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A systematic review of the effectiveness of mass media campaigns for the management of low back pain
(2021)
Purpose
To synthesize evidence on the effectiveness of mass media campaigns for the management of LBP on beliefs of the general public and health care providers, LBP-related disability, health utilization, and LBP clinical outcomes.
Objective
Some recent studies suggest that double blinding should not be considered a validity criterion in randomized controlled trials (RCTs) on real-life circumstances. This study aims to assess whether blinding vs. nonblinding have been analyzed conceptually in the rehabilitation literature. Propositions on the role of blinding in RCTs on rehabilitation are presented based on the conceptual analysis.
INTRODUCTION: Attrition, missing data, compliance, and related biases are three interrelated concepts. Previous research has found that these biases can affect the treatment estimates of randomized trials (RCTs). The extent to which the effects of attrition, missing data, compliance and related biases influence effect size estimates in rehabilitation as well as the effect of analytic strategies to mitigate these biases is unknown.
EVIDENCE ACQUISITION: To compile and synthetize the empirical evidence regarding the effects of attrition and compliance related biases on treatment effect estimates in rehabilitation RCTs. Electronic searches were conducted. Studies were included if they investigated the effects of attrition, missing data, compliance and related biases on treatment estimates. The seven studies meeting inclusion criteria were coded for type of biases and summarized using a narrative and/or quantitative approach when appropriate.
EVIDENCE SYNTHESIS: Findings demonstrated that trials reporting higher levels of attrition (differences in ES: 0.18 [95%CI: 0.15, 0.22 ]), exclusion of participants from analyses (differences in ES: 0.13 [95% CI: -0.03, 0.29]), lack of good control of incomplete outcome data (differences in ES: 0.14 [95%CI: -0.02, 0.30]) and analysis by “as treated”(differences in ES:-0.39 [95%CI: -0.99, 0.2]) or “per protocol” (differences in ES:-0.46 [95%CI: -0.92, 0]) analyses were more likely to have higher effects than those that did not.
CONCLUSIONS: These findings suggest that attrition, missing data, compliance, and related biases have an influence in treatment effect estimates in rehabilitation trials. Therefore, these results should be taken into consideration when designing, conducting and reporting trials in the rehabilitation field.
Background:
Neck pain is one of the most common musculoskeletal pains and among the fourth leading causes of years of life lost due to disability, following back pain, depression, and arthralgia. (1)
In the course of their lives, about 70% of all people will experience a clinically relevant episode of neck pain, (2) so finding a good therapy to treat it is of high interest. Aerobic exercise is associated with pain reduction in patients with different types of MSK pain. Recent studies have shown a positive impact of aerobic exercises on brain function, memory processing, cognition, and motor function. (3, 4)
Therefore, the influence of aerobic exercise on pain modulation seems to be of particular interest for individuals with chronic MSK pain, since brain imaging studies have shown that these patients have structural and functional changes, as well as abnormal brain features in various areas of the brain. The evidence regarding the effectiveness of aerobic exercise for neck pain seems limited and outdated.
Thus, a systematic review evaluating the effects of aerobic exercise in patients with neck pain is needed. Therefore, this review aims to investigate the effectiveness of aerobic exercise interventions when compared to other conservative and non-conservative interventions (e.g., localized exercises, medication, acupuncture, physical agents, manual therapy) to decrease pain intensity in people with neck pain.
Materials and methods:
Electronic literature searches were conducted in a total of six databases such as Medline, Embase, CINAHL, Cochrane Library, Web of Science, and Scopus. The review considered randomised controlled trials (RCTs) including patients over 18 years having musculoskeletal pain in the neck area. The Neck Pain Task Force's classification of pain severity describes four levels of neck pain, with the first three levels considered in this review. (5)These must be clinically diagnosed by a health care provider according to signs and symptoms or based on standardized criteria specific for each disease. Studies involving subjects with any pre-existing conditions, previous surgery, or pain not clearly related to the musculoskeletal system were excluded. No limits were applied in terms of sex, ethnicity, and living country. Data were extracted using a standardized data extraction form.
Methodological quality was determined using the Cochrane Collaboration Risk of Bias Tool (CCRBT) and the strength of the evidence with Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Data were extracted and evaluated by two independent reviewers.
Results:
A total of 21585 records were identified and screened independently for eligibility by two reviewers. A total of six unique studies, reported on ten manuscripts met the specified inclusion criteria. Different types of aerobic exercise were used in the studies. Studies included isolated and combined aerobic exercise using interventions such as cycling on an ergometer or walking outdoors at a moderate intensity. Comparison groups were for example strength training or education. The most common outcome was pain assessed with the Visual Analogue Scale (VAS) or the Nordic questionnaire.
The included studies had a high risk of bias and the overall quality of the evidence for this systematic review was considered low. There was high heterogeneity in the included studies regarding interventions applied and study results.
When looking at the effect of aerobic exercise versus control group or other intervention groups measured with VAS, it can be observed, that there was a great heterogeneity between studies results (different magnitudes and directions). Although none of the comparisons showed a statistically significant difference between aerobic exercise and control (MD 6.24 mm, 95% CI [-11.21; 23.96]) or active intervention groups (MD -9.52 mm, 95% CI [-18.48; -0.56]) on pain intensity; it seems that aerobic exercise is slightly better than a control group, and equally effective as other active treatments such as strength exercise or education.
In addition, when combined with other therapeutic modalities, aerobic exercise, could potentially help to reduce pain intensity (MD 7.71 mm, 95% CI [1.07; 14.35]). Especially in the long term, the combination of strength and aerobic exercise showed promising results. Statistically significant differences in favour of aerobic exercise for pre vs. three months follow up (MD 11.20 mm, 95% CI [2.85;19.55]) and pre vs. six moths follow up (MD 15.10 mm, 95% CI [6.99; 23.21]) were found.
Conclusions:
Although there is currently limited evidence on the effectiveness of aerobic exercise in individuals with chronic neck pain, aerobic exercise was found to not only reduce pain intensity, but also to improve disability as well as physical and emotional functioning. However, as the evidence is limited, low quality, and heterogeneous, further research is needed in this area to obtain more accurate results.
Background: Virtual reality (VR) has been defined as a computer-generated display that allows the user to have a sense of being present and interacting in an environment other than the one they are actually in.[1] VR has been used to relieve and improve function in several musculoskeletal disorders (MSKD) [2-4], including neck pain (NP). However, there is still a lack of evidence on the effectiveness of VR for the management of NP. Several systematic reviews (SR) have been published regarding the effectiveness of VR on MSK disorders,[2-6] but none of these SRs looked specifically at the effectiveness of VR on NP-associated disorders. Based on these statements, this SR has some specific aims: (1) summarizing the evidence from randomized controlled trials (RCTs) and controlled trials (CTs) that examined the effectiveness of active VR used in the treatment of patients with NP, and (2) to determine the clinical effectiveness and the magnitude of the effect of active VR in the management of NP.
Methods: This is a SR with meta-analysis that performed a literature search of five electronic databases (Ovid Medline, Embase, Cinahl, Scopus, and Cochrane Library) in September 2023 in partnership with a health science librarian without restriction in terms of publication year and language. It included RCTs and CT with adults (>18 years old) with NP, and the evaluation of the effectiveness of active VR or augmented VR. VR could be implemented by using off-the-shelf or custom-made devices, in combination with a display allowing a multisensory experience and active interaction with the virtual world. [7,8] First (abstract and title) and second (full text) screening, data extraction, and risk of bias (Cochrane RoB-2 tool) assessments were performed by two independent reviewers. The results were presented qualitatively and quantitatively. When possible, the data from the included studies were pooled in a meta-analysis. The certainty of evidence was assessed using the GRADE approach.
Results: In the first screening, 8.208 studies were selected, and nine studies were included. All studies revealed a significant pain reduction in all interventions (either VR or control groups) after the end of the treatment. The VR group performed better results on pain intensity after treatment compared to conventional exercises (SMD [95%CI]: 0.43 [0.04, 0.83]) but it was not statistically different from kinematic exercise (SMD [95%CI]: 0.43 [0.50 [-0.06, 1.06]), and control group (waiting list) (SMD [95%CI]: 0.27 [-0.13, 0.66]). Although VR had positive results in all outcomes analyzed within group, no statistically or clinically significant differences were found between the VR and other interventions, in other outcomes (fear of movement, neck ROM, balance, and quality of life). Most of the studies (5 studies) presented some concerns and four studies presented a high RoB based on the RoB-2 tool. The overall quality of the evidence was considered as “very low” by the GRADE approach.
Conclusion: Although the evidence is still limited for the VR treatment in patients with NP, the results found in this SR bring an important indication that the implementation of VR in existing rehabilitation for patients with neck pain appears to be a potentially safe and promising treatment approach to relieve pain and could be an alternative more effective to conventional exercise treatments that normally are employed in clinical practice.
This review presents a comprehensive summary and critical evaluation of Intention to Treat (ITT) analysis, with a particular focus on its application to randomized controlled trials (RCTs) within the field of rehabilitation. Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a methodological review that encompassed electronic and manual search strategies to identify relevant studies. Our selection process involved two independent reviewers who initially screened titles and abstracts and subsequently performed full-text screening based on established eligibility criteria. Additionally, we included studies from manual searches that were already cataloged within the first author’s personal database. The findings are synthesized through a narrative approach, covering fundamental aspects of ITT, including its definition, common misconceptions, advantages, disadvantages, and key recommendations. Notably, the health literature offers a variety of definitions for ITT, which can lead to misinterpretations and inappropriate application when analyzing RCT results, potentially resulting in misleading findings with significant implications for healthcare decision-making. Authors should clearly report the specific ITT definition used in their analysis, provide details on participant dropouts, and explain upon their approach to managing missing data. Adherence to reporting guidelines, such as the Consolidated Standards of Reporting Trials (CONSORT) for RCTs, is essential to standardize ITT information, ensuring the delivery of accurate and informative results for healthcare decision-making.
Purpose
To determine the effectiveness of different types of acupuncture in reducing pain, improving maximum mouth opening and jaw functions in adults with orofacial pain.
Methods
Six databases were searched until 15 June 2023. The Cochrane risk of bias tool and GRADE were employed to evaluate bias and overall evidence certainty.
Results
Among 52 studies, 86.5% (n = 45) exhibited high risk of bias. Common acupoints, including Hegu LI 4, Jiache ST 6, and Xiaguan ST 7, were used primarily for patients with temporomandibular disorder [TMDs]. Meta-analyses indicated that acupuncture significantly reduced pain intensity in individuals with myogenous TMD (MD = 26.02 mm, I2=89%, p = 0.05), reduced tenderness in the medial pterygoid muscle (standardised mean differences [SMD] = 1.72, I2 = 0%, p < 0.00001) and jaw dysfunction (SMD = 1.62, I2 = 88%, p = 0.010) in mixed TMD when compared to sham/no treatment. However, the overall certainty of the evidence was very low for all outcomes as evaluated by GRADE.
Conclusion
The overall results in this review should be interpreted with caution as there was a high risk of bias across the majority of randomized controlled trial (RCTs), and the overall certainty of the evidence was very low. Therefore, future studies with high-quality RCTs are warranted evaluating the use of acupuncture in patients with orofacial pain.
IMPLICATIONS FOR REHABILITATION
Acupuncture could potentially reduce subjective pain intensity and sensitivity of masticatory muscles, improve mouth opening, and reduce dysfunction in orofacial pain, specifically in patients with temporomandibular disorder (TMD).
Acupuncture points such as LI4, ST6, ST7, GB20, SI19, ST36 were the most commonly used acupuncture points to treat patients with orofacial pain, especially TMDs.
Clinicians can use the information in this review with caution to develop an effective and appropriate treatment regimen for the acupuncture treatment of patients with TMDs.
INTRODUCTION: Attrition, missing data, compliance, and related biases can influence the magnitude of treatment effects in randomized controlled trials (RCTs). It is unclear which items should be considered when reporting and evaluating the influence of these biases in trial reports in the rehabilitation field. The aim was to describe which individual items considering attrition, missing data, compliance, and related biases are included in quality tools used in rehabilitation research. In addition, we aimed to determine whether the existing reporting guidelines, such as the CONSORT and its extensions include all relevant items related to these biases when reporting RCTs in the area of rehabilitation.
EVIDENCE ACQUISITION: Comprehensive literature searches and a systematic approach to identify tools and items looking at attrition, missing data, compliance and related biases in rehabilitation were performed. We extracted individual items linked to these biases from all quality tools. We calculated the frequency of quality items used across tools and compared them to those found in the CONSORT statement and its extensions. A list of items to be potentially added to the CONSORT statement was generated.
EVIDENCE SYNTHESIS: Three new tools to assess the conduct and reporting of trials in the rehabilitation field were found. From these tools, 28 items were used to evaluate the reporting as well as the conduct of trials considering attrition, missing data, compliance, and related biases in the rehabilitation field. However, our team found that some of these items lack specificity in the information required and therefore more research is needed to determine a core set of items used for reporting as well as assessing the risk of bias (RoB) of RCT in the rehabilitation field.
CONCLUSIONS: Although many items have been described by existing tools and the CONSORT statement (and its extensions) that deal with attrition, missing data, compliance, and related biases, several gaps in reporting were identified. It is crucial that future research investigate a core set of items to be used in the field of rehabilitation to facilitate the reporting as well as the conduct of RCTs.