Effects of Inpatient Rehabilitation in Leg Lymphedema: A Naturalistic Prospective Cohort Study With Intra-individual Control of Effects.

OBJECTIVE: To quantify therapy-attributable effects of a comprehensive inpatient rehabilitation program for lower limb lymphedema (LLL) and to compare the levels of health-related quality of life (HRQL) to population-based norms. DESIGN: Naturalistic prospective cohort study with intra-individual control of effects. SETTING: Rehabilitation hospital. PARTICIPANTS: Patients with LLL (N=67; 46 women). INTERVENTIONS: Comprehensive, multidisciplinary inpatient rehabilitation with 45-60 hours of therapy. MAIN OUTCOME MEASURES: Short Form 36 (SF-36) for HRQL, lymphedema-specific Freiburg Quality of Life Assessment for lymphatic disorders, Short Version (FLQA-lk), knee-specific Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), and Symptom Checklist-90Standard (SCL-90S). Observed pre/post rehabilitation effects were individually corrected by subtracting the home waiting-time effects and expressed as standardized effect sizes (ESs) and standardized response means (SRMs). Score differences to norms were quantified by standardized mean differences (SMDs). RESULTS: Participants were on average aged 60.5 years, not yet obese, and had 3 comorbidities (n=67). The greatest improvement was in HRQL on the FLQA-lk with ES=0.767/SRM=0.718, followed by improvements in pain and function with ES/SRM=0.430-0.495 on the SF-36, FLQA-lk, and KOS-ADL (all P<.001). Vitality, mental health, emotional well-being, and interpersonal sensitivity improved most by ES/SRM=0.341-0.456 on all 4 measures (all P≤.003). Post rehabilitation scores were significantly higher than population norms on SF-36 bodily pain (SMD=1.140), vitality (SMD=0.886), mental health (SMD=0.815), and general health (SMD=0.444) (all P<.001), and comparable on the other scales. CONCLUSIONS: Those affected by LLL stages II and III benefited substantially from the intervention, attaining equal or higher levels of HRQL than expected compared with the general population norms. Multidisciplinary, inpatient rehabilitation should be recommended for LLL management.

Mental and psychosocial health and health related quality of life before and after cardiac rehabilitation: a prospective cohort study with comparison to specific population norms.

BACKGROUND: Data on mental health improvement after cardiac rehabilitation (CR) are contradictory. The aim was to examine the mental and psycho-social health of patients admitted to our rehabilitation center following hospital treatment for acute coronary syndrome, before and after multidisciplinary CR. METHODS: Outcome was measured at admission and discharge by the 36-Item Short Form Survey (SF-36), the Symptom Checklist-90 Revised (SCL-90R), the Coping Strategy Questionnaire (CSQ) and the 6-min-walking distance test. The patients' health status was compared with norms of sex-, age- and comorbidity-matched data from the German general population. Score differences from norms were measured by standardized mean differences (SMDs); health changes were quantified by standardized effect sizes (ESs). Their importance for comprehensive assessment was quantified by explorative factor analysis. RESULTS: Of n = 70 patients followed-up (male: 79%; mean age: 66.6 years), 79% had ≥ 3 comorbidities. At baseline, SF-36 Physical functioning (SMD = - 0.75), Role physical (- 0.90), Social functioning (SMD = - 0.44), and Role emotional (SMD = - 0.45) were significantly worse than the norm. After CR, almost all scores significantly improved by ES = 0.23 (SCL-90R Interpersonal sensitivity) to 1.04 (SF-36 Physical functioning). The strongest factor (up to 41.1% explained variance) for health state and change was the mental health domain, followed by function & pain (up to 26.3%). CONCLUSIONS: Normative deficits in physical and psycho-social health were reported at baseline. After CR, at follow-up, all scores, except phobia, showed significant improvement. The comprehensive measurement of bio-psycho-social health should not be limited to depression and anxiety but include, especially, the somatization and social participation dimensions.

Comprehensiveness and validity of a multidimensional assessment in patients with chronic low back pain: a prospective cohort study.

