Clinical trial NCT04534179: Vacuum Myofascial Therapy Device and Physical Activity for the Treatment of Chronic Non-specific Low Back Pain. A Single Blind Randomized Clinical Trial
Official title: Vacuum Myofascial Therapy Device and Physical Activity for the Treatment of Chronic Non-specific Low Back Pain. A Single Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Nonspecific Low Back Pain
Keywords: negative pressure
vacuum
low back pain
physical therapy modalities
cupping
Lead sponsor: University of Cadiz
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A specialist physician will be diagnosed chronic nonspecific low back pain
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The intensity of pain: 10-point Numerical Pain Rating Scale
timeFrame: Baseline
Secondary outcomes:
measure: The intensity of pain: 10-point Numerical Pain Rating Scale
timeFrame: Immediately after the intervention , four and twelve weeks
measure: Active range of motion of the lumbar spine
timeFrame: Baseline , immediately after treatment, four and twelve weeks
measure: Pressure pain thresholds in trigger points
timeFrame: Baseline, immediately rafter treatment, four and twelve weeks
measure: Questionnaire SF 12
timeFrame: Baseline, immediately after treatment, four and twelve weeks
measure: OSWESTRY LOW BACK PAIN DISABILITY QUESTIONNAIRE
timeFrame: Baseline, immediately after treatment, four and twelve weeks
measure: Roland Morris Disability Questionnaire
timeFrame: Baseline, immediately after treatment, four and twelve weeks
Other outcomes:
Locations:
city: Cádiz
country: Spain
facility: Policlínica Santa María
Study officials:
affiliation: University of Cádiz
name: Manuel Manuel
role: PRINCIPAL_INVESTIGATOR
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