculoskeletal pain.

Detailed Description

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Conditions

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Chronic Musculoskeletal Pain Chronic Shoulder Pain Chronic Knee Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study uses a parallel assignment model in which participants are randomly assigned to one of two groups: an intervention group receiving laterality training or a control group completing a non-therapeutic cognitive task. Each participant completes only one condition (no crossover), and pre- and post-intervention outcomes are compared between groups. This design allows researchers to evaluate the specific effects of laterality training on pain and pain-related body mapping.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Laterality Training Intervention

Participants in this arm will complete laterality training using the Recognise™ application. This involves identifying left or right hand or foot images (depending on the participant's pain location) displayed on a tablet. Each participant will complete 5 rounds of 60-second training with 60-second rest intervals between rounds. The activity is designed to engage cortical body maps and promote neuroplastic changes associated with reduced pain perception.

Group Type EXPERIMENTAL

Laterality Training

Intervention Type BEHAVIORAL

Participants complete a structured laterality training session using a tablet-based application that presents images of hands or feet. Depending on their pain location (shoulder or knee), participants identify whether each image shows a left or right body part. The session consists of 5 one-minute training bouts with 60-second rest intervals between each. The task is designed to engage and retrain cortical body maps associated with the painful region, based on principles of graded motor imagery. Participants are instructed to prioritize accuracy over speed.

Sham Cognitive Task Comparator

Participants in this arm will complete a non-therapeutic cognitive activity by working independently on a standard word-based crossword puzzle for 10 minutes. This task is designed to match the duration and engagement level of the laterality training without influencing sensorimotor processing or cortical body maps. It serves as a sham comparator to help isolate the specific effects of the laterality training intervention

Group Type SHAM_COMPARATOR

Sham (No Treatment)

Intervention Type OTHER

Participants in this arm will complete a non-therapeutic cognitive activity by working independently on a standard word-based crossword puzzle for 10 minutes. This task is designed to match the duration and engagement level of the laterality training without influencing sensorimotor processing or cortical body maps. It serves as a sham comparator to help isolate the specific effects of the laterality training intervention.

Interventions

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Laterality Training

Participants complete a structured laterality training session using a tablet-based application that presents images of hands or feet. Depending on their pain location (shoulder or knee), participants identify whether each image shows a left or right body part. The session consists of 5 one-minute training bouts with 60-second rest intervals between each. The task is designed to engage and retrain cortical body maps associated with the painful region, based on principles of graded motor imagery. Participants are instructed to prioritize accuracy over speed.

Intervention Type BEHAVIORAL

Sham (No Treatment)

Participants in this arm will complete a non-therapeutic cognitive activity by working independently on a standard word-based crossword puzzle for 10 minutes. This task is designed to match the duration and engagement level of the laterality training without influencing sensorimotor processing or cortical body maps. It serves as a sham comparator to help isolate the specific effects of the laterality training intervention.

Intervention Type OTHER

Other Intervention Names

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Left/Right Discrimination Task

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 years or older
* Diagnosis of chronic shoulder or knee pain lasting more than 6 months
* Able to read and understand English
* Willing to provide written informed consent

Exclusion Criteria

* Visual impairments that would interfere with laterality training (e.g., blindness or significant difficulty with vision)
* Previous participation in laterality (left/right discrimination) training
* Unwilling or unable to participate in the study procedures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Therapeutic Neuroscience Research Group

NETWORK

Sponsor Role collaborator

Hawaii Pacific University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adriaan P Louw, PhD

Role: PRINCIPAL_INVESTIGATOR

Therapeutic Neuroscience Research Group

Locations

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Rock Valley Physical Therapy

Moline, Illinois, United States

Site Status

Rock Valley Physical Therapy

Davenport, Iowa, United States

Site Status

Countries

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United States

Central Contacts

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Adriaan P Louw, PhD

Role: CONTACT

816-225-8710

Brett D Neilson, DSc

Role: CONTACT

808-544-0234

Facility Contacts

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Chad Humphrey, MPT

Role: primary

(309) 743-2072

Meghan Buchanan, DPT

Role: primary

(563) 324-2263

References

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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.

Reference Type BACKGROUND
PMID: 17077744 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29568700 (View on PubMed)

Louw A, Farrell K, Zimney K, et al. Pain and Decreased Range of Motion in Knees and Shoulders: A Brief Sensory Remapping Intervention. Pain and Rehabilitation. 2017;Summer(43):20-30.

Reference Type BACKGROUND

Bowering KJ, O'Connell NE, Tabor A, Catley MJ, Leake HB, Moseley GL, Stanton TR. The effects of graded motor imagery and its components on chronic pain: a systematic review and meta-analysis. J Pain. 2013 Jan;14(1):3-13. doi: 10.1016/j.jpain.2012.09.007. Epub 2012 Nov 15.

Reference Type BACKGROUND
PMID: 23158879 (View on PubMed)

Gurudut P, Godse AN. Effectiveness of graded motor imagery in subjects with frozen shoulder: a pilot randomized controlled trial. Korean J Pain. 2022 Apr 1;35(2):152-159. doi: 10.3344/kjp.2022.35.2.152.

Reference Type BACKGROUND
PMID: 35354678 (View on PubMed)

Other Identifiers

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5604202539

Identifier Type: -

Identifier Source: org_study_id

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