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| Name | Class |
|---|---|
| Therapeutic Neuroscience Research Group | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left/Right Judgment Accuracy and Reaction Time | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adriaan P Louw, PhD | Contact | 816-225-8710 | adriaan@eimpt.com | |
| Brett D Neilson, DSc | Contact | 808-544-0234 | bneilson@hpu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Adriaan P Louw, PhD | Therapeutic Neuroscience Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rock Valley Physical Therapy | Moline | Illinois | 61265 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17077744 | Background | 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. | |
| 29568700 | 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. |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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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.
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| 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. |
|
| Change in Numeric Pain Rating Scale (NPRS) | 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) |
| Rock Valley Physical Therapy | Davenport | Iowa | 52039 | United States |
|
| 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. |
| 23158879 | 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. |
| 35354678 | 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. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |