Clinical trial NCT04108546: Massage and Electroacupuncture in Chronic Lumbar Pain
Official title: The Effect of Combination of Massage and Electroacupuncture in Patients with Chronic Lumbar Pain. Comparison with the Use of Epidural Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Lumbar
Anesthesia, Local
Epidural
Electroacupuncture
Massage
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of pain intensity: NRS
timeFrame: 2 years
measure: Assessment of functional status and incompetence in both groups
timeFrame: 2 years
measure: Measurement of health-related quality of life
timeFrame: 2 years
measure: Profile of mood states
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Larisa
country: Greece
facility: University Hospital of Larisa, Department of Anesthesiology
state: Thessaly
city: Larissa
country: Greece
facility: University Hospital of Larissa
state: Thessaly
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.