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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
110
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 with lidocaine 2%, 1.5 ml, and Dexamethasone 8 mg
University Hospital of Larisa, Department of Anesthesiology
Larissa, Thessaly, Greece
University Hospital of Larissa
Larissa, Thessaly, Greece
Assessment of pain intensity: NRS
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).
Time frame: 2 years
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
Time frame: 2 years
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.
Time frame: 2 years
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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 2 years