BACKGROUND: Chronic low back pain is a multidimensional syndrome affecting physical activity and function, health-related quality of life and employment status. The aim of the study was to quantify the cross-sectional and longitudinal validity of single measurement scales in specific construct domains and to examine how they combine to build a comprehensive outcome, covering the complex construct of chronic low back pain before and after a standardized interdisciplinary pain program. METHODS: This prospective cohort study assessed 177 patients using the Short Form 36 (SF-36), the Multidimensional Pain Inventory (MPI), the Symptom Checklist-90-Revised (SCL-90-R), the Oswestry Disability Index (ODI), and 2 functional performance tests, the Back Performance Scale (BPS) and the 6-Minute Walking Distance (6MWD). The comprehensiveness and overlap of the constructs used were quantified cross-sectionally and longitudinally by bivariate correlations, exploratory factor analysis, and effect sizes. RESULTS: The mean age of the participants was 48.0 years (+/- 12.7); 59.3% were female. Correlations of baseline scores ranged from r = - 0.01 (BPS with MPI Life control) to r = 0.76 (SF-36 Mental health with MPI Negative mood). SF-36 Physical functioning correlated highest with the functional performance tests (r = 0.58 BPS, 0.67 6MWD) and ODI (0.56). Correlations of change scores (difference of follow-up - baseline score) were consistent but weaker. Factor analysis revealed 2 factors: "psychosocial" and "pain & function" (totally explained variance 44.0-60.9%). Psychosocial factors loaded strongest (up to 0.89 SCL-90-R) on the first factor, covering 2/3 of the explained variance. Pain and function (ing) loaded more strongly on the second factor (up to 0.81 SF-36 Physical functioning at follow-up). All scales showed improvements, with effect sizes ranging from 0.16-0.67. CONCLUSIONS: Our results confirm previous findings that the chronic low back pain syndrome is highly multifactorial and comprises many more dimensions of health and quality of life than merely back-related functioning. A comprehensive outcome measurement should include the predominant psychosocial domain and a broad spectrum of measurement constructs in order to assess the full complexity of the chronic low back syndrome. Convergence and divergence of the scales capture the overlapping contents and nuances within the constructs.

The Anthelmintic Quassinoids Ailanthone and Bruceine a Induce Infertility in the Model Organism Caenorhabditis elegans by an Apoptosis-like Mechanism Induced in Gonadal and Spermathecal Tissues.

In continuation of the search for new anthelmintic natural products, the study at hand investigated the nematicidal effects of the two naturally occurring quassinoids ailanthone and bruceine A against the reproductive system of the model nematode Caenorhabditis elegans to pinpoint their anthelmintic mode of action by the application of various microscopic techniques. Differential Interference Contrast (DIC) and the epifluorescence microscopy experiments used in the presented study indicated the genotoxic effects of the tested quassinoids (c ailanthone = 50 µM, c bruceine A = 100 µM) against the nuclei of the investigated gonadal and spermathecal tissues, leaving other morphological key features such as enterocytes or body wall muscle cells unimpaired. In order to gain nanoscopic insight into the morphology of the gonads as well as the considerably smaller spermathecae of C. elegans, an innovative protocol of polyethylene glycol embedding, ultra-sectioning, acridine orange staining, tissue identification by epifluorescence, and subsequent AFM-based ultrastructural data acquisition was applied. This sequence allowed the facile and fast assessment of the impact of quassinoid treatment not only on the gonadal but also on the considerably smaller spermathecal tissues of C. elegans. These first-time ultrastructural investigations on C. elegans gonads and spermathecae by AFM led to the identification of specific quassinoid-induced alterations to the nuclei of the reproductive tissues (e.g., highly condensed chromatin, impaired nuclear membrane morphology, as well as altered nucleolus morphology), altogether implying an apoptosis-like effect of ailanthone and bruceine A on the reproductive tissues of C. elegans.

Cross-sectional validity and specificity of comprehensive measurement in lymphedema and lipedema of the lower extremity: a comparison of five outcome instruments.

BACKGROUND: Literature on the validity of outcome measurement in lymphedema and lipedema is very sparse. This study aimed to examine the convergent, divergent and discriminant validity of a set of 5 instruments in both conditions. METHODS: Cross-sectional outcome was measured by the generic Short Form 36 (SF-36), the lymphedema-specific Freiburg Quality of Life Assessment for lymphatic disorders, Short Version (FLQA-lk), the knee-specific Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), the Symptom Checklist-90-revised (SCL-90R), and the Six-Minute Walk Test (6 MWT). Construct convergent/divergent validity was quantified by bivariate correlations and multivariate factor analysis, and discriminant validity by standardized mean differences (SMDs). RESULTS: Health was consistently better in lymphedema (n = 107) than in lipedema (n = 96). The highest construct convergence was found for physical health between the SF-36 and KOS-ADL (bivariate correlations up to 0.78, factor loads up to 0.85, explained variance up to 56.8%). The second most important factor was mental health (bivariate correlations up to 0.79, factor loads up to 0.86, explained variance up to 13.3%). Discriminant validity was greatest for the FLQA-lk Physical complaints (adjusted SMD = 0.93) followed by the SF-36 Bodily pain (adjusted SMD = 0.83), KOS-ADL Function (adjusted SMD = 0.47) and SF-36 Vitality (adjusted SMD = 0.39). CONCLUSIONS: All five instruments have specific strengths and can be implemented according to the scope and aim of the outcome examination. A minimum measurement set should comprise: the SF-36 Bodily pain, SF-36 Vitality, FLQA-lk Physical complaints, FLQA-lk Social life, FLQA-lk Emotional well-being, FLQA-lk Health state, KOS-ADL Symptoms, KOS-ADL Function, and the SCL-90R Interpersonal sensitivity.

