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Completed

NCT Number: NCT04108546

Massage and Electroacupuncture in Chronic Lumbar Pain

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.

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Key information

Conditions

Back Pain Anesthesia, Local Electroacupuncture Epidural Lumbar Massage Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Larisa, Department of Anesthesiology, Larissa, Thessaly, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electroacupuncture device

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

Drug

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

Primary outcomes

  1. Assessment of pain intensity: NRS

    Time frame: 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).

  2. Assessment of functional status and incompetence in both groups

    Time frame: 2 years

    The Oswestry & Roland-Morris Disability Questionnaire (specific for low-back pain) will be used to assess patient functional status and incompetence

  3. Measurement of health-related quality of life

    Time frame: 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.

  4. Profile of mood states

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

The Effect of Combination of Massage and Electroacupuncture in Patients with Chronic Lumbar Pain. Comparison with the Use of Epidural Analgesia

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 30, 2019
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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