Distal Radius FractureNCT07426926
Home-Based Photobiomodulation Effects in the Postoperative Period of Distal Radius Fractures
A study testing Open reduction and internal fixation (ORIF) with locked volar plate, Home exercises and Active photobiomodulation in people with Distal Radius Fracture, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
This double-blind, randomized controlled clinical trial aims to evaluate the adjuvant effect of home-based photobiomodulation (PBM) therapy on the rehabilitation of surgically treated DRFs combined with an unsupervised home exercise program. A total of 42 participants will be randomly allocated into two groups. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Open reduction and internal fixation (ORIF) with locked volar plate, Home exercises and Active photobiomodulation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Sep 2025to 30 Dec 2027
- Phase
- Interventional
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years,
- Both sexes,
- Patients with isolated, closed distal radius fractures with displacement and surgical indication,
- Surgical indication defined by instability criteria:
- Dorsal tilt of the distal fragment >20°,
- Radial shortening ≥10 mm,
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- Articular incongruity,
- Dorsal comminution,
- Fractures classified as Fernandez types I, II, or III,
- Fractures classified as AO/OTA types 2R3A2, 2R3A3, 2R3B, or 2R3C (except 2R3C3).
Who cannot join
- Previous wrist injuries, sequelae, or motor deficits due to neurological lesions,
- Pathological fractures,
- Ipsilateral fractures in other regions of the limb,
- Neurovascular injury with sensory deficit at the fracture site,
- Local or systemic contraindications to surgery or postoperative recovery,
- History of photosensitivity,
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- Neurological and/or psychiatric disorders,
- Proliferative or infectious skin lesions at the wrist region,
- Pregnancy,
- Surgical complications (neurological or vascular injuries, or fracture line extension) - excluded from analysis but reported.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
ACN Municipal Hospital
São Paulo, 03807-230
Nilton I Takahashi, MD, +55 11 3394-8030
About this study
Official title: Home-Based Photobiomodulation Effects in the Postoperative Period of Distal Radius Fractures: A Double-Blind, Randomized, Controlled Clinical Trial
This double-blind, randomized controlled clinical trial aims to evaluate the adjuvant effect of home-based photobiomodulation (PBM) therapy on the rehabilitation of surgically treated DRFs combined with an unsupervised home exercise program. A total of 42 participants will be randomly allocated into two groups. The Control Group will undergo the standard surgical procedure, perform the prescribed home exercises recommended by the hospital service, and use an inactive LED plate (photobiomodulation device). The PBM Group will follow the same surgical and exercise protocols but will use an active PBM device. Home exercises will begin 24 hours after surgery and should be performed twice daily for a total of 12 weeks. The device will be applied once daily to the wrist for 12 minutes (6 minutes on the dorsal side and 6 minutes on the palmar side). The primary outcome will be functional wrist assessment using the QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) questionnaire at 2 weeks. Secondary outcomes will include wrist range of motion, grip strength, wrist function, and pain (assessed using the PRWE-BR instrument), as well as fracture healing. Assessments will be performed at 2, 4, 6, and 12 weeks post-surgery, except for bone consolidation (assessed starting at week 4) and for pain and range of motion, which will also be evaluated at 24 hours.
Read the detailed description
Distal radius fracture (DRF) is one of the most common fractures in adults. Its treatment can be either conservative or surgical; however, regardless of the treatment method, it is often associated with pain, loss of function and grip strength, joint stiffness, prolonged absence from work, and even loss of fracture reduction. This double-blind, randomized controlled clinical trial aims to evaluate the adjuvant effect of home-based photobiomodulation (PBM) therapy on the rehabilitation of surgically treated DRFs combined with an unsupervised home exercise program. A total of 42 participants will be randomly allocated into two groups (1:1 ratio). The Control Group will undergo the standard surgical procedure, perform the prescribed home exercises recommended by the hospital service, and use an inactive LED plate (photobiomodulation device). The PBM Group will follow the same surgical and exercise protocols but will use an active PBM device. Home exercises will begin 24 hours after surgery and should be performed twice daily for a total of 12 weeks. The LED plate will contain 100 light-emitting diodes, distributed as follows: 18 LEDs at 630 nm (23 mW; 117 J/cm²; 8 J per LED); 18 LEDs at 680 nm (20 mW; 102 J/cm²; 7 J per LED); 32 LEDs at 760 nm (24 mW; 122 J/cm²; 9 J per LED); and 32 LEDs at 830 nm (28 mW; 143 J/cm²; 10 J per LED). The device will be applied once daily to the wrist for 12 minutes (6 minutes on the dorsal side and 6 minutes on the palmar side). The primary outcome will be functional wrist assessment using the QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) questionnaire at two weeks. Secondary outcomes will include wrist range of motion, grip strength, wrist function, and pain (assessed using the PRWE-BR instrument), as well as fracture healing. Participants will be blinded to their group allocation and will be evaluated by four researchers who are also blinded to the allocation. Assessments will be performed at 2, 4, 6, and 12 weeks post-surgery, except for bone consolidation (assessed starting at week 4) and for pain and range of motion, which will also be evaluated at 24 hours. In addition to these scheduled assessments, each participant will be followed up with daily phone contact. All collected data will be stored and organized in a secure repository, and appropriate statistical tests will be applied for each specific analysis. A significance level of 5% will be adopted for all tests.