Translation, cross-cultural adaptation and reliability of the German version of the migraine disability assessment (MIDAS) questionnaire.

BACKGROUND: The Migraine Disability Assessment (MIDAS) is a brief questionnaire and measures headache-related disability. This study aimed to translate and cross-culturally adapt the original English version of the MIDAS to German and to test its reliability. METHODS: The standardized translation process followed international guidelines. The pre-final version was tested for clarity and comprehensibility by 34 headache sufferers. Test-retest reliability of the final version was quantified by 36 headache patients completing the MIDAS twice with an interval of 48 h. Reliability was determined by intraclass correlation coefficients and internal consistency by Cronbach's α. RESULTS: All steps of the translation process were followed, documented and approved by the developer of the MIDAS. The expert committee discussed in detail the complex phrasing of the questions that refer to one to another, especially exclusion of headache-days from one item to the next. The German version contains more active verb sentences and prefers the perfect to the imperfect tense. The MIDAS scales intraclass correlation coefficients ranged from 0.884 to 0.994 and was 0.991 (95% CI: 0.982-0.995) for the MIDAS total score. Cronbach's α for the MIDAS as a whole was 0.69 at test and 0.67 at retest. CONCLUSIONS: The translation process was challenged by the comprehensibility of the questionnaire. The German version of the MIDAS is a highly reliable instrument for assessing headache related disability with moderate internal consistency. Provided validity testing of the German MIDAS is successful, it can be recommended for use in clinical practice as well as in research.

Quadriceps performance under activation of foot dorsal extension in healthy volunteers: an interventional cohort study.

BACKGROUND: The m. quadriceps femoris is the strongest muscle in the human body and plays an important role in sports, activities of daily living and independence. Two older studies showed increased electromyographic (EMG) activity of the quadriceps when the dorsal extensors of the foot were pre-activated. The aim was to physiologically replicate this finding by EMG and to verify it functionally by single leg hop. METHODS: EMG activity (root mean square, RMS) was tested on the leg press at the isometric load of the individual 12-repetition-maximum (12RM) weight (on average 79.7 kg) at 45° and 90° knee flexion. Single leg hop distance was measured between the tests. Intra-individual changes between with and without dorsal foot extension were quantified and compared by standardized response means (SRM). RESULTS: Thirty-five healthy subjects between 21 and 57 years were included. The m. vastus medialis was activated on average to an RMS of 32.4 µV without and 53.7 µV with dorsal foot extension (SRM = 1.39, p < 0.001) at 45° knee flexion and an RMS of 124.9 µV versus 152.8 µV (SRM = 1.08, p < 0.001) at 90°. The corresponding data for the rectus femoris were 9.4 µV versus 18.9 µV (SRM = 0.71, p < 0.001) at 45° and 77.8 µV versus 135.3 µV (SRM = 0.89, p < 0.001) at 90°. Mean single leg hop distance was 169.8 cm without versus 178.9 cm with dorsal foot extension (SRM = 1.09, p < 0.001). CONCLUSIONS: Pre-activation of dorsal foot extensors significantly increased EMG activity in the m. quadriceps femoris and single leg hop distance. It can therefore be used to improve functional quadriceps muscle performance and knee joint stability in training and rehabilitation.

Health and quality of life in patients with primary and secondary lymphedema of the lower extremity.

