Abstract Background Against the background of widely inconsistent data from randomized controlled trials (RCT), the use of cannabis-based medicines (CBM) from the perspective of patients with chronic non-cancer pain (CNCP) was described. Methods Based on a purposive/convenient sampling, patients were recruited from the Pain Clinic of Hannover Medical School who had been using CBM prescribed by a doctor for at least 6 months. The patients discussed their experiences with CBM in semi-structured individual interviews. The interview transcripts were coded and analyzed using a modified grounded theory approach with the help of MAXQDA®. In addition, the Treatment Satisfaction Questionnaire with Medication (TSQM) was used. Results Theoretical saturation was reached after 32 interviews. Open and selective coding revealed the overarching phenomenon of “subjective pain experience under CBM therapy”, with one of the main themes being the “effect of CBM”. This revealed the categories “effect on pain” and “psychological” and “somatic effect”. The most important concepts were “pain intensity”, “pain management”, “stress management”, “musculoskeletal system”, and “sleep quality.” Constructing a theoretical framework 4 groups of responses to CBM treatment were identified. The focus is either on (I) pain reduction, (II) pain coping, (III) reduced stress or (IV) multidimensional aspects. When this classification was applied to topic of quality of life (QOL), the greatest effectiveness and highest overall satisfaction were found in group (IV). Mixed methods showed a continuous increase in the perceived effectiveness of CBM on pain-centered complaints from group (I) to (IV). Conclusions In line with the biopsychosocial understanding of chronic pain, it appears that those CNCP patients who benefit most from CBM are those who show the most far-reaching effects on both a physical and psychological level. The pleiotropic effects of CBM may be responsible for this. Based on these results, interdisciplinary prospective research appears sensible and necessary to further and systematically investigate this clinically relevant topic. Trial registration This study was registered with the German Clinical Trials Register (DRKS00037434), after approval by the local ethics committee (No. 8391_B0-K_2019).
Background: Adverse Childhood Experiences (ACEs) have been linked to long-term health consequences, including persistent, clinically relevant pain and psychological distress. This study investigates the prevalence and impact of ACEs among adults undergoing rehabilitation for persistent pain, focusing on their associations with pain, psychopathology, and treatment outcomes. Methods: We conducted a longitudinal cohort study with 324 inpatients enrolled in a 5-week interdisciplinary pain treatment at a psychosomatic-orthopedic rehabilitation center in Germany. Data were collected via questionnaires assessing ACEs, pain intensity, psychological distress, and well-being. The participants were categorized into three groups based on their ACEs: no ACEs, 1-3 ACEs, and four or more ACEs. Statistical analyses, including MANOVAs and regression analyses, were employed to examine the differences in psychological and pain-related distress and treatment outcomes among these groups. Results: The study found that 83.3% of participants reported at least one ACE, with 18.5% reporting four or more. Patients with more ACEs exhibited higher levels of depression, anxiety, stress, and pain-related incapability at the beginning of the treatment. While patients showed significant improvement in these measures by the end of the rehabilitation program, those with more ACEs continued to report higher levels of distress. Regression analyses indicated that specific ACEs, such as emotional abuse, significantly predicted higher levels of psychological distress and pain-related incapability. Conclusion: Patients with a history of multiple ACEs experience greater initial distress and require more comprehensive, trauma-informed and psychosomatically oriented care approaches to achieve optimal rehabilitation outcomes. Future research should focus on developing and evaluating tailored interventions that address the unique needs of this population.
