Musculoskeletal Pain/Low Back Pain
Patients will often experience pain in a joint, ligament, tendon, or muscle somewhere in their body and it can restrict their range of motion, flexibility, and ability to sleep. The restriction and pain are often due to inflammation that causes heat, swelling, neurologic pain, and pain referral patterns. Injury can be acute or chronic, and can happen traumatically (such as falling) or repetitively (such as sitting long hours for work and not moving much throughout). Regardless of the mechanism, injury to the tissue occurs.
In the first stages of our body's awareness of pain, there is inflammation and swelling, and our immune system greatly increases circulation to the affected area. The swelling is used to stimulate collagen regeneration and to heal the extracellular matrix (the attachment of cells to each other, allowing them to communicate). At the second stage of healing (the proliferative stage; a growth phase where collagen rapidly repairs, neovascularization occurs, and tissue cells reproduce and knit together), LLLT not only stimulates the collagen regeneration, but has also shown to improve the quality of the collagen that is produced at that time.
The photobiomodulation mode of action, is the wavelengths of light the low level laser produces, and will directly affect the amount of energy the mitochondria of the cell makes. More energy produced by the laser means the cell zooms around faster, like giving sugar to a toddler!
The Erchonia laser received an FDA Clearance for Nociceptive Musculoskeletal Pain (K) in June , making it a great part of recovery for both athletes and daily warriors, seeking to live healthier lives. Low back pain (K) was one of the other clearances for Erchonia, in . We know today that 8 out of 10 Americans will suffer from low back pain in their lifetime, making it crucial for cutting edge technology and continued research.
This is a systematic review protocol for clinical trials. The aim of this systematic review is to investigate the safety and effectiveness of LLLT compared with active conventional treatment, sham LLLT, or no treatment, or as an additional treatment compared with active treatment alone, in patients with DPN. This protocol was registered with the International Prospective Register of Systematic Reviews on April (registration number: CRD; http://www.crd.york.ac.uk/prospero/).
To be included in this analysis, studies will need to meet the following criteria regarding types of studies, participants, interventions, controls, and outcomes (Table 1).
Table 1 The inclusion criteriaFull size table
The randomized controlled trials (RCTs) that focus on LLLT in patients with DPN will be included. In contrast, reviews, case reports, animal experiments, meeting abstracts, and any publications without primary data or an explicit description of the methods will be excluded. Besides, we will only include the articles written in Chinese or English.
Adults (older than 18 years) with a clinically confirmed diagnosis of DPN will be included. The diagnostic criteria refer to the standards established by the Chinese Medical Association Diabetes Branch [22] or American Diabetes Association [23, 24]. We will exclude any RCTs that investigated patients with other types of peripheral neuropathy. Besides, patients with severe heart disease, liver and kidney dysfunction, mental illness, or malignant tumors will be not included.
Currently, lasers with an output power of less than 500 mW are referred to as low-level lasers in the field of medicine. Common medical LLLTs include (but are not limited to) He-Ne lasers, semiconductor lasers, and CO2 lasers. RCTs will be included if they compare LLLT with any of the following control interventions: sham LLLT, no (specific) treatment except conventional diabetes treatments, or active conventional medical treatment. RCTs will also be included if they evaluate LLLT as an addition to another active treatment.
A.
LLLT vs. sham LLLT
B.
LLLT vs. no treatment
C.
LLLT vs. active conventional medical treatment
D.
LLLT plus conventional medical treatment X vs. conventional medical treatment X alone
The major outcomes for this review include NCV and clinical scores that assess neurological function and related symptoms.
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NCV consists of motor NCV and sural sensory NCV. Clinical scores that assess neurological function and related symptoms include (but are not limited to) the Michigan Neuropathy Screening Instrument, Toronto Clinical Scoring System, Total Symptom Score, Neuropathy Deficit Score, and Neuropathy Symptom Score.
Outcomes will be recorded in two time periods: (1) short-term follow-up (less than or equal to 3 months and closest to 8 weeks after randomization) and (2) if available, long-term follow-up (more than 3 months and closest to 6 months after randomization).
Minor outcomes at both the short- and long-term follow-up will consist of quality of life such as the Short Form36 (SF-36), EuroQol five dimensions questionnaire (EQ-5D), and NeuroQol; pain assessment tools such as visual analog scale (VAS), neuropathic pain scale (NPS), Neuropathic Pain Questionnaire (NPQ), Short-form McGill Pain Questionnaire (SF-MPQ), and Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN); and adverse events associated with LLLT as a list of events.
A systematic literature search will be conducted in the following electronic bibliographic databases: MEDLINE (PubMed), Embase, Cochrane Central Register of Controlled Trials, Web of Science (Science and Social Science Citation Index), Chinese National Knowledge Infrastructure (CNKI), VIP China Science and Technology Journal Database (VIP), WanFang Database, and SinoMed, from their inception to December . Two sets of keywords were chosen to identify the pertinent papers. The first set assessed the target population. The second set specified the type of intervention. A wildcard symbol (*) was used for generalizing keywords typically characterized by varying suffixes. The search was performed by inserting logical conjunctions (AND/OR) between the sets. Search areas included the 'Mesh,' 'title,' and 'abstract' fields (Table 2). The articles need to be written in English or Chinese.
