Massage and Electroacupuncture in Chronic Lumbar Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Massage, Electroacupuncture, Back Pain, Lumbar, Anesthesia, Local, Epidural

Intervention / Treatment
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* Device: Electroacupuncture device
* Drug: Epidural analgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: massage-electroacupuncture<br>Electroacupuncture will be applied throughout the back of the body, upper limbs and ears.Massage will follow the same paths of acupuncture points respectively | Device: Electroacupuncture device<br>* 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.<br>|
| Active Comparator: Epidural analgesia<br>Epidural analgesia will be applied using ropivacaine 0.2%, 5-7% ml and Fentanyl 25 mcg | Drug: Epidural analgesia<br>* Ropivacaine (Naropeine) 0.2%, 5-7% ml, and Fentanyl 25mcg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 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. | 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). | 2 years |