Study Results
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Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2020-02-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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massage-electroacupuncture
Electroacupuncture will be applied throughout the back of the body, upper limbs and ears.Massage will follow the same paths of acupuncture points respectively
Electroacupuncture device
The technical characteristics of the device will be: power supply with alkaline batteries (4 pieces), 6V voltage, 6 independently regulated channels, symmetrical biphasic rectangular pulse, excitation from pen type electrode 0.48mA, with high 0.32mA + / -25% \& low 0.16mA +/- 25%. Three preset programs to avoid tolerance effect: program 1) 1-6Hz, program 2) 30-100Hz, program 3) 2-100Hz. Low frequencies (2Hz) cause release of endorphins in the brain and enkephalins in the spinal cord, high frequencies (30-100Hz) cause release of dynorphins in the spinal cord, while medium frequencies (15Hz) cause simultaneous release of endorphin and dynorphin. At low frequencies slow diffuse analgesia is achieved with a long duration of analgesic effect, while at high frequencies rapid local analgesic effect of short duration is achieved.
Epidural analgesia
Epidural analgesia will be applied using lidocaine 2%, 1.5 ml, and Dexamethasone 8 mg
Epidural analgesia
Epidural analgesia with lidocaine 2%, 1.5 ml, and Dexamethasone 8 mg
Interventions
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Electroacupuncture device
The technical characteristics of the device will be: power supply with alkaline batteries (4 pieces), 6V voltage, 6 independently regulated channels, symmetrical biphasic rectangular pulse, excitation from pen type electrode 0.48mA, with high 0.32mA + / -25% \& low 0.16mA +/- 25%. Three preset programs to avoid tolerance effect: program 1) 1-6Hz, program 2) 30-100Hz, program 3) 2-100Hz. Low frequencies (2Hz) cause release of endorphins in the brain and enkephalins in the spinal cord, high frequencies (30-100Hz) cause release of dynorphins in the spinal cord, while medium frequencies (15Hz) cause simultaneous release of endorphin and dynorphin. At low frequencies slow diffuse analgesia is achieved with a long duration of analgesic effect, while at high frequencies rapid local analgesic effect of short duration is achieved.
Epidural analgesia
Epidural analgesia with lidocaine 2%, 1.5 ml, and Dexamethasone 8 mg
Eligibility Criteria
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Inclusion Criteria
* Age 20 to 65 years
Exclusion Criteria
* Neoplasms (benign or malignant etiology)
* Contagious or infectious disease
* Dermopathy
* Pregnancy
* Alcohol or drug use
* Previous use of epidural analgesia
* Systemic opioid use
* Severe heart disease
* Fever for more than one sessions
* Allergy to the oil which will be used and its derivatives
* Thrombi or varicose veins
* Psychiatric disease
20 Years
65 Years
ALL
No
Sponsors
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University of Thessaly
OTHER
Responsible Party
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Elena Arnaoutoglou
Professor of Anesthesiology
Locations
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University Hospital of Larisa, Department of Anesthesiology
Larissa, Thessaly, Greece
University Hospital of Larissa
Larissa, Thessaly, Greece
Countries
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References
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Andrianakos A, Trontzas P, Christoyannis F, Dantis P, Voudouris C, Georgountzos A, Kaziolas G, Vafiadou E, Pantelidou K, Karamitsos D, Kontelis L, Krachtis P, Nikolia Z, Kaskani E, Tavaniotou E, Antoniades C, Karanikolas G, Kontoyanni A; ESORDIG Study. Prevalence of rheumatic diseases in Greece: a cross-sectional population based epidemiological study. The ESORDIG Study. J Rheumatol. 2003 Jul;30(7):1589-601.
Diatchenko L, Anderson AD, Slade GD, Fillingim RB, Shabalina SA, Higgins TJ, Sama S, Belfer I, Goldman D, Max MB, Weir BS, Maixner W. Three major haplotypes of the beta2 adrenergic receptor define psychological profile, blood pressure, and the risk for development of a common musculoskeletal pain disorder. Am J Med Genet B Neuropsychiatr Genet. 2006 Jul 5;141B(5):449-62. doi: 10.1002/ajmg.b.30324.
Diego MA, Field T, Sanders C, Hernandez-Reif M. Massage therapy of moderate and light pressure and vibrator effects on EEG and heart rate. Int J Neurosci. 2004 Jan;114(1):31-44. doi: 10.1080/00207450490249446.
Fang JQ, Du JY, Fang JF, Xiao T, Le XQ, Pan NF, Yu J, Liu BY. Parameter-specific analgesic effects of electroacupuncture mediated by degree of regulation TRPV1 and P2X3 in inflammatory pain in rats. Life Sci. 2018 May 1;200:69-80. doi: 10.1016/j.lfs.2018.03.028. Epub 2018 Mar 14.
Richardson JC, Ong BN, Sim J. Experiencing and controlling time in everyday life with chronic widespread pain: a qualitative study. BMC Musculoskelet Disord. 2008 Jan 11;9:3. doi: 10.1186/1471-2474-9-3.
Yamashita H, Tsukayama H, Tanno Y, Nishijo K. Adverse events in acupuncture and moxibustion treatment: a six-year survey at a national clinic in Japan. J Altern Complement Med. 1999 Jun;5(3):229-36. doi: 10.1089/acm.1999.5.229.
Other Identifiers
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8/19ης/22-11-2018
Identifier Type: -
Identifier Source: org_study_id
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