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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05202691
• Other study ID #: ComplutenseHolystic
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: March 2023

Study information

• Verified date: December 2021
• Source: Universidad Complutense de Madrid
• Contact: Isidro Fernández-López, Dr.
• Phone: +34625598970
• Email: isidrofelo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2023
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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)
• Group 2 (Physical Therapy)
A Physical Therapy Protocol (including manual therapy, stretching and exercise for low back pain)

Locations

Country	Name	City	State
Spain	Complutense University of Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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)
Secondary	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)
Secondary	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)