- Conditions
- Distal Radius Fracture
- Being tested
- Open reduction and internal fixation (ORIF) with locked volar plate, Home exercises, Active photobiomodulation, Inactive photobiomodulation
- Keywords
- photobiomodulation, distal radius, locked volar plate, early mobility
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction and internal fixation (ORIF) with locked volar plateProcedure or surgery
All participants will undergo open reduction and internal fixation (ORIF) with a locked volar plate, without postoperative immobilization.
Home exercisesProcedure or surgery
Unsupervised protocol twice daily for 12 weeks, starting 24 hours post-surgery
Active photobiomodulationDevice
The intervention consists of an active photobiomodulation wrist brace equipped with 100 light-emitting diodes (LEDs), including 18 LEDs at 630 nm delivering 23 mW of power, 117 J/cm², and 8 J per LED; 18 LEDs at 680 nm delivering 20 mW of power, 102 J/cm², and 7 J per LED; 32 LEDs at 760 nm delivering 24 mW of power, 122 J/cm², and 9 J per LED; and 32 LEDs at 830 nm delivering 28 mW of power, 143 J/cm², and 10 J per LED. The device will be applied once daily for a total of 12 minutes, with six minutes directed to the dorsal aspect of the wrist and six minutes to the volar aspect, over a 12-week period.
Inactive photobiomodulationDevice
The intervention consists of an inactive LED wrist plate that is identical in appearance and sound to the active device but contains no active LEDs. It will be applied once daily for 12 minutes, during which the device will emit only activation light and sound, without delivering therapeutic irradiation.
| Study group | Role | What they receive |
|---|---|---|
| Active photobiomodulation | Active comparator | Active photobiomodulation wrist brace containing 100 LEDs
* 18 LEDs at 630 nm (23 mW; 117 J/cm²; 8 J per LED)
* 18 LEDs at 680 nm (20 mW; 102 J/cm²; 7 J per LED)
* 32 LEDs at 760 nm (24 mW; 122 J/cm²; 9 J per LED)
* 32 LEDs at 830 nm (28 mW; 143 J/cm²; 10 J per LED) Receives: Procedure: Open reduction and internal fixation (ORIF) with locked volar plate; Procedure: Home exercises; Device: Active photobiomodulation |
| Inactive photobiomodulation | Sham comparator | Inactive LED wrist plate, identical in appearance and sound but without active LEDs Receives: Procedure: Open reduction and internal fixation (ORIF) with locked volar plate; Procedure: Home exercises; Device: Inactive photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick-DASH functional scale - 2 weeks
In this project, the disability/symptom component of the QuickDASH (Disabilities of the Arm, Shoulder and Hand) score, validated for Brazil and available online (https://dash.iwh.on.ca/sites/dash/public/translations/Scoring_QuickDASH_Portuguese_Brazil.pdf
), will be used as presented in Appendix 2. The calculation of the Disability/Symptom Score will follow the official instructions provided by the developers. At least 10 of the 11 items must be answered, and each item has a maximum value of 5. The total score is then transformed to a 0-100 scale by subtracting 1 from the mean of the responses and multiplying the result by 25, a procedure that allows comparison with other scales standardized on a 0-100 range. In this context, higher scores indicate greater disability, and the QuickDASH score is therefore expressed according to the following formula: [(Sum of responses / n) -1] X 25, where n: number of questions answered
Measured: up to 2 weeks
Secondary outcomes (29)
Quick-DASH functional scale - 4 weeks
In this project, the disability/symptom component of the QuickDASH (Disabilities of the Arm, Shoulder and Hand) score, validated for Brazil and available online (https://dash.iwh.on.ca/sites/dash/public/translations/Scoring_QuickDASH_Portuguese_Brazil.pdf
), will be used as presented in Appendix 2. The calculation of the Disability/Symptom Score will follow the official instructions provided by the developers. At least 10 of the 11 items must be answered, and each item has a maximum value of 5. The total score is then transformed to a 0-100 scale by subtracting 1 from the mean of the responses and multiplying the result by 25, a procedure that allows comparison with other scales standardized on a 0-100 range. In this context, higher scores indicate greater disability, and the QuickDASH score is therefore expressed according to the following formula: [(Sum of responses / n) -1] X 25, where n: number of questions answered
