Laterality Training and Pain Drawings

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07078084
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hawaii Pacific University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Adriaan P Louw, PhD
Principal Investigator Affiliation Therapeutic Neuroscience Research Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Musculoskeletal Pain, Chronic Shoulder Pain, Chronic Knee Pain
Arms & Interventions

Arms

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.

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

Interventions

Behavioral: - 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.

Other: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rock Valley Physical Therapy, Moline, Illinois

Status

Address

Rock Valley Physical Therapy

Moline, Illinois, 61265

Site Contact

Chad Humphrey, MPT

[email protected]

(309) 743-2072

Rock Valley Physical Therapy, Davenport, Iowa

Status

Address

Rock Valley Physical Therapy

Davenport, Iowa, 52039

Site Contact

Meghan Buchanan, DPT

[email protected]

(563) 324-2263