BACKGROUND: Little is known about comprehensively measured health and quality of life of lower limb lymphedema (LLL). The aim of this study was to determine health and quality of life of LLL patients stratified by primary and secondary lymphedema compared to a normative population-based data stratified by age, sex and comorbidity. PATIENTS AND METHODS: A cross-sectional study of patients after treatment at the department of angiology of a rehabilitation clinic was conducted. Self-assessment was performed by the Short Form 36 (SF-36) and two condition-specific measures. RESULTS: Primary LLL (n = 52) 75 % female, mean age 47.1 years) reported health comparable to normative values, e. g. SF-36 physical functioning 80.4 (norm 84.1, p = 0.512) and SF-36 vitality 62.7 (59.7, p = 0.117) (mean scores, 100 = best). Secondary LLL (n = 60, 68 % female, mean age 60.6 years) scored 68.1 (73.9, p = 0.049) and 55.2 (56.2, p = 0.800) on the corresponding scales. Mean symptoms and function scores on the specific measures ranged from 70.0 to 83.1 for primary LLL (100 = best) and from 63.3 to 80.6 for secondary LLL. Function, vitality and both SF-36 role dimensions were higher in primary LLL than in secondary LLL, (mean SF-36 vitality 62.7 versus 55.2, p = 0.035). CONCLUSIONS: Overall health and quality of life was high and comparable to the general population norms in primary LLL. The same was true for most psycho-social scales in secondary LLL whereas functionally some deficits were recorded. Cancer as the most frequent cause for secondary LLL may affect health in these dimensions. Reported negative effects of LLL seem to be well compensated, especially in primary LLL and under optimal treatment.

Multidimensional associative factors for improvement in pain, function, and working capacity after rehabilitation of whiplash associated disorder: a prognostic, prospective outcome study.

BACKGROUND: Whiplash associated disorders (WAD) have dramatic consequences for individual and public health. Risk factors for better and worse outcomes are important to optimize management. This study aimed to determine short- and mid-term associative co-factors of neck pain relief, improved physical functioning, and improved working capacity (dependent variables) in patients suffering from whiplash associated disorder who participated in a standardized, inpatient pain management program. METHODS: Naturalistic, observational, prospective cohort study. Outcome was measured by standardized assessment instruments. Co-factors covered sociodemographics, comorbidities, social participation, affective health, and coping abilities. Stepwise, multivariate linear regression analysis was performed at discharge and at the 6-month follow-up. RESULTS: All regression models explained high proportions of variance (53.3% - 72.1%). The corresponding baseline level was significantly associated with a change in every dependent variable (explained variances: 11.4%-56.7%). Pain relief significantly depended on improved function and vice-versa (3.4%-14.8%). Improved ability to decrease pain was associated with pain relief at discharge (9.6%). Functional improvement was associated with decreased catastrophizing (19.4%) at discharge and decreased depression (20.5%) at the 6 month follow-up. CONCLUSIONS: Pain relief, improved physical function and working capacity were associated with each other. Improved coping (catastrophizing and ability to decrease pain) and reduced depression may act as important predictors for pain relief and improved function. These findings offer toe-holds for optimized therapy of chronic WAD.

Effects of inpatient rehabilitation in hip and knee osteoarthritis: a naturalistic prospective cohort study with intraindividual control of effects.

OBJECTIVES: To quantify pain, function, and health-related quality of life in comparison with normative data, and to quantify intervention effects. DESIGN: Naturalistic cohort study without a control group. Correction of the effects observed during the intervention by those observed during waiting time prior to the intervention. SETTING: Inpatient rehabilitation clinic. PARTICIPANTS: Patients with hip (n=88) and knee (n=164) osteoarthritis. INTERVENTION: Comprehensive, multidisciplinary inpatient rehabilitation lasting 3 weeks. MAIN OUTCOME MEASURES: Medical Outcomes Study 36-Item Short-Form Health Survey and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). RESULTS: Four or more comorbid conditions had 45.3% of the hip and 51.8% of the knee patients on entry to and discharge from the clinic. On entry, physical health and some dimensions of psychosocial health were significantly diminished compared with population norms. At discharge, hip osteoarthritis had improved by a corrected effect size of .20 to .47 in pain, .04 to .39 in function, and -.04 to .32 in psychosocial health. Knee osteoarthritis showed a corrected effect size of .43 to .62 in pain, .19 to .51 in function, and .19 to .30 in psychosocial health. All but 1 effect in WOMAC pain and WOMAC function were higher than the minimal clinically important differences. CONCLUSIONS: Hip and knee osteoarthritis patients admitted to the inpatient intervention were affected by a substantial burden of disease and comorbidities. Inpatient rehabilitation resulted in small to moderate, statistically significant, and clinically important improvements in pain, function, and psychosocial health.

Association of the sense of coherence with physical and psychosocial health in the rehabilitation of osteoarthritis of the hip and knee: a prospective cohort study.

