Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures: a Double-blind Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Quick-DASH functional scale
研究概览
简要总结
Among the various complications of the postoperative evolution of proximal humerus fractures (PHF) are pain and joint stiffness, generating significant functional limitation in the affected limb. This randomized controlled double-blind clinical study aims to evaluate the effects of photobiomodulation (PBM) on the functional recovery of participants with PHF surgically treated with special locking plates. The primary outcome, to be assessed at 1, 2, 4, 8, and 12 weeks, will be shoulder function recovery using the Quick-DASH functional scale. Secondary outcomes will include shoulder range of motion assessments with a digital goniometer, quality of life measured using the SF-6 questionnaire, and the occurrence of adverse effects during all experimental periods. Pain will be evaluated at 1, 2, 4, 8, and 12 weeks; fracture consolidation will be assessed through radiographic examinations at 4, 8, and 12 weeks; and muscular strength will be evaluated through progressive weight-bearing exercises at 8 and 12 weeks. Data will be presented as means ± SD, with significance set at a p-value of 0.05.
详细描述
Among the complications of postoperative recovery from proximal humerus fractures (PHF) are pain and joint stiffness, which can significantly limit limb function. Physical therapy is standard for both surgical and non-surgical treatments. Research suggests that photobiomodulation (PBM) positively affects fracture repair, regeneration, analgesia, and functional improvement, but more standardization and evidence are needed. This double-blind, randomized controlled study aims to assess PBM's impact on functional recovery in patients with surgically treated PHF using specialized locking plates. Forty-two participants will be randomly assigned (1:1) to either the Control group (standard physiotherapy with simulated PBM) or the FBM group (standard physiotherapy with active PBM). The PBM will be administered at home daily for 10 minutes using a device with 318 LEDs: 159 at 660 nm (28.5 mW; 12 J/cm²; 17 J per LED) and 159 at 850 nm (23 mW; 10 J/cm²; 14 J per LED). PBM and physiotherapy sessions (30 minutes, twice a week) will continue for 12 weeks. Participants and examiners will be blinded to group allocation. The primary outcome is shoulder function recovery, measured by the Quick-DASH scale, that will be evaluated 1, 2, 4, 8, and 12 weeks after surgery . Secondary outcomes include shoulder range of motion (digital goniometer), quality of life (SF-6 questionnaire), and adverse effects. The intensity of spontaneous pain and pain during movement of the injured limb will be assessed using the visual analog scale for pain. Pressure pain at the fracture site will be evaluated with a digital algometer (MED DOR, Governador Valadares, MG, Brazil) at 1, 2, 4, 8, and 12 weeks. Fracture consolidation via radiographs at 4, 8, and 12 weeks, and muscle strength through progressive weight bearing at 8 and 12 weeks. Data will be stored, organized, and analyzed using appropriate statistical tests, with a significance level set at 5%.
Keywords: Photobiomodulation, Humerus Fracture, Quick-DASH, Quality of life, Phototherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
1 Researcher, who will prepare the randomization and envelopes to ensure allocation concealment.
1 Researcher (resident physician) who will include subjects, open the envelope with the allocation, deliver the appropriate PBM device, and provide instructions.
4 Surgeons all surgical procedures and eligibility assessments. 4 Orthopedic physician evaluators (blinded to the experimental group of each participant), responsible for all evaluations from the postoperative period through outpatient follow-up.
- The Principal Investigator will be aware of the groups; he will centralize data collection and will not participate in any evaluations.
1 Physical Therapist (blinded to the experimental group of each participant) 3 resident Physicians (blinded to each participant's experimental group) will contact participants daily
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Quick-DASH functional scale
时间窗: The QuickDASH will be applied at 12 weeks after the surgical procedure.
In this project, the dysfunction and symptom component of the QuickDASH score, validated for Brazil and available online, will be used. The QuickDASH score is calculated as follows: At least 10 out of the 11 items must be answered. Each answered question will have a maximum value of 5. These values are then transformed into a score of 100 by subtracting 1 and multiplying by 25. This transformation is done to compare the scores with other scales ranging from 0 to 100. A high score indicates significant dysfunction. QuickDASH Score = \[(Sum of responses / n) - 1\] X 25 n: the number of questions answered.
次要结局
- Range of Motion(Range of motion will be assessed after 12 weeks of the surgical procedure)
- Pain Assessment(It will be evaluated at 12 weeks of the surgical procedure)
- SF-6 instrument(It will be evaluated at 12 weeks after surgical procedure)
- Muscle Strength(12th week of the surgical procedure)
- Analgesic Consumption(It will be evaluated during a period of 12 weeks after surgical procedure)
- Fracture Healing(It will be evaluated 12 weeks after surgical procedure)
- Procedure-Related Costs(It will be evaluated during a period of 12 weeks after surgical procedure)
- Occurrence of Adverse Events(It will be evaluated during a period of 12 weeks after surgical procedure)
研究者
Kristianne Porta Santos Fernandes
Principal Invertigator
University of Nove de Julho