Measured: up to 4 weeks
Quick-DASH functional scale - 6 weeks
In this project, the disability/symptom component of the QuickDASH (Disabilities of the Arm, Shoulder and Hand) score, validated for Brazil and available online (https://dash.iwh.on.ca/sites/dash/public/translations/Scoring_QuickDASH_Portuguese_Brazil.pdf
), will be used as presented in Appendix 2. The calculation of the Disability/Symptom Score will follow the official instructions provided by the developers. At least 10 of the 11 items must be answered, and each item has a maximum value of 5. The total score is then transformed to a 0-100 scale by subtracting 1 from the mean of the responses and multiplying the result by 25, a procedure that allows comparison with other scales standardized on a 0-100 range. In this context, higher scores indicate greater disability, and the QuickDASH score is therefore expressed according to the following formula: [(Sum of responses / n) -1] X 25, where n: number of questions answered
Measured: up to 6 weeks
Quick-DASH functional scale - 12 weeks
In this project, the disability/symptom component of the QuickDASH (Disabilities of the Arm, Shoulder and Hand) score, validated for Brazil and available online (https://dash.iwh.on.ca/sites/dash/public/translations/Scoring_QuickDASH_Portuguese_Brazil.pdf
), will be used as presented in Appendix 2. The calculation of the Disability/Symptom Score will follow the official instructions provided by the developers. At least 10 of the 11 items must be answered, and each item has a maximum value of 5. The total score is then transformed to a 0-100 scale by subtracting 1 from the mean of the responses and multiplying the result by 25, a procedure that allows comparison with other scales standardized on a 0-100 range. In this context, higher scores indicate greater disability, and the QuickDASH score is therefore expressed according to the following formula: [(Sum of responses / n) -1] X 25, where n: number of questions answered
Measured: up to 12 weeks
Pain - 24 hours
Spontaneous pain intensity will be assessed using a 10-cm visual analog scale (VAS) with numerical, color, and facial expression indicators (mild, moderate, severe) to facilitate participant understanding. Pain occurrence will also be recorded during daily monitoring and documented in the participant's control sheet.
Measured: up to 24 hours
Pain - 2 weeks
Spontaneous pain intensity will be assessed using a 10-cm visual analog scale (VAS) with numerical, color, and facial expression indicators (mild, moderate, severe) to facilitate participant understanding. Pain occurrence will also be recorded during daily monitoring and documented in the participant's control sheet.
Measured: up to 2 weeks
Pain - 4 weeks
Spontaneous pain intensity will be assessed using a 10-cm visual analog scale (VAS) with numerical, color, and facial expression indicators (mild, moderate, severe) to facilitate participant understanding. Pain occurrence will also be recorded during daily monitoring and documented in the participant's control sheet.
Measured: up to 4 weeks
Pain - 6 weeks
Spontaneous pain intensity will be assessed using a 10-cm visual analog scale (VAS) with numerical, color, and facial expression indicators (mild, moderate, severe) to facilitate participant understanding. Pain occurrence will also be recorded during daily monitoring and documented in the participant's control sheet.
Measured: up to 6 weeks
Pain - 12 weeks
Spontaneous pain intensity will be assessed using a 10-cm visual analog scale (VAS) with numerical, color, and facial expression indicators (mild, moderate, severe) to facilitate participant understanding. Pain occurrence will also be recorded during daily monitoring and documented in the participant's control sheet.
Measured: up to 12 weeks
Analgesic consumption - 2 weeks
Type and dosage of analgesics, as well as daily use or non-use, will be recorded in the participant's control sheet.
Measured: up to 2 weeks
Analgesic consumption - 4 weeks
Type and dosage of analgesics, as well as daily use or non-use, will be recorded in the participant's control sheet.
