- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07078084
- Original Trial
Laterality Training and Pain Drawings
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
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Adriaan P Louw, PhD
- Phone Number: 816-225-8710
- Email: adriaan@eimpt.com
Study Contact Backup
- Name: Brett D Neilson, DSc
- Phone Number: 808-544-0234
- Email: bneilson@hpu.edu
Study Locations
-
-
Illinois
-
Moline, Illinois, United States, 61265
- Rock Valley Physical Therapy
-
Contact:
- Chad Humphrey, MPT
- Phone Number: (309) 743-2072
- Email: chad.humphrey@rockvalleypt.com
-
-
Iowa
-
Davenport, Iowa, United States, 52039
- Rock Valley Physical Therapy
-
Contact:
- Meghan Buchanan, DPT
- Phone Number: (563) 324-2263
- Email: mehan.buchanan@rockvalleypt.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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:
|
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Adriaan P Louw, PhD, Therapeutic Neuroscience Research Group
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5604202539
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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