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

NCT04534179 | Completed DMC

• 1 other identifier: Physium and physical therapy
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Nonspecific Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  Immediately after the intervention , four and twelve weeks

• Active range of motion of the lumbar spine

  Baseline , immediately after treatment, four and twelve weeks

• Pressure pain thresholds in trigger points

  Baseline, immediately rafter treatment, four and twelve weeks

• Questionnaire SF 12

  Baseline, immediately after treatment, four and twelve weeks

• OSWESTRY LOW BACK PAIN DISABILITY QUESTIONNAIRE

  Baseline, immediately after treatment, four and twelve weeks

Study Arms (2)

Vacuum myofascial therapy and physical activity

EXPERIMENTAL

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.

Procedure: Vacuum myofascial therapy and physical activity program.

Physical activity Program

ACTIVE COMPARATOR

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.

Other: Physical activity program.

Interventions

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

Vacuum myofascial therapy and physical activity

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.

Physical activity Program

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cadiz: lead

Study Sites (1)

Policlínica Santa María

Cadiz, 11007, Spain

Location

Related Publications (28)

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MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel Manuel

  University of Cádiz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: A specialist physician will be diagnosed chronic nonspecific low back pain

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: September 1, 2020
• Study Start: September 1, 2020
• Primary Completion: December 15, 2020
• Study Completion: January 15, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-02

Locations

ES (1)