Table 2 Search strategy for the MEDLINE (PubMed) databaseFull size table
To overcome any deficiencies of the electronic databases, the following websites will also be searched for other clinical trial registries and gray literature about LLLT for DPN: Chinese Clinical Trial Registry (http://www.chictr.org.cn/), World Health Organization International Trials Registry Platform (www.who.int/trialsearch/Default.aspx), China Dissertations Database, GreyNet International (http://www.greynet.org), Grey Literature Report (http://www.Greylit.org/), Google Scholar (http://scholar.google.com/), Baidu Scholar (https://xueshu.baidu.com).
All data retrieved through the performed search will be imported into Endnote X7, and duplicate data from the different databases will be removed. Two reviewers will independently screen the title and abstract of each study and make a decision to include it or not, according to pre-specified criteria. Next, the full text of the initially included literature will be retrieved. Two reviewers will carefully read the full text and make the final selections. Any discrepancies between the two reviewers will be resolved through consensus and by third-party adjudication, as needed. The study selection procedure is shown in Fig. 1.
Fig. 1Flow chart of the search process
Full size image
The following data will be extracted from each included study: first author name, publication year, sample sizes, design, age, sex, BMI, diabetes duration, fasting blood glucose (FBG), postprandial blood glucose (2hPBG), glycosylated hemoglobin (HbA1c), DPN duration, intervention descriptions, comparators, treatment duration, follow-up periods, outcomes, and adverse events (Tables 3 and 4). Two reviewers will independently extract the data, and any differences will be solved by discussion. We will contact the authors of any studies that do not report the aforementioned data (via ) to obtain the original data. We will conduct sensitivity analyses if the missing data are still not obtained.
Table 3 General information of recruited studiesFull size table
Table 4 Characteristics of the intervention and outcomesFull size table
Two reviewers will independently assess the risk of bias of each study using the updated Cochrane Risk of Bias 2.0 tool [25]. This tool consists of six domains (randomization process, intended interventions, missing outcome data, measurement of the outcome, selection of the reported result, and overall bias). Each separate domain will be rated as having a low risk of bias, some concerns, or a high risk of bias. Disagreements between the two reviewers will be resolved through consensus and by third-party adjudication, as needed [26].
We will extract the main parameters of included articles according to the aim of this systematic review through Table 3, in which the article's characteristics, methods, description of population, intervention descriptions, comparators, treatment duration, follow-up periods, outcomes, and adverse events will be included. After summarization of data, it will be determined if a meta-analysis is possible. If possible, Review Manager software version 5.3, provided by the Cochrane Collaboration, will be used to perform data synthesis and analysis. All experimental and control groups such as A, B, C, and D described in intervention will be evaluated as a single category.
We will select different evaluation methods according to the different types of data. Pooled dichotomous data will be presented as odds ratios or relative ratios with 95% confidence intervals. Pooled continuous data will be expressed as mean differences or standardized mean differences with 95% confidence intervals, depending on whether the measurement scale is consistent or not. Heterogeneity will be assessed by the chi-squared test and I2 statistic. If there is no heterogeneity (P > 0.1, I2 < 50%), the data will be synthesized using a fixed effect model. In contrast, a random-effects model will be used if (P < 0.1, I2 > 50%). Furthermore, we will use subgroup or sensitivity analyses to explore the potential reasons for the differences in heterogeneity. We will conduct a general descriptive analysis if a meta-analysis cannot be performed.
Statistical heterogeneity will be assessed by I2 statistic. When the I2 is greater than 50% (i.e., there is substantial heterogeneity), the possible sources of clinical heterogeneity are judged by combining the differences in population characteristics (e.g., comorbidity, age, gender, BMI, blood sugar indicators, DPN duration), intervention (e.g., different laser parameters such as energy density, wavelength, different intervention forms), outcome evaluation methods, and control selection in the studies included in the comparison of clinical knowledge, and then verified by subgroup analysis and sensitivity analysis.
For the primary outcomes of NCV and clinical scores, the trials will be sub-grouped by dosage of LLLT such as energy density (greater than 3 J/cm2 or not), therapeutic schedules (whether or not sufficient treatment duration and sessions), BMI (' 24 kg/m2 or not), and blood sugar indicator of patients (FBG ' 7 mmol/L and 2hPBG ' 8 mmol/L, above this standard or no report)
In the sensitivity analysis, the following two types of studies will be excluded, one by one: (1) studies missing data, and (2) studies with a high risk-of-bias rating. The impacts of research quality, sample sizes, missing data, and statistical methods on the results of the meta-analysis will be evaluated by merging the data.
If the number of studies is more than 10, a funnel plot will be constructed to examine publication bias.
The quality of evidence for the entire study will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach [27]. The limitations of study design, inconsistency, indirect evidence, inaccuracy, and publication bias will be evaluated. The GRADE system classifies the evidence into four levels: high, moderate, low, or very low.
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