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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 The evidence regarding the effectiveness of aerobic exercise for neck pain seems limited and outdated.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.
Hypothesis/Aims of study
Many results related to the effectiveness of surgical and non-surgical proce- dures for treating urinary incontinence (UI) are reported in the literature. Following the principles of evidence based-practice, besides the interpreta- tion of study results based on statistical significance, authors should consid- er evaluating the clinical relevance of treatment effects in this field.
The minimal important difference (MID) of clinical outcomes could be used to assess the clinical relevance of interventions. MID is defined as “the small- est difference in score in the domain of interest that patients perceive as important, either beneficial or harmful, and which would lead the clinician to consider a change in the patient’s management’’[1]. One common way to obtain MID for outcomes of interest is by using anchor-based methods. These methods apply one anchor that analyzes the change in the patient's health status according to the patient’s perception.
However, MIDs should be provided according to appropriate calculations and methods and based on the definition of a MID. However, there are a lot of misconceptions and misunderstandings related to the MID. These mis- understandings have led to incorrect reports of these values. Moreover, it is still not known which criteria the authors considered during the analysis of the MID in the Women’s Health area. Therefore, with this preliminary re- port, we aimed to identify and report all anchor-based methods to estimate MIDs for outcomes measures related to UI available in the literature; and analyze which concepts and levels of improvement in the health status of the patient have been considered by the authors to calculate the MID.
Study design, materials and methods
This systematic review was conducted according to PRISMA guide- lines. The study protocol was registered in the PROSPERO database (CRD42022299686). A systematic search was performed using Ovid Med- line, Embase, Web of Science, and Scopus from May to June 2021. Any study generating MIDs for UI that included women with more than 18 years, stress urinary incontinence (SUI), urgency urinary incontinence (UUI) and/ or miXed urinary incontinence (MUI) was included. The primary outcome was the MID for outcomes related to UI. No limits were applied on the data- bases for the date, language or publication range.
Studies were classified into three categories according to the level of im- provement in health status assessed by the anchor and considered by the authors during the MID calculation: 1) slight improvement: if authors in- cluded participants that evaluated their health status as “a little better” in their analysis; 2) moderate improvement: if authors considered women that reported a “better” or a “much better” status of the condition; or 3) strong imporvement: if all patients that improved (“very much better” or if authors grouped all the patients that improved in one single category) were consid- ered in one group against other group that did not report any improvement. After classifying the papers, we counted and reported how many studies were considering only the minimal level of improvement to reported the MID, according to previous definition and recommendation.
The initial electronic search resulted in a total of 1,662. After removing du- plicates (n=719), 943 were screened, and at the end of the selection stages, nine papers that reported anchor-analysis were included in this preliminary report. Seven studies included women with SUI (total sample size= 2,436), while one study included only women with UUI (n=307), and the other one evaluated women with SUI and MUI (n=288). SiX studies analyzed data and provided the MID after a non-surgical treatment of UI, while three analyzed the results after surgery to correct UI. Eleven different questionnaires to measure the patient-related outcomes related to UI with their MIDs were identified. All the tools were related to measuring the impact, distress, or quality of life of women with UI.
Different anchors were used to analyze MID, including scales that evaluated the improvement and satisfaction of the patient, and the visual analogue scale, measures of urinary leakage and questionnaires that measure the se- verity and impact of UI. The MID of siX tools was determined according to the smallest difference detected by the patients, using the Patient Global Im- pression of Improvement questionnaire and the self-reported satisfaction to assess the change of the condition. Most of the MIDs (n=28, 80%) were mis- calculated considering a moderate or a strong improvement of the patients, and not a minimal improvement as suggested by the literature (Table 1).
Interpretation of results
Although previous systematic reviews have reported the psychometric prop- erties of different questionnaires to measure UI outcomes, this is the first study to analyze methods of obtaining MIDs for UI outcomes from the pa- tients perspective (anchor based methods). All the tools with their respec- tives MIDs were related to the impact, distress, and/or quality of life of women with UI. The use of these outcomes measures is in line with the as- sociated impairments of social, psychological, financial, and sexual aspects of a women’s life produced by UI.
Most of the authors in this field did not consider the smallest difference identified by the participants to calculate the MID, which does not follow the original definition of MID proposed by Jaeschke et al.,1 This could gen- erate underestimation or over-estimation of MID, which may directly im- pact the interpretation of the findings from the clinical trials[2] and biased interpretation of the results of the clinical significance from the interven- tions used to manage female UI. Therefore, the interpretation of the clinical significance related to UI outcomes should be done with caution.
Concluding message
Few studies that aimed to calculate the MID using anchor-based methods for outcomes related to female UI were found in the literature. Eleven different questionnaires to measure the outcomes related to UI with their MIDs were identified. However, most studies had not considered the smallest change of improvement (as perceived by the patients) in their analysis, which does not follow the definition of the MID. This could impact decision making. Future research should provide clear guidelines on how to calculate, report, and interpret MIDs in this field.