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

University of Cadiz

Status: Completed

Conditions: Chronic Nonspecific Low Back Pain

Treatments: Procedure: Vacuum myofascial therapy and physical activity program.; Other: Physical activity program.

Study type: Interventional

Funder types: Other

Identifiers

NCT04534179

Physium and physical therapy

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Vacuum myofascial therapy and physical activity

Experimental group

Description:

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.

Treatment:

Procedure: Vacuum myofascial therapy and physical activity program.

Physical activity Program

Active Comparator group

Description:

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.

Treatment:

Other: Physical activity program.