BACKGROUND: According to Antonovsky's salutogenic concept, a strong sense of coherence is associated with physical and psychological health. The goal of this study was to analyze the association of Antonovsky's sense of coherence with physical and psychosocial health components in patients with hip and knee osteoarthritis before and after in- and outpatient rehabilitation. METHODS: Prospective cohort study with 335 patients, 136 (41%) with hip and 199 (59%) with knee osteoarthritis. The outcome was measured by Short Form-36 (SF-36), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Sense of Coherence (SOC-13). Baseline scores of the SF-36 and WOMAC scales and the observed effect sizes after rehabilitation were correlated with the baseline SOC-13. These correlations of the SF-36 scales were compared to the Factor Score Coefficients for the Mental Component Summary of SF-36, which quantify the factor load on the psychosocial dimension. Predictive impact of the baseline SOC-13 for the SF-36 and WOMAC scales (baseline scores and effect sizes) was then determined by multivariate linear regression controlled for possible confounders. RESULTS: At baseline, the SOC-13 correlated with the WOMAC scores between r = 0.18 (stiffness) and r = 0.25 (pain) and with the SF-36 scores between r = 0.10 (physical functioning) and r = 0.53 (mental health). The correlation of these SF-36 correlation coefficients to the Factor Score Coefficient of the SF-36 Mental Component Summary was r = 0.95. The correlations for the effect sizes (baseline → discharge) with the baseline SOC-13 global score were all negative and varied between r = 0.00 (physical functioning) and r = -0.19 (social functioning). In the multivariate linear regression model, the explained variance of the SF-36 scores by the baseline SOC-13 increased continuously from physical to psychosocial health dimensions (from 12.9% to 29.8%). This gradient was consistently observed for both the baseline scores and the effect sizes. The results of the WOMAC were consistent with the physical health scales of SF-36. CONCLUSIONS: The sense of coherence was associated with psychosocial health dimensions but hardly with physical health. The higher the load of a scale on the psychosocial dimension the higher was its correlation to the sense of coherence. This is in contrast to the idea of Antonovsky who predicted high associations with both mental and physical health.

Relationship between subjectively-rated and objectively-tested physical function across six different medical diagnoses.

OBJECTIVE: To quantify and compare associations and relationships between self-rated and tested assessments of mainly mobility-related physical function in different diagnoses. DESIGN: Six longitudinal cohort studies before and after inpatient rehabilitation. PATIENTS: Patients with whiplash-associated disorder (n = 71), low back pain (n = 121), fibromyalgia (n = 84), lipoedema (n = 27), lymphoedema (n = 78), and post-acute coronary syndrome (n = 64). METHODS: Physical function was measured with the self-rated Short-Form 36 Physical functioning (SF-36 PF) and with the tested 6-Min Walk Distance (6MWD) and assessed by correlation coefficients. Across the 6 cohorts, the relationship between the 2 scores was compared using the ratio between them. RESULTS: The correlations between the 2 scores were mostly moderate to strong at baseline (up to r = 0.791), and weak to moderate for the changes to follow-up (up to r = 0.408). The ratios SF-36 PF to 6MWD were 1.143-1.590 at baseline and 0.930-3.310 for the changes, and depended on pain and mental health. CONCLUSION: Moderate to strong cross-sectional and moderate to weak longitudinal correlations were found between the 6MWD and the SF-36 PF. Pain and mental health should be considered when interpreting physical function. For a comprehensive assessment in clinical practice and research, the combination of self-rated and tested physical function measures is recommended.

Responsiveness of the cervical Northern American Spine Society questionnaire (NASS) and the Short Form 36 (SF-36) in chronic whiplash.

OBJECTIVE: To determine and compare the sensitivity to change of the condition-specific cervical Northern American Spine Society (NASS) and the generic Short Form 36 (SF-36). DESIGN: Prospective cohort study. SUBJECTS: One hundred and seventy five patients after whiplash injury. INTERVENTIONS: Four-week inpatient interdisciplinary pain management programme. MAIN MEASURES, ANALYSIS: Responsiveness of the NASS and the SF-36 was quantified by effect size and standardized response mean and compared within the same construct by the modified Jacknife test. Ability to detect improvement was compared using sensitivities determined from receiver operating characteristics curves. RESULTS: In pain, the NASS was comparable responsive to the SF-36 at the one-month follow-up (n = 175): effect sizes: 0.62 (NASS) versus 0.61 (SF-36), P = 0.914. The NASS was less responsive than the SF-36 in function: 0.23 versus 0.63, P < 0.001 and in pain+function: 0.35 versus 0.58 (P = 0.001). These relationships remained consistent using standardized response means, at the six-month follow-up (n = 103), and in the comparison of the sensitivities. Sensitivities at one month, pain: 70% (NASS) versus 62% (SF-36), P = 0.234; function: 65% versus 80%, P = 0.002; pain+function: 68% versus 78%, P = 0.035. The six-month data were similar. CONCLUSIONS: The generic SF-36 was more responsive in function and equally responsive in pain when compared to the condition-specific NASS. The SF-36 can be recommended as a responsive instrument for measurement of pain and function in chronic whiplash syndrome.

