Laterality Training and Pain Drawings

July 12, 2025 updated by: Hawaii Pacific University

Laterality Training and Pain Drawings: A Randomized Controlled Trial

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Left/Right Discrimination Task
Sham Comparator: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Drawing Area
Time Frame: Baseline and post-intervention (approximately 15 minutes after Baseline)
Measured using a standardized body chart with a grid overlay. Participants mark areas of perceived pain, and the total number of grid squares marked is quantified to assess changes in spatial pain representation.
Baseline and post-intervention (approximately 15 minutes after Baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Left/Right Judgment Accuracy and Reaction Time
Time Frame: Baseline and post-intervention (approximately 15 minutes after Baseline)
Assessed using the Recognise™ app. Participants complete two 60-second tests identifying left/right images of hands (shoulder pain) or feet (knee pain). Accuracy (%) and average response time (seconds per image) are recorded.
Baseline and post-intervention (approximately 15 minutes after Baseline)
Change in Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline and post-intervention (approximately 15 minutes after Baseline)
Self-reported pain intensity measured using an 11-point numeric scale (0 = no pain, 10 = worst imaginable pain). This outcome assesses the immediate change in pain before and after the intervention.
Baseline and post-intervention (approximately 15 minutes after Baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Adriaan P Louw, PhD, Therapeutic Neuroscience Research Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

July 3, 2025

First Submitted That Met QC Criteria

July 12, 2025

First Posted (Actual)

July 22, 2025

Study Record Updates

Last Update Posted (Actual)

July 22, 2025

Last Update Submitted That Met QC Criteria

July 12, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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