Measured: up to 4 weeks
Analgesic consumption - 6 weeks
Type and dosage of analgesics, as well as daily use or non-use, will be recorded in the participant's control sheet.
Measured: up to 6 weeks
Analgesic consumption - 12 weeks
Type and dosage of analgesics, as well as daily use or non-use, will be recorded in the participant's control sheet.
Measured: up to 12 weeks
PRWE-BR Questionnaire - Pain and Disability - 2 weeks
In the PRWE-BR questionnaire, the 15 items are scored from 0 to 10, covering two domains: pain and disability. The pain domain score is obtained by summing the responses to the five corresponding items, whereas the functional domain score is calculated by summing the responses to the ten corresponding items and subsequently dividing the result by two. The total score ranges from 0 to 100, with each domain having a maximum of 50 points. Higher scores indicate greater levels of dysfunction and pain reported by the participant.
Measured: up to 2 weeks
PRWE-BR Questionnaire - Pain and Disability - 4 weeks
In the PRWE-BR questionnaire, the 15 items are scored from 0 to 10, covering two domains: pain and disability. The pain domain score is obtained by summing the responses to the five corresponding items, whereas the functional domain score is calculated by summing the responses to the ten corresponding items and subsequently dividing the result by two. The total score ranges from 0 to 100, with each domain having a maximum of 50 points. Higher scores indicate greater levels of dysfunction and pain reported by the participant.
Measured: up to 4 weeks
PRWE-BR Questionnaire - Pain and Disability - 6 weeks
In the PRWE-BR questionnaire, the 15 items are scored from 0 to 10, covering two domains: pain and disability. The pain domain score is obtained by summing the responses to the five corresponding items, whereas the functional domain score is calculated by summing the responses to the ten corresponding items and subsequently dividing the result by two. The total score ranges from 0 to 100, with each domain having a maximum of 50 points. Higher scores indicate greater levels of dysfunction and pain reported by the participant.
Measured: up to 6 weeks
PRWE-BR Questionnaire - Pain and Disability - 12 weeks
In the PRWE-BR questionnaire, the 15 items are scored from 0 to 10, covering two domains: pain and disability. The pain domain score is obtained by summing the responses to the five corresponding items, whereas the functional domain score is calculated by summing the responses to the ten corresponding items and subsequently dividing the result by two. The total score ranges from 0 to 100, with each domain having a maximum of 50 points. Higher scores indicate greater levels of dysfunction and pain reported by the participant.
Measured: up to 12 weeks
Range of Motion -24 hours
Passive wrist range of motion will be assessed bilaterally using a fleximeter (Sanny, model FL 6010, SBC, São Paulo, Brazil). The evaluator will record the maximum tolerated position for flexion, extension, radial and ulnar deviation, pronation, and supination. For each movement, three measurements will be performed and the mean value will be calculated.
Measured: up to 24 hours
Range of Motion - 2 weeks
Passive wrist range of motion will be assessed bilaterally using a fleximeter (Sanny, model FL 6010, SBC, São Paulo, Brazil). The evaluator will record the maximum tolerated position for flexion, extension, radial and ulnar deviation, pronation, and supination. For each movement, three measurements will be performed and the mean value will be calculated.
Measured: up to 2 weeks
Range of Motion - 4 weeks
Passive wrist range of motion will be assessed bilaterally using a fleximeter (Sanny, model FL 6010, SBC, São Paulo, Brazil). The evaluator will record the maximum tolerated position for flexion, extension, radial and ulnar deviation, pronation, and supination. For each movement, three measurements will be performed and the mean value will be calculated..
Measured: up to 4 weeks
Range of Motion - 6 weeks
Passive wrist range of motion will be assessed bilaterally using a fleximeter (Sanny, model FL 6010, SBC, São Paulo, Brazil). The evaluator will record the maximum tolerated position for flexion, extension, radial and ulnar deviation, pronation, and supination. For each movement, three measurements will be performed and the mean value will be calculated..
Measured: up to 6 weeks
Range of Motion - 12 weeks
Passive wrist range of motion will be assessed bilaterally using a fleximeter (Sanny, model FL 6010, SBC, São Paulo, Brazil). The evaluator will record the maximum tolerated position for flexion, extension, radial and ulnar deviation, pronation, and supination. For each movement, three measurements will be performed and the mean value will be calculated.