Reliability of the Multidimensional Pain Inventory and stability of the MPI classification system in chronic back pain.

BACKGROUND: This cross validation study examined the reliability of the Multidimensional Pain Inventory (MPI) and the stability of the Multidimensional Pain Inventory Classification System of the empirically derived subgroup classification obtained by cluster analysis in chronic musculoskeletal pain. Reliability of the German Multidimensional Pain Inventory was only examined once in the past in a small sample. Previous international studies mainly involving fibromyalgia patients showed that retest resulted in 33-38% of patients being assigned to a different Multidimensional Pain Inventory subgroup classification. METHODS: Participants were 204 persons with chronic musculoskeletal pain (82% chronic non-specific back pain). Subgroup classification was conducted by cluster analysis at 4 weeks before entry (=test) and at entry into the pain management program (=retest) using Multidimensional Pain Inventory scale scores. No therapeutic interventions in this period were conducted. Reliability was quantified by intraclass correlation coefficients (ICC) and stability by kappa coefficients (κ). RESULTS: Reliability of the Multidimensional Pain Inventory scales was least with ICC = 0.57 for the scale life control and further ranged from ICC = 0.72 (negative mood) to 0.87 (solicitous responses) in the other scales. At retest, 82% of the patients in the Multidimensional Pain Inventory cluster interpersonally distressed (κ = 0.69), 80% of the adaptive copers (κ = 0.58), and 75% of the dysfunctional patients (κ = 0.70) did not change classification. In total, 22% of the patients changed Multidimensional Pain Inventory cluster group, mainly into the adaptive copers subgroup. CONCLUSION: Test-retest reliability of the German Multidimensional Pain Inventory was moderate to good and comparable to other language versions. Multidimensional Pain Inventory subgroup classification is substantially stable in chronic back pain patients when compared to other diagnostic groups and other examiner-based subgroup Classification Systems. The MPI Classification System can be recommended for reliable and stable specification of subgroups in observational and interventional studies in patients with chronic musculoskeletal pain.

Horticultural therapy for patients with chronic musculoskeletal pain: results of a pilot study.

CONTEXT: Therapists can use horticultural therapy as an adjuvant therapy in a non threatening context, with the intent of bringing about positive effects in physical health, mental health, and social interaction. Very few experimental studies exist that test its clinical effectiveness. OBJECTIVE: To determine whether the addition of horticultural therapy to a pain-management program improved physical function, mental health, and ability to cope with pain. DESIGN: The research team designed a prospective, nonrandomized, controlled cohort study, enrolling all patients consecutively referred to the Zurzach Interdisciplinary Pain Program (ZISP) who met the studys criteria. The team divided them into two cohorts based on when medical professionals referred them: before (control group) or after (intervention group) introduction of a horticultural therapy program. SETTING: The setting was the rehabilitation clinic (RehaClinic) in Bad Zurzach, Switzerland. PARTICIPANTS: Seventy-nine patients with chronic musculoskeletal pain (fibromyalgia or chronic, nonspecific back pain) participated in the study. INTERVENTIONS: The research team compared a 4-week, inpatient, interdisciplinary pain-management program with horticultural therapy (intervention, n = 37) with a pain-management program without horticultural therapy (control, n = 42). The horticultural therapy program consisted of seven sessions of group therapy, each of 1-hour duration. OUTCOME MEASURES: The research team assessed the outcome using the Medical Outcome Study Short Form-36 (SF-36), the West Haven-Yale Multidimensional Pain Inventory (MPI), the Hospital Anxiety and Depression Scale (HADS), the Coping Strategies Questionnaire (CSQ ), and two functional performance tests. The team tested participants on entry to and discharge from the 4-week pain-management program. RESULTS: Between-group differences in sociodemographic and outcome variables were not significant on participants entry to the pain-management program. On discharge, the research team measured small to moderate outcome effects (effect size [ES] up to 0.71) within both groups. The study found significantly larger improvements for the horticultural therapy group vs the control group in SF-36 role physical (ES = 0.71 vs 0.22; P = .018); SF-36 mental health (ES = 0.46 vs 0.16; P = .027); HADS anxiety (ES = 0.26 vs 0.03; P = .043); and CSQ pain behavior (ES = 0.30 vs -0.05; P = .032). CONCLUSION: The addition of horticultural therapy to a pain management program improved participants' physical and mental health and their coping ability with respect to chronic musculoskeletal pain.

Catastrophizing as a prognostic factor for pain and physical function in the multidisciplinary rehabilitation of fibromyalgia and low back pain.

