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NCT Number: NCT04534179

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

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

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Key information

Conditions

Chronic Nonspecific Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlínica Santa María

Cadiz, 11007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vacuum myofascial therapy and physical activity program.

Procedure

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

Physical activity program.

Other

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 outcomes

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

    Time frame: Baseline

    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 outcomes

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

    Time frame: Immediately after the intervention , four and twelve weeks

    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.

  2. Active range of motion of the lumbar spine

    Time frame: Baseline , immediately after treatment, four and twelve weeks

    Measured by a two branches goniometer

  3. Pressure pain thresholds in trigger points

    Time frame: Baseline, immediately rafter treatment, four and twelve weeks

    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.

  4. Questionnaire SF 12

    Time frame: Baseline, immediately after treatment, four and twelve weeks

    The multidimensional health related quality of life

  5. OSWESTRY LOW BACK PAIN DISABILITY QUESTIONNAIRE

    Time frame: Baseline, immediately after treatment, four and twelve weeks

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

  6. Roland Morris Disability Questionnaire

    Time frame: Baseline, immediately after treatment, four and twelve weeks

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

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 1, 2020
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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