Measured: up to 12 weeks
Grip Strength - 2 weeks
Grip strength will be assessed using a digital dynamometer (Instrutherm, model DM-90, São Paulo, Brazil). Participants will be seated with elbows flexed at 90°, forearms neutral, and wrists in slight extension. Three measurements will be performed per limb at each session, alternating between injured and uninjured sides, with a 30-second rest. If the third attempt is the highest, further trials will be added until values decrease. The mean of the three highest values per limb will be recorded as grip strength. For right-dominant limbs, a 10% adjustment will be applied.
Measured: up to 12 weeks
Grip Strength - 4 weeks
Grip strength will be assessed using a digital dynamometer (Instrutherm, model DM-90, São Paulo, Brazil). Participants will be seated with elbows flexed at 90°, forearms neutral, and wrists in slight extension. Three measurements will be performed per limb at each session, alternating between injured and uninjured sides, with a 30-second rest. If the third attempt is the highest, further trials will be added until values decrease. The mean of the three highest values per limb will be recorded as grip strength. For right-dominant limbs, a 10% adjustment will be applied.
Measured: up to 4 weeks
Grip Strength - 6 weeks
Grip strength will be assessed using a digital dynamometer (Instrutherm, model DM-90, São Paulo, Brazil). Participants will be seated with elbows flexed at 90°, forearms neutral, and wrists in slight extension. Three measurements will be performed per limb at each session, alternating between injured and uninjured sides, with a 30-second rest. If the third attempt is the highest, further trials will be added until values decrease. The mean of the three highest values per limb will be recorded as grip strength. For right-dominant limbs, a 10% adjustment will be applied.
Measured: up to 6 weeks
Grip Strength - 12 weeks
Grip strength will be assessed using a digital dynamometer (Instrutherm, model DM-90, São Paulo, Brazil). Participants will be seated with elbows flexed at 90°, forearms neutral, and wrists in slight extension. Three measurements will be performed per limb at each session, alternating between injured and uninjured sides, with a 30-second rest. If the third attempt is the highest, further trials will be added until values decrease. The mean of the three highest values per limb will be recorded as grip strength. For right-dominant limbs, a 10% adjustment will be applied.
Measured: up to 12 weeks
Fracture Healing- 4 weeks
Wrist radiographs in posteroanterior, lateral, and oblique views will be obtained at 4, 6, and 12 weeks to assess bone healing, defined as the presence of callus formation bridging three of the four cortices and uniting the main fracture fragments, compared with the immediate postoperative radiograph. At the end of each follow-up visit, participants will receive written instructions regarding the care to be taken in each phase of treatment, along with the date of the next appointment.
Measured: up to 4 weeks
Fracture Healing- 6 weeks
Wrist radiographs in posteroanterior, lateral, and oblique views will be obtained at 4, 6, and 12 weeks to assess bone healing, defined as the presence of callus formation bridging three of the four cortices and uniting the main fracture fragments, compared with the immediate postoperative radiograph. At the end of each follow-up visit, participants will receive written instructions regarding the care to be taken in each phase of treatment, along with the date of the next appointment.
Measured: up to 6 weeks
Fracture Healing- 12 weeks
Wrist radiographs in posteroanterior, lateral, and oblique views will be obtained at 4, 6, and 12 weeks to assess bone healing, defined as the presence of callus formation bridging three of the four cortices and uniting the main fracture fragments, compared with the immediate postoperative radiograph. At the end of each follow-up visit, participants will receive written instructions regarding the care to be taken in each phase of treatment, along with the date of the next appointment.
Measured: up to 12 weeks
Costs Related to Procedures
The costs will be assessed from the perspective of the Brazilian Unified Health System (Sistema Único de Saúde - SUS) as the purchaser of services. Direct costs of the procedures performed during the study period will be considered, including the value of materials used, professional fees, hospital costs, and costs associated with productivity loss due to time away from work. The sources of cost data in Brazilian currency (Real) will include the ComprasNet database, SIGTAP, and the Price Bank of the Ministry of Health.
The final analysis of cost-effectiveness and incremental cost will follow the Methodological Guidelines: Economic Evaluation Studies of Health Technologies and the National Policy on Health Technology Management.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start6 Sep 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies 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 is a parallel study with 2 arms
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristianne Porta Santos Fernandes, University of Nove de Julho
- Investigators
- Kristianne PS Fernandes, PhD, Study director, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426926
- Sponsor's protocol ID
- 6.809.544
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: • The collected data will be stored and organized in a repository and appropriate statistical tests will be applied to specific analyses.