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Massage and Electroacupuncture in Chronic Lumbar Pain

Primary Purpose

Back Pain, Lumbar, Anesthesia, Local

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Electroacupuncture device
Epidural analgesia
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Larisa, Department of AnesthesiologyRecruiting
  • University Hospital of Larissa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

massage-electroacupuncture

Epidural analgesia

Arm Description

Electroacupuncture will be applied throughout the back of the body, upper limbs and ears.Massage will follow the same paths of acupuncture points respectively

Epidural analgesia will be applied using ropivacaine 0.2%, 5-7% ml and Fentanyl 25 mcg

Outcomes

Primary Outcome Measures

Assessment of pain intensity: VAS
The Visual Analog Scale scale in its numerical version will be used to evaluate the pain. The Numeric Pain Rating Scale is a segmented numeric version of the Visual Analog Scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain (0 - no pain, 10 - worst pain).
Assessment of functional status and incompetence in both groups
The Oswestry & Roland-Morris Disability Questionnaire (specific for low-back pain) will be used to assess patient functional status and incompetence
Measurement of health-related quality of life
The SF-36 Health Survey questionnaire will be used. It is a generic measure of health status as opposed to one that targets a specific age, disease, or treatment group. It has three levels: (1) items; (2) eight scales that aggregate 2-10 items each; and (3) two summary measures that aggregate scales. Each item is used in scoring only one scale. Three scales (Physical Functioning, Role-Physical, Bodily Pain) correlate most highly with the physical component and contribute most to the scoring of the Physical Component Summary measure. The mental component correlates most highly with the Mental Health, Role-Emotional, and Social Functioning scales, which also contribute most to the scoring of the Mental Component Summary measure. Three of the scales (Vitality, General Health, and Social Functioning) have noteworthy correlations with both components. The SF-36 has a verbatim content and response choices.
Profile of mood states
The The Profile of Mood States (acronym: POMS) is a standard validated psychological test. This questionnaire will be used to investigate the mood level. It is a questionnaire investigating the mood level and assessing the impact of a program on the patient mood in the short term. The questionnaire consists of 72 adjectives related to mood, which are grouped into 6 factors. The first five factors are negatively rated (high scores correspond to more negative emotions). The sixth factor is scored positively (high scores correspond to higher vitality). Participants are asked to complete these adjectives in a 5-point Likert-type scale ranging from "not at all" (0) to "extremely" (4).

Secondary Outcome Measures

Full Information

First Posted
May 9, 2019
Last Updated
November 9, 2021
Sponsor
University of Thessaly
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1. Study Identification

Unique Protocol Identification Number
NCT04108546
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Lumbar, Anesthesia, Local, Epidural, Electroacupuncture, Massage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
massage-electroacupuncture
Arm Type
Experimental
Arm Description
Electroacupuncture will be applied throughout the back of the body, upper limbs and ears.Massage will follow the same paths of acupuncture points respectively
Arm Title
Epidural analgesia
Arm Type
Active Comparator
Arm Description
Epidural analgesia will be applied using ropivacaine 0.2%, 5-7% ml and Fentanyl 25 mcg
Intervention Type
Device
Intervention Name(s)
Electroacupuncture device
Intervention Description
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
Drug
Intervention Name(s)
Epidural analgesia
Intervention Description
Ropivacaine (Naropeine) 0.2%, 5-7% ml, and Fentanyl 25mcg
Primary Outcome Measure Information:
Title
Assessment of pain intensity: VAS
Description
The Visual Analog Scale scale in its numerical version will be used to evaluate the pain. The Numeric Pain Rating Scale is a segmented numeric version of the Visual Analog Scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain (0 - no pain, 10 - worst pain).
Time Frame
2 years
Title
Assessment of functional status and incompetence in both groups
Description
The Oswestry & Roland-Morris Disability Questionnaire (specific for low-back pain) will be used to assess patient functional status and incompetence
Time Frame
2 years
Title
Measurement of health-related quality of life
Description
The SF-36 Health Survey questionnaire will be used. It is a generic measure of health status as opposed to one that targets a specific age, disease, or treatment group. It has three levels: (1) items; (2) eight scales that aggregate 2-10 items each; and (3) two summary measures that aggregate scales. Each item is used in scoring only one scale. Three scales (Physical Functioning, Role-Physical, Bodily Pain) correlate most highly with the physical component and contribute most to the scoring of the Physical Component Summary measure. The mental component correlates most highly with the Mental Health, Role-Emotional, and Social Functioning scales, which also contribute most to the scoring of the Mental Component Summary measure. Three of the scales (Vitality, General Health, and Social Functioning) have noteworthy correlations with both components. The SF-36 has a verbatim content and response choices.
Time Frame
2 years
Title
Profile of mood states
Description
The The Profile of Mood States (acronym: POMS) is a standard validated psychological test. This questionnaire will be used to investigate the mood level. It is a questionnaire investigating the mood level and assessing the impact of a program on the patient mood in the short term. The questionnaire consists of 72 adjectives related to mood, which are grouped into 6 factors. The first five factors are negatively rated (high scores correspond to more negative emotions). The sixth factor is scored positively (high scores correspond to higher vitality). Participants are asked to complete these adjectives in a 5-point Likert-type scale ranging from "not at all" (0) to "extremely" (4).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Hospital of Larisa, Department of Anesthesiology
City
Larisa
State/Province
Thessaly
ZIP/Postal Code
41110
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleni Arnaoutoglou, Prof.
Phone
+302413502953
Email
earnaout@gmail.com
First Name & Middle Initial & Last Name & Degree
Barbara Boutsis
Phone
+302413502953
Email
barbiebou@yahoo.com
Facility Name
University Hospital of Larissa
City
Larissa
State/Province
Thessaly
ZIP/Postal Code
41110
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleni Arnaoutoglou, M.D. Ph.D.
Phone
6975301352
Email
earnaout@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
12858464
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
14660065
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.
Results Reference
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PubMed Identifier
29550358
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
10381246
Citation
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Results Reference
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Massage and Electroacupuncture in Chronic Lumbar Pain

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