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

• ClinicalTrials.gov Identifier: NCT05202691
• Recruitment Status: Not yet recruiting
• First Posted: January 21, 2022
• Last Update Posted: January 21, 2022
• Sponsor: Universidad Complutense de Madrid
• Information provided by (Responsible Party): Universidad Complutense de Madrid

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Other: Group 1 (Physical Therapy+Magnetic Field Therapy); Other: Group 2 (Physical Therapy)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

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

• Primary Purpose: Treatment
• Official Title: Comparison of the Effects of Physical Therapy With and Without Magnetic Field Therapy in People With Low Back Pain
• Estimated Study Start Date: March 2022
• Estimated Primary Completion Date: May 2022
• Estimated Study Completion Date: March 2023

Arms and Interventions

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 Name: 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 Name: physical therapy for low back pain

Outcome Measures

Primary Outcome Measures :

1. Lumbar pain change with the Pain Detect Questionnaire [ Time Frame: Change from Baseline Lumbar pain at 4 weeks. ]
   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.
2. Disability Questionnaire 1 change [ Time Frame: Change from Baseline degree of diability at 4 weeks. ]
   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.
3. Disability Questionnaire 2 change [ Time Frame: Change from Baseline degree of diability at 4 weeks. ]
   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.

Secondary Outcome Measures :

1. Lumbar flexion Numerical Rating Scale [ Time Frame: 4 weeks (immediately before and after each of the sessions) ]
   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.
2. Lumbar extension Numerical Rating Scale [ Time Frame: 4 weeks (immediately before and after each of the sessions) ]
   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.
3. Finger to Floor test [ Time Frame: 4 weeks (immediately before and after each of the sessions) ]
   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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Isidro Fernández-López, Dr.; +34625598970; isidrofelo@gmail.com

Contact: Pablo Llanes-Ontiveros, Mr.; +34629234854; pablo_llanes@hotmail.com

Locations

Spain

Complutense University of Madrid

Madrid, Spain

Contact: Isidro Fernández-López, Dr. +34625598970 isidrofelo@gmail.com

Principal Investigator: Isidro Fernández-López, Dr.

Sub-Investigator: Pablo Llanes-Ontiveros, Mr.

Sponsors and Collaborators

Universidad Complutense de Madrid

Investigators

• Principal Investigator: Isidro Fernández-López, Dr.; Complutense University of Madrid

More Information

Publications:

Markov MS. Magnetic field therapy: a review. Electromagn Biol Med. 2007;26(1):1-23. Review.

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. Review.

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. Review.

• Responsible Party: Universidad Complutense de Madrid
• ClinicalTrials.gov Identifier: NCT05202691
• Other Study ID Numbers: ComplutenseHolystic
• First Posted: January 21, 2022
• Last Update Posted: January 21, 2022
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universidad Complutense de Madrid:

low back pain; physical therapy; rehabilitation; magnetic field therapy

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations