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1.
Trials ; 20(1): 623, 2019 Nov 08.
Article in English | MEDLINE | ID: mdl-31703750

ABSTRACT

BACKGROUND: This study aims to evaluate the feasibility and efficacy of a complex health intervention, based on the combination of conventional Western medicine and traditional Chinese medicine (TCM), in an outpatient department of a university hospital for patients with frequent episodic or chronic tension-type headaches. METHODS/DESIGN: This is a prospective randomized controlled pilot study with four balanced treatment arms (usual care, acupuncture, training, and training plus acupuncture). Each arm will have 24 patients. After the initial screening examination and randomization, a 6-week treatment period follows, with treatment frequencies decreasing at 2-week intervals. After completion of the intervention, two follow-up evaluations will be performed 3 and 6 months after the start of treatment. At predefined times, the various outcomes (pain intensity, health-related quality of life, pain duration, autonomic regulation, and heart rate variability) as well as the participants' acceptance of the complex treatment will be evaluated with valid assessment instruments (Migraine Disability Assessment, PHQ-D, GAD-7, and SF-12) and a headache diary. The acupuncture treatment will be based on the rules of TCM, comprising a standardized combination of acupuncture points and additional points selected according to individual pain localization. The training therapy comprises a combination of strength training, endurance training, and training to improve flexibility and coordination. Besides descriptive analyses of the samples, their comparability will be assessed using an analysis of variance (ANOVA) or chi-squared tests. Analyses will be performed on an intention-to-treat basis. Potential interaction effects will be calculated using a repeated-measures ANOVA to test the primary and secondary hypotheses. In supplementary analyses, the proportion of treatment responders (those with a 50% reduction in the frequency of pain episodes) will be determined for each treatment arm. DISCUSSION: This trial may provide evidence for the additive effects of acupuncture and medical training therapy as a combination treatment and may scientifically support the implementation of this complex health intervention. TRIAL REGISTRATION: Registered on 11 Feburary 2019. German Clinical Trials Register, DRKS00016723.


Subject(s)
Acupuncture Therapy , Endurance Training , Randomized Controlled Trials as Topic , Resistance Training , Tension-Type Headache/therapy , Acupuncture Therapy/adverse effects , Adult , Combined Modality Therapy , Humans , Medicine, Chinese Traditional , Outcome Assessment, Health Care , Pilot Projects , Prospective Studies , Quality of Life , Tension-Type Headache/psychology
2.
Article in English | MEDLINE | ID: mdl-26865392

ABSTRACT

Skeletal-related events (SREs) including spinal cord compression, pathologic fracture, and radiation or surgery to bone, occur frequently due to bone metastases in advanced cancer. This analysis of a multicentre, observational study was designed to describe cross-regional differences in health resource utilisation (HRU) of SREs in Western Europe and the US. Patients with bone metastases due to breast, lung or prostate cancer, or multiple myeloma who had experienced a SRE within the past 97 days were enrolled. Investigators recorded HRU associated with SREs, including hospitalisation and length of stay (LOS), outpatient visits, procedures and bisphosphonate use. This subanalysis includes 668 patients with solid tumours (US, n = 190 with 354 SREs; EU, n = 478 with 893 SREs). The rate of SREs associated with hospitalisation(s) was higher in the EU vs. the US (30% vs. 15%, P < 0.001) and LOS was longer in the EU [mean (SD) days/SRE: 19.87 (17.31) vs. 10.61 (9.39)]. However, the US was associated with higher rate of SREs with outpatient visits than the EU (88% vs. 74%, P < 0.0001) and more procedures [mean (SD)/SRE: 11.26 (7.94) vs. 6.91 (6.48)]. Bisphosphonates were less often used in the EU (65% vs. 76% of US, P = 0.0033). In patients experiencing SREs due to bone metastases, HRU patterns reflect regional diversity with a substantial burden in both regions.


Subject(s)
Ambulatory Care/statistics & numerical data , Bone Density Conservation Agents/therapeutic use , Bone Neoplasms/complications , Diphosphonates/therapeutic use , Fractures, Spontaneous/etiology , Health Resources/statistics & numerical data , Hospitalization/statistics & numerical data , Spinal Cord Compression/etiology , Aged , Bone Neoplasms/secondary , Bone Neoplasms/therapy , Breast Neoplasms/pathology , Female , Germany , Humans , Italy , Length of Stay/statistics & numerical data , Lung Neoplasms/pathology , Male , Middle Aged , Orthopedic Procedures/statistics & numerical data , Prostatic Neoplasms/pathology , Radiotherapy/statistics & numerical data , Spain , United Kingdom , United States
3.
Complement Ther Med ; 9(2): 82-9, 2001 Jun.
Article in English | MEDLINE | ID: mdl-11444887