Background: Chronic pain is a multifactorial condition for which interdisciplinary multimodal rehabilitation is guideline-recommended, yet the biological mechanisms underlying treatment response remain incompletely understood and validated predictive biomarkers have not been established. Objective: This exploratory prospective cohort study examined clinical outcomes and circulating biomarker changes, encompassing the endocannabinoid system (ECS), inflammatory mediators, stress-regulatory markers, and metabolic parameters, in 410 patients with chronic pain of predominantly musculoskeletal etiology undergoing a standardized five-week rehabilitation program. Materials and Methods: Pain intensity and affective pain were assessed at baseline and end of rehabilitation; global performance of treatment (GPT) was additionally recorded. Serum analyses included anandamide (AEA), 2-arachidonoylglycerol (2-AG), IL-6, cortisol, IGF-1, BDNF, and leptin. Biomarker-outcome associations were examined via multiple regression analyses adjusted for demographics and biological and clinical confounders. Results: Statistically significant reductions were observed in pain intensity (-0.785 points, NRS; p < 0.001) and affective pain (-0.750 points; p < 0.001). IL-6 was associated with pain outcomes across time points. Higher baseline 2-AG independently predicted lower end-of-rehabilitation pain intensity, affective pain, and more favorable GPT. Greater AEA reductions were associated with favorable GPT. Conclusions: Baseline 2-AG emerges as a candidate predictor of treatment response, with lower pre-treatment levels potentially reflecting reduced stress-adaptive capacity, supporting inclusion of ECS markers in future controlled biomarker studies.
Chronic low back pain (CLBP) affects over half a billion people worldwide. Current pharmacologic treatments, comprising mainly non-steroidal anti-inflammatory drugs and opioids, offer limited efficacy and pose significant risks, warranting the development of tolerable, safe and effective alternatives. This randomized controlled trial on adults with CLBP was designed to confirm the superior efficacy and gastrointestinal tolerability of VER-01, a novel, standardized full-spectrum extract from Cannabis sativa DKJ127 L., over opioids. Subjects were randomized (1:1) to receive VER-01 or a range of commercially available opioids. After a 3-week titration, subjects underwent 24 weeks of treatment, followed by 2 weeks of wash-out. The primary endpoint was the relative risk of constipation occurrence after 27 weeks treatment. Secondary endpoints included changes in pain and sleep scores, determined using an 11-point numeric rating scale (NRS), with key secondary endpoints defined for week 27. A total of 384 individuals were randomized to receive VER-01 (n = 192) or opioids (n = 192). Subjects receiving VER-01 were fourfold less likely to develop constipation than those receiving opioids (relative risk [RR] VER-01/opioids 0.25; 95
Chronic low back pain (CLBP) affects over half a billion people worldwide. Current pharmacologic treatments offer limited efficacy and carry substantial risks, warranting the development of safe and effective alternatives. This multicenter, randomized, placebo-controlled phase 3 trial evaluated the efficacy and safety of VER-01 in CLBP. It enrolled 820 adults with CLBP (VER-01, n = 394; placebo, n = 426) and included a double-blind 12-week treatment phase (phase A), a 6-month open-label extension (phase B), followed by either a 6-month continuation (phase C) or randomized withdrawal (phase D). The primary endpoint of phase A was a change in mean numeric rating scale (NRS) pain intensity, with a change in total neuropathic pain symptom inventory (NPSI) score as a key secondary endpoint in participants with a neuropathic pain component (PainDETECT > 18). The primary endpoint for phase D was time to treatment failure. The study met its primary endpoint in phase A, with a mean pain reduction of -1.9 NRS points in the VER-01 group (mean difference (MD) versus placebo = -0.6, 95% confidence interval (CI) = -0.9 to -0.3; P < 0.001). Pain further decreased to -2.9 NRS points in phase B, with effects sustained through phase C. The study also met its key secondary endpoint of phase A, with a mean NPSI decrease of -14.4 (standard error, 3.3) points from baseline in the VER-01 arm (MD versus placebo = -7.3, 95% CI = -13.2 to -1.3; P = 0.017). Although phase D did not meet its primary endpoint (hazard ratio = 0.75, 95% CI = 0.44-1.27; P = 0.288), pain increased significantly more with placebo upon withdrawal (MD = 0.5, 95% CI = 0.0-1.0; P = 0.034). In phase A, the incidence of adverse events-mostly mild to moderate and transient-was higher with VER-01 than with placebo (83.3% versus 67.3%; P < 0.001). VER-01 was well-tolerated, with no signs of dependence or withdrawal. VER-01 shows potential as a new, safe and effective treatment for CLBP. ClinicalTrials.gov registration: NCT04940741 .
