Massage and Electroacupuncture in Chronic Lumbar Pain

Not Applicable

Completed

• Conditions: Back Pain; Anesthesia, Local; Epidural; Electroacupuncture; Massage; Lumbar
• Interventions: Device: Electroacupuncture device; Drug: Epidural analgesia

• Registration Number: NCT04108546
• Lead Sponsor: University of Thessaly

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-09-30
• Study Start: 2020-02-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
massage-electroacupuncture	Electroacupuncture device	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	Epidural analgesia	Epidural analgesia will be applied using lidocaine 2%, 1.5 ml, and Dexamethasone 8 mg

Primary Outcome Measures

Name	Time	Method
Assessment of pain intensity: NRS	2 years	The Numeric Rating Scale 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	2 years	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	2 years	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	2 years	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).

Trial Locations

Locations (2)

University Hospital of Larisa, Department of Anesthesiology; 🇬🇷 Larisa, Thessaly, Greece

University Hospital of Larissa; 🇬🇷 Larissa, Thessaly, Greece