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Background:
The evaluation of somatosensory dysfunction is important for diagnostics and may also have implications for prognosis and management. The current standard to evaluate somatosensory dysfunction is quantitative sensory testing (QST), which is expensive and time consuming. This study describes a low-cost and time-efficient clinical sensory test battery (CST), and evaluates its concurrent validity compared to QST.
Method: Three patient cohorts with carpal tunnel syndrome (CTS, n=86), non-specific neck and arm pain (NSNAP, n=40) and lumbar radicular pain/radiculopathy (LR n=26) were included. The CST consisted of 13 tests, each corresponding to a QST parameter and evaluating a broad spectrum of sensory functions using mechanical and thermal detection and pain thresholds and testing both loss and gain of function. Agreement rate, significance and strength of correlation between CST and QST were calculated.
Results: Several CST parameters (cold and warm detection, cold pain, mechanical detection, mechanical pain for loss of function, pressure pain) were significantly correlated with QST, with a majority demonstrating >60% agreement rates and weak to relatively strong correlations. However, agreement varied among cohorts. Gain of function parameters showed stronger correlation in the CTS and NSNAP cohort, whereas loss of function parameters performed better in the LR cohort. Other CST parameters (vibration detection, heat pain, mechanical pain for gain of function, windup ratio) did not significantly correlate with QST.
Conclusion: Some, but not all tests in the CST battery can detect somatosensory dysfunction as determined with QST. The CST battery may perform better when the somatosensory phenotype is more pronounced.
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.
Relationship of QST measures between low back and leg sites in people with radicular leg pain
(2019)
Background and Aims
Clinicians and researchers often rely on altered neurological integrity tests in the leg to identify radicular pain, however neurological integrity is often not tested in the low back region even in the presence of pain in this region. There have been suggestions that the low back pain itself could be neuropathic in nature in some patients (Baron et al., 2016). This study aims to explore the relationship between quantitative sensory testing (QST) measures in the leg and low back in participants with radicular leg pain to consider if sensory testing should be performed in both areas in clinical practice.
Methods
13 participants (mean age 48.2 SD 13.8, gender (female) 8) with radicular leg pain were recruited from National Health Service spinal clinics in the UK. After assessment with the clinician, a full QST profile was taken from each participant’s affected leg and low back. Z scores were calculated using data from age matched healthy controls. Correlations using Pearson’s if the data was normally distributed or Kendall’s Tau-b if not, were undertaken between QST scores of the low back and leg. Paired t tests or Mann Whitney tests were performed to assess differences in QST scores between the leg and low back regions.
Results
There were no significant correlations (P>0.05) in any of the QST measures between the leg and the low back regions. However, only vibration detection threshold measures showed statistically significant differences between the leg and low back (p<0.001), with the low back region showing greater loss of function (mean -2.84) than the leg (mean -0.61).
Conclusions
Significantly lower vibration thresholds were found in the back compared to the leg. This may suggest some alteration in posterior primary ramus large diameter afferent nerve function, and indicate that the low back pain itself may indeed have a neuropathic component. Our findings suggest that sensory testing of the lumbar spine may be advisable in this group of individuals. The small sample size means that these results must be taken with some caution, however these results warrant further investigation in people with radicular leg pain.
Despite normal neurological bedside and electrodiagnostic, some patients with non-specific neck arm pain (NSNAP) have heightened nerve mechanosensitivity upon neurodynamic testing [1, 2]. It remains however unclear whether this is associated with a minor nerve injury. The aim of this study was to evaluate potential differences in somatosensory function among patients with unilateral NSNAP with and without positive neurodynamic tests and healthy controls.
Quantitative sensory testing was performed in 40 patients with unilateral NSNAP; 23 with positive upper limb neurodynamic tests (ULNTPOS) and 17 with negative neurodynamic tests (ULNTNEG). The protocol comprised thermal and mechanical detection and pain thresholds as well as mechanical pain sensitivity, wind-up ratio and dynamic mechanical allodynia. All parameters were measured in the maximal pain area on the affected side as well as over the corresponding area on the unaffected side. Symptom severity, functional deficits, psychological parameters, quality of life and sleep disturbance were also recorded.
Fifty-seven percent of patients with NSNAP had positive neurodynamic tests despite normal bedside neurological integrity tests and nerve conduction parameters. Clinical profiles did not differ between patient groups. Somatosensory profiling revealed a more pronounced loss of function phenotype in ULNTPOS patients compared to healthy controls. Hyperalgesia (cold, heat and pressure pain) was present bilaterally in both NSNAP group. The ULNTNEG subgroup represented an intermediate phenotype between ULNTPOS patients and healthy controls in both thermal and pressure pain thresholds as well as mechanical detection thresholds.
In conclusion, heightened nerve mechanosensitivity was present in over half of patients with NSNAP. Our data suggest that NSNAP presents as a spectrum with some patients showing signs suggestive of a minor nerve dysfunction.
[1] Elvey RL. Physical evaluation of the peripheral nervous system in disorders of pain and dysfunction. J Hand Ther 1997;10:122-129.
[2] van der Heide B, Bourgoin C, Eils G, Garnevall B, Blackmore M. Test-retest reliability and face validity of a modified neural tissue provocation test in patients with cervicobrachial pain syndrome. J Man Manip Ther 2006;14:30-36.