Objectives To examine the effects of acupuncture and therapeutic exercise alone and in combination on temporomandibular joint symptoms in tension-type headache and to evaluate the potential interaction of existing temporomandibular dysfunction on the success of headache treatment. Design Pre-planned secondary analysis of a randomized controlled, non-blinded trial. Setting Outpatient clinic of a German university hospital. Subjects Ninety-six Participants with frequent episodic or chronic tension-type headache were randomized to one of four treatment groups. Interventions Six weeks of acupuncture or therapeutic exercise either as monotherapies or in combination, or usual care. Follow-up at 3 and 6 months. Main measures Subjective temporomandibular dysfunction symptoms were measured using the Functional Questionnaire Masticatory Organ, and the influence of this sum score and objective initial dental examination on the efficacy of headache treatment interventions was analyzed. Results Temporomandibular dysfunction score improved in all intervention groups at 3-month follow-up (usual care: 0.05 [SD 1.435]; acupuncture: −5 [SD 1.436]; therapeutic exercise: −4 [SD 1.798]; combination: −3 [SD 1.504]; P = 0.03). After 6 months, only acupuncture (−6 [SD 1.736]) showed a significant improvement compared to the usual care group ( P < 0.01). Subjective temporomandibular dysfunction symptoms had no overall influence on headache treatment. Conclusions Only acupuncture had long-lasting positive effects on the symptoms of temporomandibular dysfunction. Significant dental findings seem to inhibit the efficacy of acupuncture for tension-type headache.
Background: Symptom validity tests (SVTs) and performance validity tests (PVTs) are important tools in sociomedical assessments, especially in the psychosomatic context where diagnoses mainly depend on clinical observation and self-report measures. This study examined the relationship between reaction times (RTs) and scores on the Structured Inventory of Malingered Symptomatology (SIMS). It was proposed that slower RTs and larger standard deviations of reaction times (RTSDs) would be observed in participants who scored above the SIMS cut-off (>16). Methods: Direct surface electromyography (EMG) was used to capture RTs during a computer-based RT test in 152 inpatients from a psychosomatic rehabilitation clinic in Germany. Correlation analyses and Mann-Whitney U were used to examine the relationship between RTs and SIMS scores and to assess the potential impact of covariates such as demographics, medical history, and vocational challenges on RTs. Therefore, dichotomized groups based on each potential covariate were compared. Results: Significantly longer RTs and larger RTSDs were found in participants who scored above the SIMS cut-off. Current treatment with psychopharmacological medication, diagnosis of depression, and age had no significant influence on the RT measures. However, work-related problems had a significant impact on RTSDs. Conclusion: There was a significant relationship between longer and more inconsistent RTs and indicators of exaggerated or feigned symptom report on the SIMS in psychosomatic rehabilitation inpatients. Findings from this study provide a basis for future research developing a new RT-based PVT.
Chronic pain is primarily conceptualized as a disease in its own right when it is associated with emotional distress and functional impairment. Pathophysiologically, dysfunction of the cortico-mesolimbic connectome is of major importance, with overlapping signals in the nociceptive and stress systems. The endocannabinoid system plays an important role in the central processing of nociceptive signals and regulates the central stress response. Clinically, there is moderate evidence that cannabis-based medicines (CBM) can contribute to a significant reduction in pain, especially the associated pain affect, and improvement in physical function and sleep quality in a proportion of patients with chronic pain. The analgesic effect appears to be largely independent of the cause of pain. In this context, CBM preferentially regulates stress-associated pain processing.
