Pain is not the major determinant of quality of life in fibromyalgia: results from a retrospective "real world" data analysis of fibromyalgia patients.

OBJECTIVE: To identify correlates of quality of life (QoL) measured with the Quality of Life Scale (QOLS) in participants of a multidisciplinary day hospital treatment program for fibromyalgia (FM). METHODS: In this cross-sectional, observational study, "real world" data from 480 FM patients including socio-demographics, pain variables and questionnaires such as the SF-36, Beck Depression Inventory (BDI), Multiphasic Pain Inventory (MPI), SCL-90-R and others were categorized according to the components (body structure and function, activities and participation, personal factors, environmental factors) of the International Classification of Functioning (ICF). For every ICF component, a linear regression analysis with QOLS as the dependent variable was computed. A final comprehensive model was calculated on the basis of the results of the five independent analyses. RESULTS: The following variables could be identified as main correlates for QoL in FM, explaining 56% of the variance of the QOLS (subscale/questionnaire and standardized beta in parenthesis): depression (- 0.22), pain-related interference with everyday life (- 0.19), general activity (0.13), general health perception (0.11), punishing response from others (- 0.11), work status (- 0.10), vitality (- 0.11) and cognitive difficulties (- 0.12). Pain intensity or frequency was not an independent correlate. CONCLUSIONS: More than 50% of QoL variance could be explained by distinct self-reported variables with neither pain intensity nor pain frequency playing a major role. Therefore, FM treatment should not primarily concentrate on pain but should address multiple factors within multidisciplinary therapy.

The Importance of Daily Activity for Reducing Fibromyalgia Symptoms: A Retrospective "Real World" Data Comparison of two Multimodal Treatment Programs.

OBJECTIVES: This study aims to evaluate the effectiveness of two multidisciplinary fibromyalgia programs with different intensities. MATERIALS AND METHODS: In this retrospective real-world comparison of patient data, pre- and post-program datasets of Short Form 36 (SF36) and Fibromyalgia Impact Questionnaire (FIQ) were obtained from a total of 210 female patients in two fibromyalgia multidisciplinary day hospital programs including one intensive program with daily treatments summing up to 20 treatment days during four weeks (P20, n=70) versus a less intensive program with 12 treatment days during four weeks (P12, n=140). RESULTS: Multiple subscales of SF36 and FIQ were improved in the pre-post comparison in both groups. In the comparison between the two groups, a statistically significantly higher improvement was found in the P20 group compared to the P12 group for the FIQ subscales of stiffness (p=0.001) and the number of days during which the patient felt "good" (p=0.007). CONCLUSION: An intensive program of daily treatments and activity seems to be more effective in reducing fibromyalgia-associated stiffness and improving the number of days during which patients feel good than a less intensive program.

Somatosensory profiles in acute herpes zoster and predictors of postherpetic neuralgia.

This prospective cohort study aimed to characterize the sensory profile during acute herpes zoster (AHZ) and to explore sensory signs as well as physical and psychosocial health as predictors for postherpetic neuralgia (PHN). Results of quantitative sensory testing of 74 patients with AHZ at the affected site and at the distant contralateral control site were compared to a healthy control group. Pain characteristics (Neuropathic Pain and Symptom Inventory and SES), physical functioning, and psychosocial health aspects (Pain Disability Index, SF-36, and STAI) were assessed by questionnaires. Patients with PHN (n = 13) at 6-month follow-up were compared to those without PHN (n = 45). Sensory signs at the affected site were thermal and vibratory hypesthesia, dynamic mechanical allodynia (DMA), pressure hyperalgesia, and high wind-up (18%-29%), as well as paradoxical heat sensations and pinprick hypalgesia (13.5%). The unaffected control site exhibited thermal and vibratory hypesthesia, DMA, and pressure hyperalgesia. Dynamic mechanical allodynia and pinprick hypalgesia were mutually exclusive. Postherpetic neuralgia was associated with DMA (38.5% vs 6.7%; P = 0.010) and vibratory hypesthesia (38.5% vs 11.1%; P = 0.036) at the control site, with mechanical gain and/or loss combined with normal thermal detection (affected site: 69.2% vs 31.1%; P = 0.023; control site: 53.8% vs 15.5%; P = 0.009). Pain Disability Index (P = 0.036) and SES affective pain perception scores (P = 0.031) were over 50% higher, and 6 of 8 SF-36 subscores were over 50% lower (P < 0.045) in PHN. Sensory profiles in AHZ indicate deafferentation and central but not peripheral sensitization. Sensory signs at distant body sites, strong affective pain perception, as well as reduced quality of life and physical functioning in the acute phase may reflect risk factors for the transition to PHN.

