Chronic Musculoskeletal PainNCT07078084
Laterality Training and Pain Drawings
A study testing Laterality Training in people with Chronic Musculoskeletal Pain and Chronic Shoulder Pain, run by Hawaii Pacific University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Musculoskeletal Pain, Chronic Shoulder Pain, Chronic Knee Pain
- What is being tested?
- Laterality Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Rock Valley Physical Therapy
Davenport, Iowa, 52039
Meghan Buchanan, DPT, (563) 324-2263, mehan.buchanan@rockvalleypt.com
Rock Valley Physical Therapy
Moline, Illinois, 61265
Chad Humphrey, MPT, (309) 743-2072, chad.humphrey@rockvalleypt.com
About this study
Official title: 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:
Read more
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.
- Being tested
- Laterality Training, Sham (No Treatment)
- Keywords
- Chronic musculoskeletal pain, Shoulder pain, Knee pain, Laterality training, Left/right discrimination, Graded motor imagery, Pain neuroscience, Pain drawings
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laterality TrainingBehavioural
Also called Left/Right Discrimination Task
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and post-intervention (approximately 15 minutes after Baseline)
Secondary outcomes (2)
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.
Measured: Baseline and post-intervention (approximately 15 minutes after Baseline)
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.
Measured: Baseline and post-intervention (approximately 15 minutes after Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hawaii Pacific University
- Sponsor type
- University, hospital or other
- Collaborators
- Therapeutic Neuroscience Research Group
- Responsible party
- Sponsor
- Investigators
- Adriaan P Louw, PhD, Principal investigator, Therapeutic Neuroscience Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078084
- Sponsor's protocol ID
- 5604202539
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17077744Matthews 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.
PubMed 29568700Louw 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.
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.
PubMed 23158879Gurudut 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.
PubMed 35354678
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laterality Training and Pain Drawings: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07078084
- Acronym / sponsor ID
- 5604202539
- Keywords
- Chronic musculoskeletal pain, Shoulder pain, Knee pain, Laterality training, Left/right discrimination, Graded motor imagery, Pain neuroscience, Pain drawings
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hawaii Pacific UniversityUniversity, hospital or other
- Collaborators
- Therapeutic Neuroscience Research Group
- Study start
- Aug 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Laterality Training Intervention | Experimental | Behavioral: Laterality TrainingParticipants 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 | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laterality TrainingAlso: Left/Right Discrimination TaskParticipants 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. | Behavioural | Laterality Training Intervention |
| 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. | Other | Sham Cognitive Task Comparator |
Primary outcome
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.
2 secondary outcomes
Change in Left/Right Judgment Accuracy and Reaction Time
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Background: PubMed 17077744Sanders 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.
- Background: PubMed 29568700Matthews 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.
- BackgroundLouw 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: PubMed 23158879Bowering 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.
- Background: PubMed 35354678Gurudut 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adriaan P Louw, PhD principal investigator
Therapeutic Neuroscience Research Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laterality Training in people with Chronic Musculoskeletal Pain and Chronic Shoulder Pain, run by Hawaii Pacific University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adriaan P Louw, PhD (816-225-8710, adriaan@eimpt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Drawing Area (time frame: Baseline and post-intervention (approximately 15 minutes after Baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07078084, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.