Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04534179
Enrollment
50
Registered
2020-09-01
Start date
2020-09-01
Completion date
2021-01-15
Last updated
2022-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Nonspecific Low Back Pain

Keywords

negative pressure, vacuum, low back pain, physical therapy modalities, cupping

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.

Interventions

PROCEDUREVacuum myofascial therapy and physical activity program.

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

OTHERPhysical activity program.

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.

Sponsors

University of Cadiz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

A specialist physician will be diagnosed chronic nonspecific low back pain

Eligibility

Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The intensity of pain: 10-point Numerical Pain Rating ScaleBaselineA 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).

Secondary

MeasureTime frameDescription
Active range of motion of the lumbar spineBaseline , immediately after treatment, four and twelve weeksMeasured by a two branches goniometer
Pressure pain thresholds in trigger pointsBaseline, immediately rafter treatment, four and twelve weeksPressure 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.
The intensity of pain: 10-point Numerical Pain Rating ScaleImmediately after the intervention , four and twelve weeksA 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.
OSWESTRY LOW BACK PAIN DISABILITY QUESTIONNAIREBaseline, immediately after treatment, four and twelve weeksThe Oswestry Low Back Pain Disability Scale is a self-administered questionnaire, specific for low back pain, that measures limitations in daily activities.
Roland Morris Disability QuestionnaireBaseline, immediately after treatment, four and twelve weeksRoland Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities
Questionnaire SF 12Baseline, immediately after treatment, four and twelve weeksThe multidimensional health related quality of life

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026