Background and objective Psychometric tests can provide important information for diagnostics and progression in chronic pain patients. Between 2008 and 2018, the electronic system painDETECT (R) was used in the outpatient pain clinic of the Hannover Medical School (MHH). The aim of this retrospective study was to evaluate the pain symptomatology data recorded using painDETECT (R) and the treatment procedures used in the patient cohort examined over a period of 15 months. Material and methods A statistical analysis of baseline and follow-up data was performed. The analysis comprised pain-related parameters recorded by use of the painDETECT (R) system as well as outpatient records. Results Baseline data of 459 patients (66% women) could be evaluated. The most common clinical pictures were spinal pain, headache, facial pain, and somatoform disorders, mostly with many years of previous treatment. Approximately 40% showed evidence of neuropathic pain components or central sensitization. With a mean pain intensity of VAS 6 (0-10), a predominantly high degree of chronicity was present. Approximately one third showed a high degree of pain-related functional impairment. Slightly more than half showed evidence of clinically relevant depression. Approximately 80% showed clinically relevant sleep disturbances. Follow-up data were available for 145 patients (31.6%). The proportion of patients receiving a nonpharmacological form of treatment increased by 44.1% (physical therapy) and by 24.1% (psychotherapeutic procedures) during the observation period. The use of co-analgesics increased by approximately 30% over the course. Conclusion In the outpatient setting, an extension of treatment can be successful for high-grade chronic pain patients. Close structural networking with the clinics for rehabilitation medicine and for psychosomatics and psychotherapy at the MHH can be a favorable prerequisite for this.
Brandon C. Yarns, MD, MS; Nicholas J. Jackson, PhD, MPH; Alexander Alas, AA; Rebecca J. Melrose, PhD; Mark A. Lumley, PhD; David L. Sultzer, MD
BACKGROUND:Extensive audio-motor training and psychological stress can cause professional musicians acute overstrain-injury and chronic pain, resulting in damaged careers and diminished quality of life. It has also been previously shown that musicians might perceive pain differently than non-musicians. Therefore, the aim of our study was to quantify differences between musicians and non-musicians regarding their subjective responses to painful contact heat stimuli and assess how emotional traits might influence these responses. METHODS:Upon completing the StateTrait-Anxiety-Depression Inventory, 15 healthy musicians and 15 healthy non-musicians from German universities received 15 noxious contact heat stimuli at the dorsal side of each hand and foot. After each stimulation, participants were asked to provide a pain rating from 0 to 10. RESULTS:Musicians not only reported significantly higher pain ratings after the first stimulation but also showed a significantly higher degree of habituation compared to non-musicians. Additionally, musicians showed a significantly less pronounced difference regarding the pain rating of the hands compared to the feet than non-musicians. Trait anxiety and trait depression scores had no effect on the pain rating or the habituation. CONCLUSION:The more pronounced habituation of musicians might hint at a neuroplastic nociceptive alteration in musicians. The lack of significance between the psychological traits and their effect on the pain ratings is surprising but could be a result of both participant groups having stressful careers. SIGNIFICANCE:The findings of this report justify musicians' repetitive sensorimotor training as an important model for plasticity and contribute to a better understanding of pain perception in musicians.
Objectives To compare the effects of acupuncture and medical training therapy in combination or individually with usual care on quality of life, depression, and anxiety in patients with tension-type headache. Methods In this single-center, prospective, randomized, controlled, unblinded trial, 96 adults (38.7(+/−13.3) years of age; 75 females/20 males/one dropout) with frequent episodic or chronic tension-type headache were randomized to one of four treatment groups (n = 24). The treatment groups received six weeks of either acupuncture or medical training therapy as monotherapies or in combination (12 interventions each), or usual care. We assessed depressiveness (PHQ-9), anxiety (GAD-7), and health-related quality of life (SF-12) as secondary outcome parameters at baseline, six weeks, three months, and six months after initiation of treatment. Linear mixed models were calculated. Results Both, acupuncture (baseline to six-weeks change scores: mean: −2(standard deviation: 2.5 points), three months: −2.4(2.4), six-months −2.7(3.6)) and the combination of acupuncture and medical training therapy (−2.7(4.9), −2.2(4.0), −2.2(4.2)) (each within-group p < .05) significantly reduced depressiveness-scores (PHQ-9) to a greater extent than medical training therapy (−0.3(2.0), −0.5(1.6), −0.9(2.6)) or usual care alone (−0.8(2.9), 0.1(2.8), 0.2(3.6)). We found similar results with anxiety scores and the physical sum scores of the SF-12. No severe adverse events occurred. Conclusions Acupuncture and the combination of acupuncture and medical training therapy elicit positive effects on depression, anxiety, quality of life, and symptom intensity in patients with episodic and chronic tension-type headache. Acupuncture appears to play a central role in mediating the therapeutic effects, underscoring the clinical relevance of this treatment. An additive benefit of the combination of both therapies does not appear to be relevant. Trial registration: Registered on 11 February 2019. German Clinical Trials Register, DRKS00016723.
