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

Universidad Complutense de Madrid

Status: Unknown

Conditions: Low Back Pain

Treatments: Other: Group 2 (Physical Therapy); Other: Group 1 (Physical Therapy+Magnetic Field Therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT05202691

ComplutenseHolystic

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The inclusion criteria were individuals aged between 18 and 65 years with a diagnosis of non-specific low back pain, with or without lower limb irradiation, lasting at least 6 weeks.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Group 1 (Physical Therapy+Magnetic Field Therapy)

Experimental group

Description:

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.

Treatment:

Other: Group 1 (Physical Therapy+Magnetic Field Therapy)

Group 2 (Physical Therapy)

Active Comparator group

Description:

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.

Treatment:

Other: Group 2 (Physical Therapy)