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

Chronic Nonspecific Low Back Pain 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04534179
• Other study ID #: Physium and physical therapy
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: February 2022
• Source: University of Cadiz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 15, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Nonspecific Low Back Pain
• Low Back Pain

Intervention

Procedure:
• Vacuum 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

Other:
• Physical 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.

Locations

Country	Name	City	State
Spain	Policlínica Santa María	Cádiz

Sponsors (1)

Lead Sponsor	Collaborator
University of Cadiz

Country where clinical trial is conducted

Spain, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Active range of motion of the lumbar spine	Measured by a two branches goniometer	Baseline , immediately after treatment, four and twelve weeks
Secondary	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
Secondary	Questionnaire SF 12	The multidimensional health related quality of life	Baseline, immediately after treatment, four and twelve weeks
Secondary	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
Secondary	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