IntroductionSince cannabinoids were partially legalized as prescription medicines in Germany in 2017, they are mostly used when conventional therapies do not suffice. Ambiguities remain regarding use, benefits and risks. This web-based survey explored the perspectives of patients whose experiences are not well enough known to date.MethodsIn an anonymous, exploratory, cross-sectional, one-time web-based observational study, participants receiving cannabinoid therapy on prescription documented aspects of their medical history, diagnoses, attitudes toward cannabinoids, physical symptoms, and emotional states. Participants completed the questionnaires twice here: first regarding the time of the survey and then, retrospectively, for the time before their cannabinoid therapy. Participants were recruited in a stratified manner in three German federal states.ResultsN = 216 participants (48.1% female, aged 51.8 ± 14.0) completed the survey, most of which (72%, n = 155) reported pain as their main reason for cannabinoid therapy. When comparing the current state with the retrospectively assessed state, participants reported greater satisfaction with their overall medical therapy (TSQM II: +47.9 ± 36.5, p < 0.001); improved well-being (WHO-5: +7.8 ± 5.9, p < 0.001) and fewer problems in PROMIS subscales (all p < 0.001). Patients suffering primarily from pain (72%, n = 155) reported a reduction of daily pain (NRS: −3.2 ± 2.0, p < 0.001), while participants suffering mainly from spasticity (8%, n = 17) stated decreased muscle spasticity (MSSS: −1.5 ± 0.6, p < 0.001) and better physical mobility (−0.8 ± 0.8, p < 0.001). Data suggests clinically relevant effects for most scores. Participants’ attitudes toward cannabinoids (on a 5-point scale) improved (+1.1 ± 1.1, p < 0.001). Most patients (n = 146, 69%) did not report major difficulties with the cannabinoid prescription process, while (n = 27; 19%) had their cannabinoid therapy changed due to side effects.DiscussionMost participants experienced their therapy with cannabinoids as more effective than their previous therapy. There are extensive limitations to this cross-sectional study: the originally intended representativeness of the dataset was not reached, partly due to the SARS-CoV-2 pandemic; the sample has a larger proportion of privately insured and self-paying patients. Results does not suggest that cannabinoid patients belong to a particular clientele. Effect sizes observed for pain reduction, quality of life, social participation, and other outcomes suggest a therapeutic potential, particularly in the treatment of chronic pain.
