Additional Effects Of The Association Of The Photobiomodulation Therapy (904 Nm) With Exercise In Participants With Chronic Non-Specific Low Back Pain In The Long Term
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 主要终点
- Change Of Pain intensity at 3 months post-intervention
研究概览
简要总结
The objective of this clinical trial is to evaluate the additional effects of Laser Therapy in participants with chronic non-specific low back pain in the short and long term.
详细描述
The objective of this clinical trial is to evaluate the additional effects of Photobiomodulation Therapy in participants with chronic non-specifc low back pain in the short and long term.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Patients with non-specific chronic LBP, defined as pain or discomfort between the costal margins and inferior gluteal folds with or without referred pain to the lower limbs;
- •Persistent LBP for at least 3 months;
- •Low back pain of intensity reported 3 or higher by the Visual Analogue Scale (VAS), at least once in the previous 7 days;
- •Aged between 18 and 65 years;
- •Both genders.
排除标准
- •Patients with severe skin diseases (eg, skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);
- •Participants with known or suspected serious spinal pathology (e.g., fractures, tumors, inflammatory, rheumatologic disorders, or infective diseases of the spine);
- •Nerve root compromise;
- •History of previous spinal surgery (even in a segment other than the lumbar spine) or scheduled surgery;
- •Pain due to or associated with pregnancy or structural deformity (for example, scoliosis);
- •Pregnancy;
- •Comorbid health conditions that could prevent active participation in the exercise programs such as high blood pressure, pregnancy, or cardio-respiratory illnesses;
- •Having answered "yes" to any of the questions in the Physical Activity Readiness Questionnaire (PAR-Q);
- •Be treated with PBMT;
- •Being under physiotherapeutic treatment or perform physical exercise;
- •Who are using NSAID or start it during the trial;
- •Who have inability to tolerate the proposed experimental procedures (such as tests of mobility and strength of the lumbar muscles).
结局指标
主要结局
Change Of Pain intensity at 3 months post-intervention
时间窗: Baseline; 3 months after the last intervention
Measured by the Visual Analogue Scale (VAS). The VAS evaluates pain intensity levels perceived by the patient on an 11-point scale ranging from 0 to 10, with 0 being 'no pain' and 10 'the worst possible pain'.
Change Of Pain intensity at post-intervention
时间窗: Baseline; Immediately after the last intervention
Measured by the Visual Analogue Scale (VAS). The VAS evaluates pain intensity levels perceived by the patient on an 11-point scale ranging from 0 to 10, with 0 being 'no pain' and 10 'the worst possible pain'.
Change of Disability associated with low back pain at post-intervention
时间窗: Baseline; Immediately after the last intervention
Measured by the Roland-Morris Disability Questionnaire. The questionnaire consists of 24 items that describe situations that patients may have difficulty performing on a daily basis due to LBP. The greater the number of affirmative answers is, the higher the level of functional disability associated with LBP.
Change of Disability associated with low back pain at 3 months post-intervention
时间窗: Baseline; 3 months after the last intervention
Measured by the Roland-Morris Disability Questionnaire. The questionnaire consists of 24 items that describe situations that patients may have difficulty performing on a daily basis due to LBP. The greater the number of affirmative answers is, the higher the level of functional disability associated with LBP.
次要结局
- Change Of Pain intensity at 12 months post-intervention(Baseline; 12 months after the last intervention)
- Change of Disability associated with low back pain at 12 months post-intervention(Baseline; 12 months after the last intervention)
- Changes os Mental health(Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention)
- Changes of Strength of the trunk extensor muscle(Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention)
- Changes of Disability associated with low back pain(Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention)
- Changes of Mobility of the lumbar and sacral segments(Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention)