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Objective: The main aim of this systematic review is to evaluate the effectiveness of therapeutic exercise for managing pain and disability in patients with cervicogenic headache (CEH). Methods: A protocol for this systematic review was published in PROSPERO (CRD42019122703). PRISMA and AMSTAR2 standards were followed. Based on an extensive systematic search in five databases (EMBASE, MEDLINE, CINHAL, PsychInfo and SportDISCUS) and the CENTRAL trial register, two reviewers carefully and independently assessed, selected results, collected data, rated the risk of bias (RoB) of included studies with the Cochrane risk of bias tool, synthesized the available evidence, and rated it using GRADE methodology.
Results: A total of 12 manuscripts, reporting on 11 studies were included. Most studies showed a high risk of bias (63,63%). Additionally, a great deal of heterogeneity was observed regarding interventions, comparisons, and outcomes and thus, results could not be synthesized in meta-analyses. The quality of the evidence was found to be from low to very low. Significant differences with large effect sizes were found when comparing multimodal exercise vs. control groups on headache outcomes (SMD = 0.73; 95%CI [0.31, 1.14] for headache intensity and SMD = 0.98; 95%CI [0.56, 1.41], for headache frequency).
Conclusions: Findings indicate that therapeutic exercise may be effective to achieve clinically relevant reductions in headache intensity and frequency as well as disability for patients suffering from cervicogenic headache. However, more high-quality research is needed to gain confidence in this finding and possibly determine optimal types and dosage of therapeutic exercise.
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.
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.
A thorough knowledge of biases in intervention studies and how they influence study results is essential for the practice of evidence-based medicine. The objective of this review was to provide a basic knowledge and understanding of the concept of biases and associated influence of these biases on treatment effects, focusing on the area of rehabilitation research. This article provides a description of selection biases, confounding, and attrition biases. In addition, useful recommendations are provided to identify, avoid, or control these biases when designing and conducting rehabilitation trials. The literature selected for this review was obtained mainly by compiling the information from several reviews looking at biases in rehabilitation. In addition, separate searches by biases and looking at reference lists of selected studies as well as using Scopus forward citation for relevant references were used. If not addressed appropriately, biases related to intervention research are a threat to internal validity and consequently to external validity. By addressing these biases, ensuring appropriate randomization, allocation concealment, appropriate retention techniques to avoid dropouts, appropriate study design and statistical analysis, among others, will generate more accurate treatment effects. Based on their impact on clinical results, a proper understanding of these concepts is central for researchers, rehabilitation clinicians, and other stakeholders working on this field.
Methods: The searches were conducted on five electronic databases. RCTs or CTs with patients over 18 years old of both sexes with OFP diagnoses were targeted. The intervention of interest was AE (i.e., walking, cycling, and running), compared to any other conservative and non-conservative therapy. The primary outcome was pain intensity. Risk of bias (RoB) was done with the Cochrane RoB tool (RoB 2). The overall certainty of the evidence was evaluated with GRADE.
Results: Out of 21,585 initial records found in the initial database search, only one study (reported on three manuscripts) was included. The diagnosis of interest was headache plus temporomandibular disorders (TMD). Three treatment groups (strengthening (Str) exercise + manual therapy (MT) (G1); AE + MT + Str exercises (G2); AE (G3)) were compared. The main outcome was pain; the secondary outcomes included disability, strength, anxiety, and quality of life. The combined treatment (AE+MT+Str exercises) had the strongest effect to decrease pain and headache intensity in patients with OFP (SMD: 9.99 [95%CI: 7.19, 12.80].
Conclusions: a multimodal treatment strategy achieved the greatest positive effects on pain and other outcomes in the short/medium term. AE seems to be an important component of this strategy. However, the scientific evidence supporting AE’s isolated effect is limited, indicating a research gap in this scientific field.
Objective
Summarize the evidence from randomized controlled trials and controlled trials that examined the effectiveness of electrotherapy in the treatment of patients with orofacial pain.
Data Source
Medline, Embase, CINAHL PLUS with Full text, Cochrane Library Trials, Web of Science, and Scopus.
Review Methods
A data search (last update, July 1, 2022) and a manual search were performed (October 5, 2022). Trials involving adults with orofacial pain receiving electrotherapy compared with any other type of treatment were included. The main outcome was pain intensity; secondary outcomes were mouth opening and tenderness. The reporting was based on the new PRISMA Guidelines.
Results
From the electronics databases and manual search 43 studies were included. Although this study was open to including any type of orofacial pain, only studies that investigated temporomandibular disorders were found. The overall quality of the evidence for pain intensity was very low. Although the results should be carefully used, transcutaneous electric nerve stimulation therapy showed to be clinically superior to placebo for reducing pain after treatment (2.63 [−0.48; 5.74]) and at follow-up (0.96 [−0.02; 1.95]) and reduce tenderness after treatment (1.99 [−0.33; 4.32]) and at follow-up (2.43 [−0.24; 5.10]) in subjects with mixed temporomandibular disorders.
Conclusion
The results of this systematic review support the use of transcutaneous electric nerve stimulation therapy for patients with mixed temporomandibular disorders to improve pain intensity, and tenderness demonstrating that transcutaneous electric nerve stimulation is superior to placebo. There is inconsistent evidence supporting the superiority of transcutaneous electric nerve stimulation against other therapies.
Bias is a systematic error that can cause distorted results leading to incorrect conclusions. Intervention bias (i.e., contamination bias, cointervention bias, compliance bias, and performance bias) and detection bias are the most common biases in rehabilitation research. A better understanding of these biases is essential at all stages of research to enhance the quality of evidence in rehabilitation trials. Therefore, this narrative review aims to provide insights to the readers, clinicians, and researchers about contamination, cointervention, compliance, performance, and detection biases and ways of recognizing and mitigating them. The literature selected for this review was obtained mainly by compiling the information from several reviews looking at biases in rehabilitation. In addition, separate searches by biases and looking at reference lists of selected studies as well as using Scopus forward citation for relevant references were used.
This review provides several strategies to guard against the impact of bias on study results. Clinicians, researchers, and other stakeholders are encouraged to apply these recommendations when designing and conducting rehabilitation trials.
Understanding Clinical Significance in Rehabilitation : A Primer for Researchers and Clinicians
(2022)
The objective of this review was to summarize the concept of clinical significance and associated methods focusing on the area of rehabilitation to provide a resource to rehabilitation researchers and clinicians. Studies were searched on electronic databases from inception until July 28, 2020, with no date or language limits. Manual searches as well as Scopus forward citation for relevant references were performed. Narrative synthesis of study results was performed. Definitions of the concepts related to clinical significance, ways of calculating, and interpreting each method were provided using rehabilitation examples. An explanation of methods to evaluate clinical significance (distribution, anchor, and opinion-based methods) and their advantages and disadvantages were also provided. Considering the limitations of statistical significance in assuring meaningfulness of results, clinical interpretation of research outcomes and the report of clinical significance in intervention trials should be a priority in rehabilitation research. When possible, the use of multiple methods (distribution, anchor, and opinion based) is recommended. Thus, clinical researchers are encouraged to present results in a manner that allow the rehabilitation professionals to easily interpret and implement those results in their clinical practice.