Distal Radius Fracture
Conditions
Keywords
photobiomodulation, distal radius, locked volar plate, early mobility
Brief 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. 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.
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.
Interventions
PROCEDUREOpen reduction and internal fixation (ORIF) with locked volar plate
All participants will undergo open reduction and internal fixation (ORIF) with a locked volar plate, without postoperative immobilization.
PROCEDUREHome exercises
Unsupervised protocol twice daily for 12 weeks, starting 24 hours post-surgery
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.
DEVICEInactive photobiomodulation
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.
Sponsors
University of Nove de Julho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
1.
Intervention model description
This is a parallel study with 2 arms
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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, * 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).
Exclusion criteria
* 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, * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quick-DASH functional scale - 2 weeks | up to 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quick-DASH functional scale - 4 weeks | up to 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 |
| Quick-DASH functional scale - 6 weeks | up to 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 |
| Quick-DASH functional scale - 12 weeks | up to 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 |
| Pain - 24 hours | up to 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. |
| Pain - 2 weeks | up to 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. |
| Pain - 4 weeks | up to 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. |
| Pain - 6 weeks | up to 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. |
| Pain - 12 weeks | up to 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. |
| Analgesic consumption - 2 weeks | up to 2 weeks | Type and dosage of analgesics, as well as daily use or non-use, will be recorded in the participant's control sheet. |
| Analgesic consumption - 4 weeks | up to 4 weeks | Type and dosage of analgesics, as well as daily use or non-use, will be recorded in the participant's control sheet. |
| Analgesic consumption - 6 weeks | up to 6 weeks | Type and dosage of analgesics, as well as daily use or non-use, will be recorded in the participant's control sheet. |
| Analgesic consumption - 12 weeks | up to 12 weeks | Type and dosage of analgesics, as well as daily use or non-use, will be recorded in the participant's control sheet. |
| PRWE-BR Questionnaire - Pain and Disability - 2 weeks | up to 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. |
| PRWE-BR Questionnaire - Pain and Disability - 4 weeks | up to 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. |
| PRWE-BR Questionnaire - Pain and Disability - 6 weeks | up to 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. |
| PRWE-BR Questionnaire - Pain and Disability - 12 weeks | up to 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. |
| Range of Motion -24 hours | up to 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. |
| Range of Motion - 2 weeks | up to 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. |
| Range of Motion - 4 weeks | up to 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.. |
| Range of Motion - 6 weeks | up to 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.. |
| Range of Motion - 12 weeks | up to 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. |
| Grip Strength - 2 weeks | up to 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. |
| Grip Strength - 4 weeks | up to 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. |
| Grip Strength - 6 weeks | up to 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. |
| Grip Strength - 12 weeks | up to 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. |
| Fracture Healing- 4 weeks | up to 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. |
| Fracture Healing- 6 weeks | up to 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. |
| Fracture Healing- 12 weeks | up to 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. |
| Costs Related to Procedures | up to 12 weeks | 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. |
Countries
Brazil
Contacts
CONTACTKristianne PS Fernandes, PhD
STUDY_DIRECTORKristianne PS Fernandes, PhD
University of Nove de Julho
Outcome results
None listed