Comparison of the Effects of Physical Therapy With and Without Magnetic Field Therapy in People With Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2023-03-31

Brief Summary

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A randomized and controlled trial to people with low back pain who are divided into 2 groups of treatment: 1- people treated with a protocol of physical therapy techniques without magnetic field therapy; 2- people treated with the same protocol of physical therapy techniques adding a magnetic stimulation treatment. The interventions are conducted in 3 sessions provided during 3 weeks.The lumbar pain and disability are assessed before and after the intervention, and lumbar flexion and extension pain are assessed before and after each session in all the participants.

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Detailed Description

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This study is a randomized controlled trial evaluating clinical effects of a protocol of Physical Therapy Treatment (PTT), via manual therapy and active mobilization, adding or not a magnetic field therapy in people with non-specific low back pain lasting at least 6 weeks. Participants were randomized to receive either a PTT protocol including a magnetic stimulation treatment or the same PTT protocol with a sham magnetic intervention. The interventions are conducted in 3 sessions provided during 3 weeks.

Intervention:

A description of the 2 groups of treatment:

1. \- Experimental group 1: a protocol of physical therapy treatment including:

* Manual therapy techniques for inhibition of piriformis, quadratus lumbar, and paravertebral muscles in prone position and bilaterally.
* 2 functional techniques applied to the sacrum in prone position.
* A myofascial release of ligaments inserted to the sacrum in prone position and bilaterally.
* Manual therapy technique for inhibition of psoas-iliacus muscle in supine position and bilaterally.
* Stretching techniques of piriformis, gluteal and paravertebral muscles in supine position and bilaterally.
* Active gluteus maximus contraction in supine position bilaterally.

To this protocol, a 15 minutes of magnetic field therapy treatment applied to the lumbosacral region in prone position is added.
2. \- Experimental group 2: the same Physical Therapy Treatment protocol with a sham magnetic intervention applying in the same region with a disconnected device during 15 minutes.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a randomized controlled trial evaluating clinical effects in people with low back pain who are divided into 2 groups of treatment, where the interventions are conducted in 3 sessions provided during 3 weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

To participants: the intervention applied to both groups is the same Physical Therapy Treatment protocol and the use of the same magnetic field therapy device during the same time (for the sham group: the device is disconnected and the sound is simulated with a recording).

The investigator assessing the outcomes is blinded to the group assignments

Study Groups

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Group 1 (Physical Therapy+Magnetic Field Therapy)

Physical Therapy Protocol plus Magnetic Field Therapy

A protocol of physical therapy treatment including:

* Manual therapy techniques for inhibition of piriformis, quadratus lumbaris, and paravertebral muscles in prone position and bilaterally.
* 2 functional techniques applied to the sacrum in prone position.
* A myofascial release of ligaments inserted to the sacrum in prone position and bilaterally.
* Manual therapy technique for inhibition of psoas-iliacus muscle in supine position and bilaterally.
* Stretching techniques of piriformis, gluteal and paravertebral muscles in supine position and bilaterally.
* Active gluteus maximus contraction in supine position bilaterally.

To this protocol, a 15 minutes of Magnetic Field Therapy using the Zimmer EmfieldPro device (Zimmer MedizinSysteme, Germany) applied to the lumbosacral region in prone position is added.

Group Type EXPERIMENTAL

Group 1 (Physical Therapy+Magnetic Field Therapy)

Intervention Type OTHER

A Physical Therapy Protocol (including manual therapy, stretching and exercise for low back pain) adding a Magnetic Field Therapy using the Zimmer EmfieldPro device (Zimmer MedizinSysteme, Germany)

Group 2 (Physical Therapy)

Physical Therapy Protocol alone:

The same Physical Therapy Treatment protocol with a sham magnetic intervention applying in the same region with a disconnected Zimmer EmfieldPro device (Zimmer MedizinSysteme, Germany) during 15 minutes.

Group Type ACTIVE_COMPARATOR

Group 2 (Physical Therapy)

Intervention Type OTHER

A Physical Therapy Protocol (including manual therapy, stretching and exercise for low back pain)

Interventions

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Group 1 (Physical Therapy+Magnetic Field Therapy)

A Physical Therapy Protocol (including manual therapy, stretching and exercise for low back pain) adding a Magnetic Field Therapy using the Zimmer EmfieldPro device (Zimmer MedizinSysteme, Germany)

Intervention Type OTHER

Group 2 (Physical Therapy)

A Physical Therapy Protocol (including manual therapy, stretching and exercise for low back pain)

Intervention Type OTHER

Other Intervention Names

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physical therapy and magnetic field therapy for low back pain physical therapy for low back pain

Eligibility Criteria

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Exclusion Criteria

* Pregnancy, spinal tumor or infection, diabetes, spinal fracture or previous spine surgery.
* Patients with a history of rehabilitation treatment for back pain within the preceding month
* Unstable medical disorder not controlled by standard treatment and those with a cardiac pacemaker or using any other electrical devices or prosthesis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No