Massage and Electroacupuncture in Chronic Lumbar Pain

NCT ID: NCT04108546

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2024-12-31

Brief Summary

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The aim of this study is to evaluate and compare in patients with chronic back pain two therapeutic interventions: a) the combination of massage and electroacupuncture; and b) the application of epidural analgesia in pain, functioning-incompetence, quality of life and mood.

Detailed Description

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Conditions

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Back Pain Lumbar Anesthesia, Local Epidural Electroacupuncture Massage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Group Type EXPERIMENTAL

Electroacupuncture device

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Epidural analgesia

Intervention Type DRUG

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.

Intervention Type DEVICE

Epidural analgesia

Epidural analgesia with lidocaine 2%, 1.5 ml, and Dexamethasone 8 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from lumbar pain of benign etiology
* Age 20 to 65 years

Exclusion Criteria

* Ages over 65 or below 20 years
* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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Elena Arnaoutoglou

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Larisa, Department of Anesthesiology

Larissa, Thessaly, Greece

Site Status

University Hospital of Larissa

Larissa, Thessaly, Greece

Site Status

Countries

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Greece

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.

Reference Type BACKGROUND
PMID: 12858464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16741943 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14660065 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29550358 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18190693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10381246 (View on PubMed)

Other Identifiers

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8/19ης/22-11-2018

Identifier Type: -

Identifier Source: org_study_id

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