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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Group 1 (Physical Therapy+Magnetic Field Therapy); Other: Group 2 (Physical Therapy)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isidro Fernández-López, Dr.; Phone Number: +34625598970; Email: isidrofelo@gmail.com
• Study Contact Backup: Name: Pablo Llanes-Ontiveros, Mr.; Phone Number: +34629234854; Email: pablo_llanes@hotmail.com

Study Locations

• Spain
  • Madrid, Spain
    • Complutense University of Madrid
    • Contact: Isidro Fernández-López, Dr.; Phone Number: +34625598970; Email: isidrofelo@gmail.com
    • Principal Investigator: Isidro Fernández-López, Dr.
    • Sub-Investigator: Pablo Llanes-Ontiveros, Mr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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); Other Names: physical therapy and magnetic field therapy for low back pain
Active Comparator: 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.	Other: Group 2 (Physical Therapy); A Physical Therapy Protocol (including manual therapy, stretching and exercise for low back pain); Other Names: physical therapy for low back pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lumbar pain change with the Pain Detect Questionnaire	lumbar pain at this moment and in the last 4 weeks evaluated with the Pain Detect Questionnaire. The Questionnaire has a maximum score of 35 and a minimum score of 0. Lower scores mean a better outcome.	Change from Baseline Lumbar pain at 4 weeks.
Disability Questionnaire 1 change	Disability Questionnaire assessed with the Roland-Morris Questionnaire. The Questionnaire has a maximum score of 24 and a minimum score of 0. Lower scores mean a better outcome.	Change from Baseline degree of diability at 4 weeks.
Disability Questionnaire 2 change	Disability Questionnaire 2 assessed with the Oswestry Disability Index. The Oswestry Disability Index is scored from 0 (absence of disability) to 100 (maximum disability). This questionnaire has 10 multiple-choice questions, each of which may be scored between 0 (no disability) and 5 (maximum disability). Lower scores mean a better outcome.	Change from Baseline degree of diability at 4 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lumbar flexion Numerical Rating Scale	Lumbar flexion evaluated with a Numerical Rating Scale. The minimum value is 0 and the maximum value is 10. Lower scores mean a better outcome.	4 weeks (immediately before and after each of the sessions)
Lumbar extension Numerical Rating Scale	Lumbar extension evaluated with a Numerical Rating Scale. The minimum value is 0 and the maximum value is 10. Lower scores mean a better outcome.	4 weeks (immediately before and after each of the sessions)
Finger to Floor test	Lumbar mobility evaluated with the finger-to-floor test, assessed before and after each session in all the participants. The minimum value is 0 centimeters and the maximum value depending the flexibility os each participant and the distance, in centimeters between fingers anthe floor. Lower distance in centimeters means a better outcome.	4 weeks (immediately before and after each of the sessions)

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Principal Investigator: Isidro Fernández-López, Dr., Complutense University of Madrid

Publications and helpful links

General Publications

• Markov MS. Magnetic field therapy: a review. Electromagn Biol Med. 2007;26(1):1-23. doi: 10.1080/15368370600925342.
• Daish C, Blanchard R, Fox K, Pivonka P, Pirogova E. The Application of Pulsed Electromagnetic Fields (PEMFs) for Bone Fracture Repair: Past and Perspective Findings. Ann Biomed Eng. 2018 Apr;46(4):525-542. doi: 10.1007/s10439-018-1982-1. Epub 2018 Jan 22.
• Hu H, Yang W, Zeng Q, Chen W, Zhu Y, Liu W, Wang S, Wang B, Shao Z, Zhang Y. Promising application of Pulsed Electromagnetic Fields (PEMFs) in musculoskeletal disorders. Biomed Pharmacother. 2020 Nov;131:110767. doi: 10.1016/j.biopha.2020.110767. Epub 2020 Sep 23.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: rehabilitation; low back pain; physical therapy; magnetic field therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: ComplutenseHolystic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No