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

NCT05202691 | Unknown

• 1 other identifier: ComplutenseHolystic
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Lumbar flexion Numerical Rating Scale

  4 weeks (immediately before and after each of the sessions)

• Lumbar extension Numerical Rating Scale

  4 weeks (immediately before and after each of the sessions)

• Finger to Floor test

  4 weeks (immediately before and after each of the sessions)

Study Arms (2)

Group 1 (Physical Therapy+Magnetic Field Therapy)

EXPERIMENTAL

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)

Group 2 (Physical Therapy)

ACTIVE COMPARATOR

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)

Interventions

Group 1 (Physical Therapy+Magnetic Field Therapy) 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)

Also known as: physical therapy and magnetic field therapy for low back pain

Group 1 (Physical Therapy+Magnetic Field Therapy)

Group 2 (Physical Therapy) OTHER

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

Also known as: physical therapy for low back pain

Group 2 (Physical Therapy)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Complutense University of Madrid

Madrid, Spain

Location

Related Publications (3)

• Markov MS. Magnetic field therapy: a review. Electromagn Biol Med. 2007;26(1):1-23. doi: 10.1080/15368370600925342.

  PMID: 17454079 BACKGROUND

• 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.

  PMID: 29356996 BACKGROUND

• 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.

  PMID: 33152929 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities; Magnetic Field Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Isidro Fernández-López, Dr.

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isidro Fernández-López, Dr.

CONTACT

+34625598970; isidrofelo@gmail.com

Pablo Llanes-Ontiveros, Mr.

CONTACT

+34629234854; pablo_llanes@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 21, 2022
• Study Start: March 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: March 1, 2023
• Last Updated: January 21, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)