BACKGROUND:Medical cannabinoids are controversial. Their use is comparatively rare, but it is rising. Since 2017, cannabinoids can be prescribed in Germany for a broader range of indications. Patient surveys on these drugs are hampered by the stigmatization of cannabinoids and their (still) low prevalence in medical contexts. Against this background, patients' willingness to provide information is limited. Moreover, it is logistically challenging to reach them with a survey. A thorough knowledge of currently ongoing therapies and their effects and side effects, however, is important for a more appropriate and effective use of cannabinoids in the future.OBJECTIVE:This study is an exploratory data collection using a representative sample. The main goal is to provide a detailed picture of the current use of medical cannabinoids in Germany. It is intended to identify subgroups that may benefit particularly well or poorly.METHODS:We are conducting a representative, anonymous, cross-sectional, one-time, web-based survey based on mixed methods in 3 German federal states. Health conditions under cannabinoid therapy and before are documented with validated, symptom-specific questionnaires. This allows an estimation of the effect sizes of these therapies. The selection of parameters and questionnaires was based on the results of independent qualitative interviews in advance. Representative samples of the hard-to-reach study population are obtained by cluster sampling via contracted physicians of the statutory health insurance companies.RESULTS:Recruitment was ongoing until the end of June 2022, with 256 enrolled participants. Validated questionnaires on pain, spasticity, anorexia or wasting, multiple sclerosis, nausea or vomiting, depression, and attention deficit hyperactivity disorder (ADHD) were selected. Symptom scores are being assessed for both current conditions under cannabinoid therapy and conditions prior to this therapy (in retrospect). Validated questionnaires are also used for treatment satisfaction and general quality of life. These are supplemented by existing diagnoses, a detailed medication history, any previous experiences with cannabis or illegal substances, experiences with the prescription process, and sociodemographic data. Based on the results of the previous qualitative interviews, questions were added regarding prior experience with relaxation methods and psychotherapy, personal opinions about cannabinoids, pre-existing or symptom-related psychological trauma, and different experiences with different cannabis-based therapies.CONCLUSIONS:The exploratory mixed methods approach of this project is expected to provide valid and relevant data as a basis for future clinical research. The study design may be representative for a large proportion of outpatients treated with cannabinoids in the German federal states studied. It may have less bias toward social desirability and may provide valuable information in addition to existing studies. Due to the observational and cross-sectional nature of this study, various limitations apply. Causal relations cannot be drawn.TRIAL REGISTRATION:German Clinical Trials Register DRKS00023344; https://drks.de/search/en/trial/DRKS00023344.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/38814.
Persistent Genital Arousal Disorder (PGAD) is a rare condition—mostly in women—where patients perceive prolonged genital arousal without any sexual desire or stimulation. Etiopathological considerations reach from peripheral to central issues over local disturbance of the pudendal nerve to neuropathy, psychosocial, and pharmacological theories. Since well controlled clinical studies about PGAD in conjunction with a mental and somatic health status are missing, this study is a detailed clinical investigation of PGAD patients compared to healthy controls. 26 women who fulfilled diagnostic criteria for PGAD were compared to 26 age matched healthy controls. Investigations included comparison of vegetative, gynaecological and sexual history, psychiatric features as well as a (neuro-)radiological, neurophysiological and gynaecological examination. Moreover, a detailed clinical characterisation of PGAD symptoms was performed. PGAD symptoms were mostly characterised as tingling or prickling and were permanently present. In over 80%, PGAD symptoms were located in the clitoris. Almost 70% reported radiations to other regions of the body. Most frequent trigger factors were tight clothes, mental stress, driving a car/bus/bicycle and sexual intercourse. Relieving factors were mainly distraction, relaxation, physical exercise, masturbation and swimming. In group comparisons, PGAD presented with significant higher rates of sexual dysfunctions, spontaneous orgasms, swelling of the genitals, extraordinary lubrication as well as higher rates in depression, agoraphobia, generalized anxiety disorder and lifetime panic disorder. Significantly more PGAD patients were diagnosed with restless legs symptoms. In contrast childhood traumatization, somatization disorder, suicidality, gynaecological as well as neurophysiological examination of the pudendal nerve were not different between the groups. MRI of the brain, pelvis and spinal cord was unsuspicious and incidental findings - including Tarlov cysts or pelvic venous congestion - were equally distributed among the groups. In summary, our study provides a careful characterization of women with PGAD highlighting a serious mental burden, most probably as a consequence of PGAD. With the current set of clinical investigations there was no evidence of a clear causal relationship to a specific clinical finding as it has been previously discussed. Future studies and additional techniques will have to further explore where and how in the peripheral or central nervous systems PGAD develops.
