Effects of High-Intensity Laser Therapy and Stretching Exercises on Chronic Non-Specific Neck Pain: Findings From a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Pain intensity at rest (numeric pain rating scale, NPRS)
研究概览
简要总结
Chronic non-specific neck pain (CNNP) poses a significant challenge in healthcare, sparking interest in conservative and innovative therapeutic options such as high-intensity laser therapy (HILT). While evidence of its efficacy in this specific context remains limited, there is a robust foundation supporting the use of HILT in managing chronic neck pain, demonstrating effectiveness in pain reduction and functional improvement. Therefore, the aim of this study is to evaluate the clinical response to HILT treatment in patients with CNNP, investigating its potential therapeutic benefits and adverse effects. The findings of this study will provide valuable insights into the clinical experience with HILT in this population, serving as a pivotal starting point for future research in this field.
In a clinical trial, patients with CNNP will undergo a treatment regimen consisting of two weekly sessions of HILT and stretching exercises over four weeks. The study aims to assess primary outcomes such as resting pain intensity (RPI), movement pain intensity (MPI), and pain pressure threshold (PPT), measured using the numerical pain rating scale and algometry. Secondary outcomes will include cervical range of motion (CROM) and neck disability, assessed through inclinometry and the Neck Disability Index (NDI). Evaluations will occur post-treatment, with a follow-up assessment scheduled one month later.
详细描述
1.1 Study Type and Design: Experimental design for a non-controlled clinical trial.The study will be conducted in the Electrophysical Agents Laboratory (KIN 401) at the School of Physical Therapy, Faculty of Rehabilitation Sciences, Casona de las Condes Campus, Universidad Andrés Bello, located at Calle Fernández Concha Nº700, Las Condes, Santiago, Chile. The sample will be selected from the university population of the same faculty. The study group will be determined through a non-probabilistic sampling process. Participants will be recruited via a closed-ended questionnaire constructed according to selection criteria. The minimum number of participants required for the study will be calculated using the G-Power program, with a minimum of 20 participants. Subjects with CNNP pain will be recruited and will receive 8 sessions of HILT and stretching exercises over 4 weeks. Relevant outcomes will include resting pain intensity (RPI), movement pain intensity (MPI), and pressure pain threshold (PPT). Additionally, cervical range of motion (CROM) and neck disability (ND) will be assessed. Evaluations will be conducted at three time points: before treatment, at the end of treatment, and at a one-month follow-up evaluation.
1.2 Overall Objective To evaluate the effect of high-intensity laser therapy on reducing pain, increasing pain pressure threshold, improving cervical range of motion, and decreasing cervical disability in patients with non-specific chronic neck pain.
1.3 Specific Objectives - Determine the difference in cervical pain intensity before and after high-intensity laser therapy treatment.
- Assess the change in cervical pain pressure threshold before and after treatment with high-intensity laser therapy.
- Measure improvement in cervical range of motion in terms of flexion, extension, rotation, and lateral bending following high-intensity laser therapy.
- Evaluate the reduction in cervical disability using the cervical disability index before and after treatment with high-intensity laser therapy.
- Investigate the correlation between pain reduction, pain pressure threshold, improvement in range of motion, and reduction in cervical disability in response to high-intensity laser therapy.
1.4 Phases of the clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Both sexes
- •Experiencing chronic neck pain: Defined as pain or discomfort in the cervical region between the upper nuchal line and the T1 spinous process or the shoulder girdle. Lasting at least three months
- •Neck Disability Index (NDI) score of 5 or higher
- •Pain intensity of at least three on the Numerical Pain Rating Scale (NPRS) at rest
排除标准
- •Any musculoskeletal injuries sustained in the neck or shoulders within the past three months
- •The presence of osteosynthesis materials in the vicinity of the shoulders, neck, or surrounding areas
- •The existence of skin wounds or changes, such as psoriasis, scars, or burns, in the neck or shoulder region.
- •Continuous usage of analgesic medication, anti-inflammatories, or muscle relaxants.
- •Neurological disorders, which include paresthesias, partial or total loss of sensation, decreased strength, and color changes in the neck, arms, forearms, or hands.
- •Diagnosis of photosensitivity
- •Skin types V and VI, as determined by the Fitzpatrick scale
- •Solar urticaria or adverse reactions to sunlight are present.
- •Diagnosis of autoimmune diseases (e.g., dermatomyositis, systemic lupus erythematosus, hepatic porphyria, carcinoid syndrome, pellagra)
- •Diagnosis of cancer or tumors within the past five years
结局指标
主要结局
Pain intensity at rest (numeric pain rating scale, NPRS)
时间窗: Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up)
Magnitude of neck pain reported by participants at rest. The pain intensity at rest will be measured with the numeric pain rating scale (NPRS). The scale quantifies pain from 0 to 10, where 0 represents the absence of pain and 10 represents the maximum tolerable pain.
Pain intensity at movement (numeric pain rating scale, NPRS)
时间窗: Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up)
Magnitude of pain reported by participants during active cervical movements, including flexion, extension, lateral bending, and rotation. The pain intensity during movement will be measured with the numeric pain rating scale (NPRS).The scale quantifies pain from 0 to 10, where 0 represents the absence of pain and 10 represents the maximum tolerable pain.
Pain pressure threshold (algometry)
时间窗: Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up)
The maximum mechanical pressure tolerated by the patient was assessed using algometry. Six bilateral points were evaluated: 2 cm lateral to the spinous processes of C2, C5, T4, and T8; the midpoint of the upper trapezius muscle (between C7 and the acromion); the levator scapulae (2 cm superior to the superior angle of the scapula); and the middle third of the right tibialis anterior muscle. The pain pressure threshold will be evaluated with pressure algometry (FPX Wagner (R) equipment). The pain pressure threshold measurement unit will be evaluated in pounds per square centimeter.
次要结局
- Cervical range of movement (inclinometer)(Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up))
- Neck disability (neck disability index)(Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up))