Acupuncture for Symptom Relief in Palliative Care-Study Protocol and Semistandardized Treatment Schemes.

The use of complementary and alternative medicine methods such as acupuncture in palliative care has increased over the past years. Well-planned trials are warranted to show its effectiveness in relieving distressing symptoms. The development of treatment schemes to be used in the trial for both acupuncture and medical symptom control is challenging, as both acupuncture and palliative care are highly individualized. Thus, standardized care plans of a randomized controlled trial will have difficulties in producing treatment results that compare to the clinical practice. As an alternative, treatment protocols for both acupuncture and medical symptom control of dyspnea, pruritus, hypersalivation, depression, anxiety, and xerostomia were designed with the input of experts. They are designed to provide sufficient symptom control and comparability for a three-arm, randomized controlled trial. Medical symptom control will be provided to all groups. The two control groups will be medical treatment and sham-laser acupuncture.

Hypnotic relaxation results in elevated thresholds of sensory detection but not of pain detection.

BACKGROUND: Many studies show an effectiveness of hypnotic analgesia. It has been discussed whether the analgesic effect is mainly caused by the relaxation that is concomitant to hypnosis. This study was designed to evaluate the effects of hypnotic relaxation suggestion on different somatosensory detection and pain thresholds. METHODS: Quantitative sensory testing (QST) measurements were performed before and during hypnosis in twenty-three healthy subjects on the dorsum of the right hand. Paired t-test was used to compare threshold changes. The influence of hypnotic susceptibility was evaluated by calculating correlation coefficients for threshold changes and hypnotic susceptibility (Harvard group scale). RESULTS: During hypnosis significantly changed somatosensory thresholds (reduced function) were observed for the following sensory detection thresholds: Cold Detection Threshold (CDT), Warm Detection Threshold (WDT), Thermal Sensory Limen (TSL) and Mechanical Detection Threshold (MDT). The only unchanged sensory detection threshold was Vibration Detection Threshold (VDT). No significant changes were observed for the determined pain detection thresholds (Cold Pain Thresholds, Heat Pain Thresholds, Mechanical Pain Sensitivity, Dynamic Mechanical Allodynia, Wind-up Ratio and Pressure Pain Threshold). No correlation of hypnotic susceptibility and threshold changes were detected. CONCLUSION: Hypnotic relaxation without a specific analgesic suggestion results in thermal and mechanical detection, but not pain threshold changes. We thus conclude that a relaxation suggestion has no genuine effect on sensory pain thresholds. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT02261155 (9th October 2014).

Impact of surgical intervention and postoperative pain on electrical skin resistance at acupuncture points: an exploratory study.

OBJECTIVES: One theory about acupuncture suggests that pathological processes can cause measurable changes in electrical skin resistance (ESR) at acupuncture points (APs). Although the theory has yet to be proven, ESR measurements (ESRMs) form a frequently used part of contemporary acupuncture. The aim of this study was to test the so-called 'electrical responsiveness' of APs in the setting of a defined operative trauma. METHODS: ESRMs (n=424) were performed at the APs and surrounding skin of GB34 and ST38 in 163 participants using an impedance meter array developed for the purpose of ESRMs. For each group the percentage of measurements with a significantly different ESR between the APs and the surrounding skin was calculated and compared with each other. Measurements of four groups were compared: healthy control subjects (n=30) and patients after ophthalmic (n=29), hip (n=42) and shoulder (n=30) surgery. The influence of postoperative pain intensity was also assessed. RESULTS: Group comparison showed no significant differences for ST38. The ESRMs at GB34 had a significantly higher percentage of measurements with an increased ESR after ophthalmic (23.2%) and hip (22.2%) surgery, but not after shoulder surgery (7.5%). Subgroup analysis showed that an increase in pain intensity tended to lead to a decrease in the number of APs with ESR changes. CONCLUSION: These results suggest that reactive changes in ESR at APs might exist. Pain and alertness seem to have an impact on ESR at APs. However, the current data do not allow for conclusions to be drawn concerning the clinical use of ESRMs.

Acupuncture point localization varies among acupuncturists.