BACKGROUND: Quantitative data on longitudinal associations between catastrophizing and pain or physical function are patchy. The study aimed to quantify the prognostic value of catastrophizing for pain and function in fibromyalgia and low back pain before and after rehabilitation. METHODS: The associations of state and change on the Multidimensional Pain Inventory (MPI) Pain severity scale, the Short Form 36 (SF-36) Physical functioning scale and the Six-Minute Walking Distance (6MWD) with the Coping Strategies Questionnaire (CSQ) Catastrophizing scale were quantified by multiple regression modelling to adjust for confounders. RESULTS: Sex- and age-matched cohorts (n = 71 each) were compared. Pain and catastrophizing were worse in fibromyalgia than in low back pain, whereas the function levels were comparable. Baseline catastrophizing predicted pain change by adjusted correlations of 0.552 (fibromyalgia) and 0.450 (low back pain), self-rated function by 0.403 and 0.308, and the 6MWD by 0.270 and - 0.072. The change in catastrophizing was associated to the change in pain by 0.440 (fibromyalgia) and 0.614 (low back pain), self-rated function by 0.122 and 0.465, and the 6MWD by 0186 and 0.162. CONCLUSIONS: Catastrophizing (pain-related worrying) was a potential prognostic factor, especially for pain and somewhat less for self-rated physical function but it was only weakly predictive for the walking distance in both conditions, independently of potential confounders, such as sex, age, baseline severity and others. Reduction of maladaptive coping should be integrated into the management of chronic pain. SIGNIFICANCE: Our study showed surprisingly high associations between state and change in catastrophizing to pain relief and functional improvement in chronic pain patients. This is supported by clinical experience and research data, even if the construct and measurement of catastrophizing is under debate. Our findings and those of literature point to more pessimistic self-rating of pain and catastrophizing in fibromyalgia when compared to other conditions. This might obscure positive effects on pain and function achieved by adaptive coping in fibromyalgia.

Wen Dan Tang: A Potential Jing Fang Decoction for Headache Disorders?

BACKGROUND: Chinese herbal medicine is considered relatively safe, inexpensive, and easily accessible. Wen Dan Tang (WDT), a Jing Fang ancient classical Chinese herbal formula with a broad indication profile has been used for several centuries in China to treat various illnesses. QUESTION: Are there evidence-based clinical trials that show that WDT has a significant impact on the treatment of various diseases, especially in patients with migraine and tension-type headaches (TTH)? METHODS: This study is based on an online database search using PubMed, Medline, Cochrane Library, AcuTrials, Embase, Semantic Scholar, Jstor, internet research, and review of ancient and modern Chinese medical textbooks regarding WDT and its compounds. RESULTS: There were no studies on WDT in migraine and TTH; therefore, this work gathers and describes data for every single compound in the formula. CONCLUSION: This study suggests that the bioactive compounds found in WDT composition show potential in treating patients with neurological, psychiatric disorders, cardiovascular diseases, metabolic syndrome, and digestive disorders. Some coherence between WDT in headache reduction and improvements in the quality of life in patients with migraines and TTH could be evaluated, showing positive results of WDT in these patients.

Cultural adaption and multicenter validation of the German version of the LYMPH-Q Upper Extremity Module.

OBJECTIVE: Upper extremity lymphedema is a burdensome disease with significant effects on quality of life, underscoring the importance of quality of life measures for this patient population. Only recently, the LYMPH-Q Upper Extremity Module, a new patient-reported outcome measure, was developed. The aim of the present study was to translate the LYMPH-Q Upper Extremity Module from English to German and perform a comprehensive validation. METHODS: Translation was performed in accordance with the International Society for Pharmacoeconomics and Outcomes Research best practice guidelines. To validate the German LYMPH-Q, a multicenter study was conducted. Internal consistency was determined using Cronbach's α. Reliability was assessed using the intraclass correlation coefficient. To analyze construct validity, the Pearson correlation coefficient between the LYMPH-Q, quickDASH (disabilities of the arm, shoulder, and hand), and short-form 36-item health survey was calculated. Responsiveness was assessed by comparing the pre- and postoperative LYMPH-Q scores in five patients who had undergone lymphatic reconstructive surgery. RESULTS: Validation was performed using a cohort of 65 patients. The internal consistency of the different domains was good to excellent (α, 0.87-0.97). The intraclass correlation coefficient ranged from 0.74 to 0.92. The domains of the LYMPH-Q correlated significantly with the corresponding domains of the short-form 36-item health survey and quickDASH. Construct validity was good, with 8 of 10 hypotheses confirmed. Significant improvements in function (46.4 ± 13.3 vs 77.8 ± 11.5; P = .03), symptoms (42.0 ± 10.7 vs 70.6 ± 11.6; P = .02), and psychological well-being (40.4 ± 14.6 vs 78.0 ± 17.3; P = .03) were observed after lymphatic reconstructive surgery. CONCLUSIONS: The German version of the LYMPH-Q Upper Extremity Module was shown to be conceptually equivalent to the original English version. It was shown to be a reliable and valid patient-reported outcome measure to assess the physical and psychological impairments in patients with upper extremity lymphedema.

Comparison of Swiss versus Standard Acupuncture in Patients with Chronic Low Back Pain. A Study Protocol for a Randomized, Controlled, Single-Blind, Parallel Trial.

Introduction: Chronic low back pain (CLBP) cannot sufficiently be treated by pharmacological therapy and generates substantial health-care costs worldwide. Acupuncture, a cost-effective, safe and non-pharmacological therapy, has shown promising results in relieving acute low back pain; however, the optimal acupuncture therapy for CLBP remains controversial. This study will compare two acupuncture methods for pain relief in CLBP. Methods and Analysis: This randomized, controlled, single-blind, parallel trial will be conducted in patients with clinically diagnosed CLBP with a disease duration ≥3 months and an average pain intensity of ≥4 points on an 11-point Pain Intensity Numerical Rating Scale (pain-NRS) on the previous 7 days. Patients will be randomized to 9-week acupuncture therapy using Jiu Gong Points (termed Swiss low back acupuncture, SLBA) or standard acupuncture (SA) therapy (weeks 1-6: two sessions/week, weeks 7-9: one session/week, 15 sessions/patient in total). Measurements will be conducted before the first session (T1), at the end of the 9-week therapy (T2) and after 3- and 6-month follow-up (T3 and T4). The primary hypothesis is that 9 weeks of SLBA will be superior in reducing the pain severity assessed by the pain-NRS compared to SA therapy for CLBP. Secondary outcomes will be derived from the Short-Form 36, Oswestry Disability Index, Multidimensional Pain Inventory questionnaire, Symptom Checklist-90 - Revised questionnaire and a daily pain diary. Assuming a minimal clinically important difference in the pain-NRS of 0.39 and an effect size of ≥0.6 between SLBA and SA, 80% power, 0.05 alpha level and 20% dropouts, a total of 55 patients/arm will be required. The primary outcome will be analyzed in the intention-to-treat population using chained linear regression models. Patients, outcome assessors and data analysts will be blinded to the treatment arm. Trial Registration: Clinicaltrials.gov Identifier: NCT05232487.

Differences in pain, function and coping in Multidimensional Pain Inventory subgroups of chronic back pain: a one-group pretest-posttest study.

BACKGROUND: Patients with non-specific back pain are not a homogeneous group but heterogeneous with regard to their bio-psycho-social impairments. This study examined a sample of 173 highly disabled patients with chronic back pain to find out how the three subgroups based on the Multidimensional Pain Inventory (MPI) differed in their response to an inpatient pain management program. METHODS: Subgroup classification was conducted by cluster analysis using MPI subscale scores at entry into the program. At program entry and at discharge after four weeks, participants completed the MPI, the MOS Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale (HADS), and the Coping Strategies Questionnaire (CSQ). Pairwise analyses of the score changes of the mentioned outcomes of the three MPI subgroups were performed using the Mann-Whitney-U-test for significance. RESULTS: Cluster analysis identified three MPI subgroups in this highly disabled sample: a dysfunctional, interpersonally distressed and an adaptive copers subgroup. The dysfunctional subgroup (29% of the sample) showed the highest level of depression in SF-36 mental health (33.4 ± 13.9), the interpersonally distressed subgroup (35% of the sample) a modest level of depression (46.8 ± 20.4), and the adaptive copers subgroup (32% of the sample) the lowest level of depression (57.8 ± 19.1). Significant differences in pain reduction and improvement of mental health and coping were observed across the three MPI subgroups, i.e. the effect sizes for MPI pain reduction were: 0.84 (0.44-1.24) for the dysfunctional subgroup, 1.22 (0.86-1.58) for the adaptive copers subgroup, and 0.53 (0.24-0.81) for the interpersonally distressed subgroup (p = 0.006 for pairwise comparison). Significant score changes between subgroups concerning activities and physical functioning could not be identified. CONCLUSIONS: MPI subgroup classification showed significant differences in score changes for pain, mental health and coping. These findings underscore the importance of assessing individual differences to understand how patients adjust to chronic back pain.