Home-Based Photobiomodulation Effects in the Postoperative Period of Distal Radius Fractures

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Nove de Julho

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged 18 to 65 years,

Both sexes,

Patients with isolated, closed distal radius fractures with displacement and surgical indication,

Dorsal tilt of the distal fragment >20°,

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Open reduction and internal fixation (ORIF) with locked volar plate

    Procedure/Surgery

    All participants will undergo open reduction and internal fixation (ORIF) with a locked volar plate, without postoperative immobilization.

  • Home exercises

    Procedure/Surgery

    Unsupervised protocol twice daily for 12 weeks, starting 24 hours post-surgery

  • Active photobiomodulation

    Device

    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 photobiomodulation

    Device

    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.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Active photobiomodulationActive comparator 3 interventions
Group B: Inactive photobiomodulationSham comparator 3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
up to 2 weeks

Secondary outcomes

1

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

Time frame
up to 4 weeks
2

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

Time frame
up to 6 weeks
3

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

Time frame
up to 12 weeks
4

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.

Time frame
up to 24 hours

Other outcomes

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