Laterality Training and Pain Drawings

NCT07078084 | Not Yet Recruiting

• 1 other identifier: 5604202539
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Musculoskeletal Pain; Chronic Shoulder Pain; Chronic Knee Pain

Keywords

Chronic musculoskeletal pain; Shoulder pain; Knee pain; Laterality training; Left/right discrimination; Graded motor imagery; Pain neuroscience; Pain drawings

Outcome Measures

Primary Outcomes (1)

• Change in Pain Drawing Area

  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 Outcomes (2)

• Change in Left/Right Judgment Accuracy and Reaction Time

  Baseline and post-intervention (approximately 15 minutes after Baseline)

• Change in Numeric Pain Rating Scale (NPRS)

  Baseline and post-intervention (approximately 15 minutes after Baseline)

Study Arms (2)

Laterality Training Intervention

EXPERIMENTAL

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.

Behavioral: Laterality Training

Sham Cognitive Task Comparator

SHAM 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

Other: Sham (No Treatment)

Interventions

Laterality Training 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.

Also known as: Left/Right Discrimination Task

Laterality Training Intervention

Sham (No Treatment) 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.

Sham Cognitive Task Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hawaii Pacific University: lead
• Therapeutic Neuroscience Research Group: collaborator

Study Sites (2)

Rock Valley Physical Therapy

Moline, Illinois, 61265, United States

Location

Rock Valley Physical Therapy

Davenport, Iowa, 52039, United States

Location

Related Publications (5)

• 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.

  PMID: 17077744 BACKGROUND

• 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.

  PMID: 29568700 BACKGROUND

• 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.

  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.

  PMID: 23158879 BACKGROUND

• 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.

  PMID: 35354678 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adriaan P Louw, PhD

  Therapeutic Neuroscience Research Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriaan P Louw, PhD

CONTACT

816-225-8710; adriaan@eimpt.com

Brett D Neilson, DSc

CONTACT

808-544-0234; bneilson@hpu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 22, 2025
• Study Start: August 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)