Vacuum Myofascial Therapy Device and Physical Activity for the Treatment of Chronic Non-specific Low Back Pain. A Single Blind Randomized Clinical Trial

Study Overview
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Brief Summary
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The term non-specific low back pain refers to the painful symptoms located in the lumbar region, which is delimited between the lower margin of the ribs and the lower limit of the buttocks

Detailed Description
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This study aimed to investigate the efficacy of a vacuum myofascial therapy device (VT) for improving pressure pain thresholds (PPTs), functionality, range of motion (ROM), low back pain-related disability, pain, and quality of life in patients with non-specific low back pain. Methods: A randomized controlled trial in which participants with non-specific low back pain (NP) were randomly assigned to either an experimental (VT) or a comparison physical therapy program (PTP) group.

Official Title
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Vacuum Myofascial Therapy Device and Physical Activity for the Treatment of Chronic Non-specific Low Back Pain. A Single Blind Randomized Clinical Trial

Conditions
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Chronic Nonspecific Low Back Pain

Intervention / Treatment
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* Procedure: Vacuum myofascial therapy and physical activity program.
* Other: Physical activity program.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed of Chronic Nonspecific Low Back Pain that do not improve with conventional physiotherapy or pharmacological therapy protocols. Subjects who are in an active state of pain Exclusion Criteria: Individuals who have received surgery intervention in the spine Individuals have received the proposed treatment in one month´s period previously. Individuals who suffering from fibromialgia síndrome, cardiac patients with pacemakers, cancer, infectious processes, or generalized lymphedema. Pregnant women can not receive this treatment intervention.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 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
Interventional Model Description: A specialist physician will be diagnosed chronic nonspecific low back pain
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vacuum myofascial therapy and physical activity<br>The protocol would last 5 weeks, group received fifteen 30-minute sessions of vacuum myofascial therapy and fifteen sessions physical activity program similar to the control group per week. | Procedure: Vacuum myofascial therapy and physical activity program.<br>* This group will treated five times with the analgesic program of physium therapy. Each maneuver was performed once per session by slow and progressive. The whole procedure lasted no more than 30 minutes. Then they carried out the physical activity program<br>|
| Active Comparator: Physical activity Program<br>The exercise protocol would last 5 weeks, performing 3 exercise sessions per week, with an effective work time of 30 minutes per session. The exercises would be directly focused on activating the core stabilizing muscles. | Other: Physical activity program.<br>* Active Comparator: Physical activity The exercise protocol would last 5 weeks, performing 3 exercise sessions per week, with an effective work time of 20 minutes per session. The exercises would be directly focused on activating the core stabilizing muscles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intensity of pain: 10-point Numerical Pain Rating Scale | A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area. The minimal clinically important difference (MCID) for the NPRS in patients with shoulder pain was 1.1 points (Mintken, Glynn, and Cleland 2009). | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intensity of pain: 10-point Numerical Pain Rating Scale | A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of lumbar pain, and the worst and lowest level of pain experienced in the preceding week in the lumbar area. | Immediately after the intervention , four and twelve weeks | 
| Active range of motion of the lumbar spine | Measured by a two branches goniometer | Baseline , immediately after treatment, four and twelve weeks | 
| Pressure pain thresholds in trigger points | Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline, Pain TestTM, Wagner Instruments). The clinimetric properties of this instrument have been evaluated previously. The PPT will the point at which pressure elicited pain and will presented as kilograms per square centimeter. All measurements will be conducted by the same well-trained physician. | Baseline, immediately rafter treatment, four and twelve weeks | 
| Questionnaire SF 12 | The multidimensional health related quality of life | Baseline, immediately after treatment, four and twelve weeks | 
| OSWESTRY LOW BACK PAIN DISABILITY QUESTIONNAIRE | The Oswestry Low Back Pain Disability Scale is a self-administered questionnaire, specific for low back pain, that measures limitations in daily activities. | Baseline, immediately after treatment, four and twelve weeks | 
| Roland Morris Disability Questionnaire | Roland Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities | Baseline, immediately after treatment, four and twelve weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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negative pressure, vacuum, low back pain, physical therapy modalities, cupping