Effects of Pompage Associated or Not With Photobiomodulation on Pain, Range of Motion, and Quality of Life in Patients With Neck Pain: a Controlled, Randomized, and Double Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain baseline
研究概览
简要总结
The aim of this study is to evaluate the effects of Pompage associated or not with PBM, using a cluster of LEDs, on pain and neck disability. This controlled, randomized, and double-blinded clinical study includes participants of both genders, aged 18 to 55, with non-specific chronic neck pain will be included. Participants will be randomized into two groups: (1) Pompage (n=28) focusing only on manual therapy through Pompage technique and (2) Pompage + PBM Group (n=28) involving the same procedures as the first group, followed by PBM with a LED cluster applied for 10 minutes to the neck region for 10 sessions. Pain and functional disability will be assessed using the visual analog scale (VAS) and Neck Pain Disability Index before and after the intervention. The resulting data will be submitted to statistical analysis considering α=0.05.
详细描述
Chronic neck pain is a persistent condition affecting the spinal region, resulting in pain and restricted mobility. The management of neck pain often involves manual therapies, encompassing both passive and active interventions, aimed at alleviating pain, enhancing function, improving mobility, motor control, and reducing inflammatory processes. This pain can persist for at least three months and is considered non-specific when it is not associated with any specific underlying condition, such as inflammatory rheumatic disease, osteoporosis, cancer, or radiculopathy.
The use of lasers and LEDs for photobiomodulation (PBM) represents an advantageous approach to treating neck pain, given their demonstrated therapeutic efficacy in the literature. Moreover, these resources are non-invasive and easy to apply, making them an attractive option for both patients and healthcare professionals. Therefore, the aim of this study is to evaluate the effects of Pompage associated or not with PBM, using a cluster of LEDs, on pain and neck disability. This controlled, randomized, and double-blinded clinical study includes participants of both genders, aged 18 to 62, with non-specific chronic neck pain will be included. Participants will be randomized into two groups: (1) Pompage (n=28) focusing only on manual therapy through Pompage technique and (2) Pompage + PBM Group (n=28) involving the same procedures as the first group, followed by PBM with a LED cluster applied for 10 minutes to the neck region. The treatment protocol consists of 10 sessions, three times weekly, excluding weekends. For PBM, a cluster comprising 264 LEDs (8 mW; 4.89J; 9.6 J/cm2; 16 mW/cm² per LED) will be used, with 132 red (660nm) and 132 infrared (850nm) LEDs. Pain and functional disability will be assessed using the visual analog scale (VAS) and Neck Pain Disability Index before and after the intervention. The resulting data will be submitted to statistical analysis considering α=0.05.
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
The study will be conducted by a team of researchers, including one researcher who will supervise the interventions, i.e., the application of pompages associated or not with PBM using LED clusters. This researcher will be the only one to know the intervention performed on each participant. Another researcher will conduct the initial assessment of outcomes and reevaluations (blinded to the experimental and control groups). The statistical analysis will also be performed blindly by a statistician who will receive the data without identification of the group. The patient will be blinded to the treatment with PBM (or its simulation).
入排标准
- 年龄范围
- 18 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 62 years;
- •Both genders;
- •Without comorbidities.
排除标准
- •Presentation of rheumatic or degenerative diseases in the cervical region;
- •Undergoing orthodontic or physiotherapeutic treatment;
- •Initiation of the use of any medication during any phase of the study;
- •Using bite plate.
研究组 & 干预措施
Pompage and photobiomodulation (placebo)
(1) Pompage Group + photobiomodulation placebo (Control): Patients will receive treatment through the application of the pompage technique in the cervical region during 10 sessions performed 3 times per week, excluding weekends.
干预措施: Pompage Technique (manual therapy) (Procedure)
Pompage and photobiomodulation (placebo)
(1) Pompage Group + photobiomodulation placebo (Control): Patients will receive treatment through the application of the pompage technique in the cervical region during 10 sessions performed 3 times per week, excluding weekends.
干预措施: Photobiomodulation (Placebo) (Device)
Pompage + photobiomodulation (Experimental)
(2) Pompage + photobiomodulation (PBM) Group (Experimental): Treatment will consist of 10 sessions in which the pompage technique will be applied associated with photobiomodulation in the form of LED cluster in the cervical region, performed 3 times per week, excluding weekends.
干预措施: Photobiomodulation (Experimental) (Device)
Pompage + photobiomodulation (Experimental)
(2) Pompage + photobiomodulation (PBM) Group (Experimental): Treatment will consist of 10 sessions in which the pompage technique will be applied associated with photobiomodulation in the form of LED cluster in the cervical region, performed 3 times per week, excluding weekends.
干预措施: Pompage Technique (manual therapy) (Procedure)
结局指标
主要结局
Pain baseline
时间窗: Baseline
The Visual Analog Scale (VAS) consists of a visual graduated scale from 0 to 10 cm, where 0 represents the absence of pain and 10 represents very intense pain, used to measure the pain experienced by the patient. This scale will be used for assessment and to monitor treatment progression. The patient is asked about the intensity of their pain, and the corresponding number on the scale is marked.
Pain at the end
时间窗: At the 50th day of the protocol (at the end of Session 10)
The Visual Analog Scale (VAS) consists of a visual graduated scale from 0 to 10 cm, where 0 represents the absence of pain and 10 represents very intense pain, used to measure the pain experienced by the patient. This scale will be used for assessment and to monitor treatment progression. The patient is asked about the intensity of their pain, and the corresponding number on the scale is marked.
次要结局
- Quality of Life at baseline(Baseline)
- Cervical Range of Motion at the end(At the 50th day of the protocol (at the end of Session 10))
- Quality of Life at the end(At the 50th day of the protocol (at the end of Session 10))
- Degree of Functional Disability at the end(At the 50th day of the protocol (at the end of Session 10))
- Degree of Functional Disability at the baseline(Baseline)
- Cervical Range of Motion at baseline(Baseline)
研究者
Anna Carolina Ratto Tempestini Horliana
Principal Investigator
University of Nove de Julho