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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

Primary Purpose

Chronic Nonspecific Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Vacuum myofascial therapy and physical activity program.

Physical activity program.

About this trial

This is an interventional treatment trial for Chronic Nonspecific Low Back Pain focused on measuring negative pressure, vacuum, low back pain, physical therapy modalities, cupping

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Policlínica Santa María

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vacuum myofascial therapy and physical activity

Physical activity Program

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Active range of motion of the lumbar spine

Measured by a two branches goniometer

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.

Questionnaire SF 12

The multidimensional health related quality of life

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.

Roland Morris Disability Questionnaire

Roland Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities

Full Information

NCT ID

NCT04534179

First Posted

August 17, 2020

Last Updated

February 16, 2022

Sponsor

University of Cadiz

1. Study Identification

Unique Protocol Identification Number

NCT04534179

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

December 15, 2020 (Actual)

Study Completion Date

January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cadiz

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Nonspecific Low Back Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A specialist physician will be diagnosed chronic nonspecific low back pain

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vacuum myofascial therapy and physical activity

Arm Type

Experimental

Arm 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.

Arm Title

Physical activity Program

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Vacuum myofascial therapy and physical activity program.

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Physical activity program.

Intervention Description

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.

Primary Outcome Measure Information:

Title

The intensity of pain: 10-point Numerical Pain Rating Scale

Description

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

The intensity of pain: 10-point Numerical Pain Rating Scale

Description

Time Frame

Immediately after the intervention , four and twelve weeks

Title

Active range of motion of the lumbar spine

Description

Measured by a two branches goniometer

Time Frame

Baseline , immediately after treatment, four and twelve weeks

Title

Pressure pain thresholds in trigger points

Description

Time Frame

Baseline, immediately rafter treatment, four and twelve weeks

Title

Questionnaire SF 12

Description

The multidimensional health related quality of life

Time Frame

Baseline, immediately after treatment, four and twelve weeks

Title

OSWESTRY LOW BACK PAIN DISABILITY QUESTIONNAIRE

Description

The Oswestry Low Back Pain Disability Scale is a self-administered questionnaire, specific for low back pain, that measures limitations in daily activities.

Time Frame

Baseline, immediately after treatment, four and twelve weeks

Title

Roland Morris Disability Questionnaire

Description

Roland Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities

Time Frame

Baseline, immediately after treatment, four and twelve weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manuel Manuel

Organizational Affiliation

University of Cádiz

Official's Role

Principal Investigator

Facility Information:

Facility Name

Policlínica Santa María

City

Cádiz

ZIP/Postal Code

11007

Country

Spain

12. IPD Sharing Statement

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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

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