BACKGROUND: Studies assessing the point-specific effect of acupuncture or the characteristics of acupuncture points (APs) tend to yield inconclusive results. In order to identify a possible confounding factor, we aimed to examine the variability in AP localization by means of a survey. MATERIAL AND METHODS: Attendees of the 14th ICMART (International Council of Medical Acupuncture and Related Techniques) congress as well as DÄGfA (German Medical Society of Acupuncture) lecturers and students were asked to locate and mark the APs LI 10 and TH 5 on a research assistant's arm. Identified points were transferred into a coordinate system, and the respective bivariate distribution function was calculated. Additionally, participants filled out a questionnaire about their acupuncture education and experience, the acupuncture style and point localization techniques used most frequently, and their estimation of the size of an AP. RESULTS: The areas of the ellipses, theoretically containing 95% of AP localizations, varied between 44.49 and 5.18 cm(2). The largest distance between 2 identified points was 8.45 cm for LI 10 and 5.3 cm for TH 5. Apart from being trained at the same school, no other factor could be identified that determined the variability in AP localization. CONCLUSION: Our results indicate that congruity of AP localization among experienced acupuncturists might be low. Although there are some limitations to our results, this possible bias should be taken into account when conducting acupuncture trials and interpreting results of previous acupuncture studies.

Etoricoxib--preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy--design and protocols.

BACKGROUND AND OBJECTIVE: Our objective was to report on the design and essentials of the Etoricoxib protocol- Preemptive and Postoperative Analgesia (EPPA) Trial, investigating whether preemptive analgesia with cox-2 inhibitors is more efficacious than placebo in patients who receive either laparotomy or thoracotomy. DESIGN AND METHODS: The study is a 2 x 2 factorial armed, double blinded, bicentric, randomised placebo-controlled trial comparing (a) etoricoxib and (b) placebo in a pre- and postoperative setting. The total observation period is 6 months. According to a power analysis, 120 patients scheduled for abdominal or thoracic surgery will randomly be allocated to either the preemptive or the postoperative treatment group. These two groups are each divided into two arms. Preemptive group patients receive etoricoxib prior to surgery and either etoricoxib again or placebo postoperatively. Postoperative group patients receive placebo prior to surgery and either placebo again or etoricoxib after surgery (2 x 2 factorial study design). The Main Outcome Measure is the cumulative use of morphine within the first 48 hours after surgery (measured by patient controlled analgesia PCA). Secondary outcome parameters include a broad range of tests including sensoric perception and genetic polymorphisms. DISCUSSION: The results of this study will provide information on the analgesic effectiveness of etoricoxib in preemptive analgesia and will give hints on possible preventive effects of persistent pain. TRIAL REGISTRATION: NCT00716833.

Acupuncture in acute herpes zoster pain therapy (ACUZoster) - design and protocol of a randomised controlled trial.

BACKGROUND: Acute herpes zoster is a prevalent condition. One of its major symptoms is pain, which can highly influence patient's quality of life. Pain therapy is limited. Acupuncture is supposed to soften neuropathic pain conditions and might therefore act as a therapeutic alternative. Objective of the present study is to investigate whether a 4 week semi-standardised acupuncture is non-inferior to sham laser acupuncture and the anticonvulsive drug gabapentine in the treatment of pain associated with herpes zoster. METHODS/DESIGN: Three-armed, randomised, placebo-controlled trial with a total follow-up time of 6 months. Up to estimated 336 patients (interim analyses) with acute herpes zoster pain (VAS > 30 mm) will be randomised to one of three groups (a) semi-standardised acupuncture (168 patients); (b) gabapentine with individualised dosage between 900-3600 mg/d (84 patients); (c) sham laser acupuncture. Intervention takes place over 4 weeks, all patients will receive analgesic therapy (non-opioid analgesics: metamizol or paracetamol and opioids: tramadol or morphine). Therapy phase includes 4 weeks in which group (a) and (c) consist of 12 sessions per patient, (b) visits depend on patients needs. Main outcome measure is to assess the alteration of pain intensity before and 1 week after treatment sessions (visual analogue scale VAS 0-100 mm). Secondary outcome measure are: alteration of pain intensity and frequency of pain attacks; alteration of different aspects of pain evaluated by standardised pain questionnaires (NPI, PDI, SES); effects on quality of life (SF 36); analgesic demand; alteration of sensoric perception by systematic quantitative sensory testing (QST); incidence of postherpetic neuralgia; side effects and cost effectiveness. Credibility of treatments will be assessed. DISCUSSION: This study is the first large-scale randomised placebo controlled trial to evaluate the efficacy of acupuncture compared to gabapentine and sham treatment and will provide valuable new information about the clinical and physiological effects of acupuncture and gabapentine in the treatment of acute herpes zoster pain. The study has been pragmatically designed to ensure that the study findings can be implemented into clinical practice if acupuncture can be shown to be an effective treatment strategy in acute herpes zoster pain. TRIAL REGISTRATION: NCT00885586.

