Evaluating the Clinical Effectiveness of Adjunct Low-level Laser Therapy (ECEALT) in the Management of Chronic Low-Back Pain: A Long-Term, Double-Blind, Randomized Control Trial in Physiotherapy Clinics in Ontario, Canada
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Change in Pain using the Quadruple Visual Analog Scale
研究概览
简要总结
The primary objective of this double-blind randomized control trial (RCT) is to evaluate the clinical effectiveness of LLLT as adjunctive therapy to standard exercise treatment in patients with non-specific chronic LBP. Specifically, the study will aim to evaluate the effectiveness of adjunct LLLT in the reduction of pain in patients as well as determine its long-term functional outcomes.
详细描述
Low back pain (LBP) is one of the most common musculoskeletal disorders and the leading cause of years lived with disability worldwide with significant socioeconomic impacts. Around 10-15 % of LBP patients develop chronic symptoms lasting more than 3 months, and this is considered chronic, with the causes often being "non-specific" with no identifiable causes. Despite the availability of medication-based protocols, the management of non-specific chronic LBP (NSCLBP) is an increasing challenge to clinicians and their patients. Adjunctive therapy can play an important role in the treatment of NSCLBP. In recent decades, low-level laser therapy (LLLT) has been widely used to relieve pain caused by different musculoskeletal disorders. Though widely used and reported as a safe, non-invasive treatment with minimal side effects; reported therapeutic outcomes of LLLT are varied and conflicting, due in part to methodological concerns, lack of data and unclear results.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Randomization codes will be generated by a member of the trial team who is not involved in the day-to-day running of the trial, nor will they be involved in future data analysis. Each participant's randomized code will be kept in a sealed envelope to be opened only by the assessor during the first trial visit. The assessor and patients will be blinded to treatment allocation but physiotherapists offering treatment will not be blinded to treatment allocation.
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
- •are 18-65 years with the ability to give informed consent
- •report with non - specific chronic low back pain, which is defined as pain of >3 months duration that occurs in the lumbosacral area of the spine, which may or not have the characteristics of limiting the patient's range of movements, and is not attributable to a recognizable, known pathology (e.g., infection, tumor, osteoporosis, lumbar spine fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome).
- •are experiencing pain measured using the Quadruple Visual Analogue Scale between 4 and 7 at the time of assessment will be included to keep homogeneity of pain.
排除标准
- •are under 18 years, and those over 65 years of age
- •have had past fractures of the bone structures of the spine
- •have had previous surgery of the spine
- •have a history of previous surgery of the spine or vertebra; spondylosis, spinal stenosis, lumbar disc herniation
- •use pacemakers (cardiac or brain)
- •are pregnant, or those who plan to become pregnant during the course of the study
- •have acute and/or chronic cardiovascular diseases
- •have dermatological conditions in the area of irradiation and/or inflammatory skin lesions
- •have tattoo/tattoos around the area of irradiation
- •have any sensory deficits as defined by the World Health Organization's working definition
- •are sensitive/allergic to phototherapy
- •have neurological disorders as defined by the World Health Organization's working definition
- •are taking anti-inflammatories or analgesic or psychotropic medications
- •have any current infections
- •have a history of drug abuse, either recreational, over the counter or prescription over the last 3 months
结局指标
主要结局
Change in Pain using the Quadruple Visual Analog Scale
时间窗: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
The change in Pain measured using the Quadruple Visual Analog Scale (QVAS) measured at weeks 1, 2, 3, 6, 8, 12, 26 and 52. Pain reduction measured on a 10-point Likert scale from 0 (no pain) to 10 (worst possible pain). Overall score interpreted based on QVAS scoring manual of \<50(Low intensity) and \>50 (high intensity).
Change in Pain using the McGill Pain Questionnaire
时间窗: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
The change in Pain measured using the McGill Pain Questionnaire measured at weeks 1, 2, 3, 6, 8, 12, 26 and 52. Pain reduction assessed based on an overall score ranging from 0 (would not be seen in a person with true pain) to 78(seen in a person with the greatest pain).
Change in Pain using the Brief Pain Inventory
时间窗: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
The change in Pain measured using the Brief Pain Inventory measured at weeks 6, 8, 12, 26 and 52. Pain reduction assessed based on an overall score ranging from 0 (no pain or does not interfere) to 10(pain as bad as be imagined or completely interferes).
次要结局
- Mean Pain Free Days/Months using the Brief Pain Inventory(Weeks 1, 2, 3, 6, 8, 12, 26 and 52)
- Mean number of days absent from work measured using patients personal daily pain record(Weeks 1, 2, 3, 6, 8, 12, 26 and 52)
- Reliance on medication for pain management using the Brief Pain Inventory(Weeks 1, 2, 3, 6, 8, 12, 26 and 52)
- Fear of Pain measured using the McGill Pain Questionnaire(Weeks 1, 2, 3, 6, 8, 12, 26 and 52)
- Frequency of Low Back Pain Episodes assessed using patients personal daily pain records(Weeks 1, 2, 3, 6, 8, 12, 26 and 52)