ObjectivePosttraumatic stress disorder (PTSD) and traumatic life events are often coupled to chronic pain, possibly linked by central sensitization. We wanted to assess the prevalence of traumatic events and PTSD in chronic pain patients of a German university hospital outpatient pain clinic. Moreover, we evaluated the extent of indicators and co-occurring traits of central sensitization in comorbid patients.MethodsWe retrospectively divided 914 chronic pain patients into four groups depending on their trauma severity: no trauma, accidental trauma, interpersonal trauma, and PTSD. We collected electronic pain drawings focusing on pain area and widespreadness, as well as information about pain intensity, sleep impairment, disability, stress, anxiety, depression, and somatization. Differences between groups were calculated using Kruskal-Wallis with post-hoc Mann-Whitney tests.ResultsOf 914 patients, 231 (25%) had no trauma, 210 (23%) had accidental traumas, 283 (31%) had interpersonal traumas, 99 (11%) had PTSD, and 91 (10%) could not be classified. We observed statistically significant differences between groups in pain area and widespreadness, as well as maximal pain, sleep impairment, disability, stress, anxiety, depression, and somatization. The severity of symptoms increased with trauma severity.ConclusionsTraumatic life events and PTSD are frequent in chronic pain patients. The increased pain area and widespreadness, as well as the increased negative impact on co-occurring traits of sensory sensitivity (anxiety, depression, somatization), are compatible with central sensitization in comorbid patients. Therefore, a heightened awareness of the comorbidity between traumatic experiences and chronic pain is recommended.
Background: In the course of the legalization of cannabis for therapeutic purposes in Germany, there has been growing interest in the medical use of cannabinoids. To date, the therapeutic potential of cannabinoids for the treatment of critically ill patients has not been explored. Objectives: This study aims to understand better whether and how frequently cannabinoids have been administered to critically ill patients in recent years. Study Design: Initially, a survey was conducted among physicians working in intensive care units (ICUs) at the Hannover Medical School. Subsequently, 653 physicians working in ICUs throughout Germany were surveyed. The frequency and regimen of cannabinoid therapy initiated by the participating physicians in the last 2 years at the time of the survey were characterized. Results: Eight out of 9 physicians at Hannover Medical School and 59 out of 653 physicians in ICUs in Germany participated. At Hannover Medical School, 6 out of 8 physicians and in ICUs in Germany, 16 out of 59 physicians had used cannabinoids in some patients (mainly 9-10) during the 2-year period studied, with dronabinol in doses between 1 and 20 mg being their cannabinoid of choice. Metabolic and psychological distress and medication savings, followed by pain and nausea/vomiting, were the most frequently cited indications for cannabinoid therapy. No relevant safety issues arrived. Lack of personal experience, limited evidence, and gaps in knowledge were the most commonly cited reservations about cannabinoid use. Conclusions: During a 2-year period, dronabinol is used in a few critically ill patients in ICUs. The main indications are to reduce metabolic and psychological distress and to save medication. The majority of participating physicians indicated that the use of cannabinoids in the context of critical care medicine needs further exploration.
Background The consensus for the optimal treatment strategy for chronic Achilles tendinopathy (AT) is still debated and treatment options are limited. This results in a significant medical need for more effective treatment options. Objective The aim of this study is to investigate the therapeutic effects of percutaneous bioelectric current stimulation (PBCS) on AT. Methods A multicenter, randomized, double-blind, placebo-controlled clinical trial will be conducted. A total of 72 participants with chronic (ie, >3 months) midpoint AT will be randomized and receive four PBCS sessions—either verum or placebo—over 3 weeks. Both groups will complete daily Achilles tendon loading exercises in addition to the intervention. Evaluation sessions will be completed at baseline and during the intervention (weeks 0-3). Self-reported outcome measures will be completed at follow-up at weeks 4, 12, 26, and 52. The primary outcomes are the Victorian Institute of Sports Assessment–Achilles questionnaire scores and statistical evaluation of intraindividual differences between baseline and 12-week evaluations after initial treatment of verum therapy compared to control. Secondary outcomes will assess Pain Disability Index scores; average pain, using the 11-point Numeric Rating Scale; return to sports; and use of emergency medication. Results The study began in May 2021. As of October 2022, we randomized 66 out of 72 participants. We anticipate completing recruitment by the end of 2022 and completing primary data analysis by March 2023. Conclusions The study will evaluate the effects of PBCS on pain, physical function, and clinical outcomes. Trial Registration German Clinical Trials Register DRKS00017293; https://tinyurl.com/mvz7s98k International Registered Report Identifier (IRRID) DERR1-10.2196/40894