ABSTRACT

OBJECTIVES: The effectiveness of acupuncture treatment in patients with osteoarthritis of the hip was tested. DESIGN: This is a prospective, randomized, controlled, patient- and investigator-blinded clinical trial. PATIENTS AND SETTING: The study was performed at a university department for physical medicine and rehabilitation. Sixty-seven patients were separated into two treatment groups. INTERVENTIONS: Group 1 (treatment) had traditional needle placement and manipulation, whereas in group 2 (control) needles were placed away from classic positions and not manipulated. In both groups needles were placed within the L2 to L5 dermatomes. Outcome parameters were: pain (VAS), functional impairment (hip score), activity in daily life (ADL) and overall satisfaction before treatment, and 2 weeks and 2 months after treatment. RESULTS: For all parameters there was a significant improvement versus baseline in both groups 2 weeks and 2 months following treatment, but no significant difference between the two treatment groups. CONCLUSIONS: We conclude from these results that needle placement in the area of the affected hip is associated with improvement in the symptoms of osteoarthritis. It appears to be less important to follow the rules of traditional acupuncture techniques.


Subject(s)
Acupuncture Therapy/methods , Attitude to Health , Medicine, Chinese Traditional , Osteoarthritis, Hip/therapy , Patient Satisfaction , Activities of Daily Living , Acupuncture Therapy/adverse effects , Female , Humans , Male , Middle Aged , Pain Measurement , Patient Acceptance of Health Care
4.
Z Rheumatol ; 59(3): 191-9, 2000 Jun.
Article in German | MEDLINE | ID: mdl-10929448

ABSTRACT

OBJECTIVES: The effectiveness of acupuncture treatment in patients with osteoarthritis of the hip was tested. DESIGN: This is a prospective, randomized, controlled patient and examiner blinded clinical trial. PATIENTS AND SETTING: The study was performed at a university department for physical medicine and rehabilitation. Sixty-seven patients were separated into two treatment groups. INTERVENTIONS: Group 1 (treatment) had traditional needle placement and manipulation, whereas in group 2 (control) needles were placed away from classic positions and not manipulated. In both groups needles were placed within the L2 to L5 dermatomes. Endpoints were pain (VAS), functional impairment (hip score), activity of daily living (ADL) and overall satisfaction before treatment, 2 weeks and 2 months post-intervention. RESULTS: For all endpoints there was a significant improvement in both groups 2 weeks and 2 months following treatment versus baseline, but no significant difference between the two treatment groups. CONCLUSIONS: We conclude from these results that needle placement in the area of the affected hip by itself improves symptoms of osteoarthritis. It appears to be less important to follow the rules of traditional acupuncture techniques.


Subject(s)
Activities of Daily Living/classification , Acupuncture Therapy , Osteoarthritis, Hip/therapy , Pain Measurement , Acupuncture Points , Aged , Double-Blind Method , Female , Humans , Male , Middle Aged , Osteoarthritis, Hip/diagnosis , Patient Satisfaction , Prospective Studies , Treatment Outcome
5.
Arch Pathol Lab Med ; 115(6): 619-23, 1991 Jun.
Article in English | MEDLINE | ID: mdl-2039348

ABSTRACT

Erdheim-Chester disease is a rare pathologic entity characterized by symmetrical radiodensities in the metaphyseal and the diaphyseal portions of the long bones. Fibrosis, osteoblastic cortical bone deposition, and fibroxanthomatous granulomas with lipid-laden macrophages and multinucleated giant cells, which have a particular tropism for connective and adipose tissues, are the pathologic hallmarks. To our knowledge, 27 cases have been reported in the literature since the entity was first described in 1930. Protean clinical features range from a focal and asymptomatic process to a multisystemic infiltrative disease. We describe the clinical course of a new case and review the extensive pathologic findings at autopsy, including those demonstrated by light and electron microscopy and cytochemical and immunocytochemical studies.


Subject(s)
Bone Diseases/pathology , Adipose Tissue/pathology , Aged , Bone Diseases/complications , Bone and Bones/pathology , Connective Tissue/pathology , Diabetes Insipidus/complications , Diabetes Mellitus, Type 1/complications , Fibrosis , Heart Failure/complications , Humans , Immunoenzyme Techniques , Kidney Diseases/complications , Kidney Diseases/pathology , Lipid Metabolism , Macrophages/pathology , Male , Myocardial Infarction/complications , Testis/pathology , Xanthomatosis/complications
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