Characteristics of electrical skin resistance at acupuncture points in healthy humans.

OBJECTIVES: The aim of this study was to evaluate the phenomenon of electrical skin resistance (ESR) changes at different acupuncture points (APs). SETTING: This single-blinded study was performed at the hospital of the University of Munich. DESIGN: Six common APs were measured (TE5, PC6, LU6, ST36, SP6, GB39) in 53 subjects. Subgroups were formed with varying time intervals for follow-ups (1 minute, 1 hour, 1 week) and a varying grade of reduction of the stratum corneum. METHODS: Electrical skin resistance measurements (ESRMs) were taken from a skin area of 6 x 6 cm using an array consisting of 64 (8 x 8) electrodes. The electrodes corresponding to the AP were located and the ESRM results were compared to those of the surrounding electrodes. The methodological setting made it possible to minimize major influence factors on electrical skin impedance measurements. RESULTS: A total of 631 ESRMs was evaluated: In 62.8% of the measured APs, no significant ESR difference was found. In 234 (37.2%) of the ESRMs, the ESR at the AP was significantly different from the surrounding skin area, with 163 (25.9%) points showing a lower and 71 (11.3%) points showing a higher ESR. Reproducibility was extremely high after 1 minute but was low after 1 hour and 1 week. CONCLUSIONS: This study shows that electrical skin resistance at APs can either be lower or higher compared to the surrounding area. The phenomenon is characterized by high short-term and low long-term reproducibility. Therefore, we conclude that APs might possess specific transient electrical properties. However, as the majority of the measured APs did not show a changed ESR, it cannot be concluded from our data that electrical skin resistance measurements can be used for acupuncture point localization or diagnostic/therapeutic purposes.

Impact of endovascular intervention on pain and sensory thresholds in nondiabetic patients with intermittent claudication: a pilot study.

UNLABELLED: Pain and sensory neuropathy are common in patients with peripheral arterial disease. So far it is unknown to what extent pain and sensory parameters can be ameliorated by endovascular intervention used to resolve the arterial obstruction. Seventeen nondiabetic patients with intermittent claudication were investigated in the present study. The patients had to undergo percutaneous transluminal angioplasty (PTA) to improve blood flow in the affected leg. To acquire detailed information of their sensory state quantitative sensory testing (QST) was performed before and 24 hours and 3 months after PTA. QST is a standardized clinical testing procedure for the detection of sensory changes that consists of multiple tests for thermal and mechanical detection and pain thresholds as well as vibratory thresholds and stimulus response functions. An age-matched control group was investigated with an interval of 3 months. Pain during exercise decreased by 60% (examined by numerical rating scale) after endovascular intervention, whereas the ankle/brachial-index-representing the peripheral hemodynamic situation-increased by 29%. Sensory function determined by QST did not change significantly following PTA over a 3-month period. Successfully performed PTA is highly effective in reducing exercise induced pain in patients with intermittent claudication. PERSPECTIVE: The study demonstrates that successfully performed PTA is a highly effective tool in reducing exercise induced pain in patients with intermittent claudication. However, the pain reduction observed cannot be verified by evaluating sensory functions using standardized quantitative sensory testing.

Changes in electrical skin resistance at gallbladder 34 (GB34).

OBJECTIVE: Electrodermal screening is widely used in the acupuncture community for point location, diagnosis and therapy. However the underlying theory that electrical skin resistance (ESR) of an area corresponding to an acupuncture point (AP) is lower than ESR of the surrounding areas is yet to be proven. The objective of this study was to evaluate and quantify the phenomenon of ESR changes at the Gallbladder 34 (GB34) Acupuncture Point (AP). MATERIALS AND METHODS: In this single-blinded study GB34 was measured bilaterally in 43 healthy volunteers. Electrical skin resistance measurements (ESRMs) were performed with a specially designed array consisting of 64 (8 x 8) electrodes on an area of 6 x 6 cm. Then the electrodes corresponding to the AP were identified and compared with those of the surrounding electrodes with Wilcoxon rank sum test. Values for p of less than 0.05 were considered statistically significant. RESULTS: Eighty-one ESRMs were evaluated. ESR was significantly different from the surrounding skin area in 27 (33.3%) cases with 15 (18.5%) points showing a lower and 12 (14.1%) points showing a higher ESR. CONCLUSION: This shows that ESR changes at APs exist in one third of the measured points, a very low rate for a postulation that forms the basis of various diagnosis and therapy systems.