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

Primary Purpose

Low Back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Group 1 (Physical Therapy+Magnetic Field Therapy)
Group 2 (Physical Therapy)
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, physical therapy, rehabilitation, magnetic field therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Complutense University of Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1 (Physical Therapy+Magnetic Field Therapy)

Group 2 (Physical Therapy)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
December 9, 2021
Last Updated
January 17, 2022
Sponsor
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT05202691
Brief Title
Comparison of the Effects of Physical Therapy With and Without Magnetic Field Therapy in People With Low Back Pain
Official Title
Comparison of the Effects of Physical Therapy With and Without Magnetic Field Therapy in People With Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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: - 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. - 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, physical therapy, rehabilitation, magnetic field therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Physical Therapy+Magnetic Field Therapy)
Arm Type
Experimental
Arm 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.
Arm Title
Group 2 (Physical Therapy)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Group 1 (Physical Therapy+Magnetic Field Therapy)
Other Intervention Name(s)
physical therapy and magnetic field therapy for low back pain
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Group 2 (Physical Therapy)
Other Intervention Name(s)
physical therapy for low back pain
Intervention Description
A Physical Therapy Protocol (including manual therapy, stretching and exercise for low back pain)
Primary Outcome Measure Information:
Title
Lumbar pain change with the Pain Detect Questionnaire
Description
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.
Time Frame
Change from Baseline Lumbar pain at 4 weeks.
Title
Disability Questionnaire 1 change
Description
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.
Time Frame
Change from Baseline degree of diability at 4 weeks.
Title
Disability Questionnaire 2 change
Description
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.
Time Frame
Change from Baseline degree of diability at 4 weeks.
Secondary Outcome Measure Information:
Title
Lumbar flexion Numerical Rating Scale
Description
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.
Time Frame
4 weeks (immediately before and after each of the sessions)
Title
Lumbar extension Numerical Rating Scale
Description
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.
Time Frame
4 weeks (immediately before and after each of the sessions)
Title
Finger to Floor test
Description
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.
Time Frame
4 weeks (immediately before and after each of the sessions)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isidro Fernández-López, Dr.
Phone
+34625598970
Email
isidrofelo@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pablo Llanes-Ontiveros, Mr.
Phone
+34629234854
Email
pablo_llanes@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isidro Fernández-López, Dr.
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complutense University of Madrid
City
Madrid
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isidro Fernández-López, Dr.
Phone
+34625598970
Email
isidrofelo@gmail.com
First Name & Middle Initial & Last Name & Degree
Isidro Fernández-López, Dr.
First Name & Middle Initial & Last Name & Degree
Pablo Llanes-Ontiveros, Mr.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17454079
Citation
Markov MS. Magnetic field therapy: a review. Electromagn Biol Med. 2007;26(1):1-23. doi: 10.1080/15368370600925342.
Results Reference
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PubMed Identifier
29356996
Citation
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.
Results Reference
background
PubMed Identifier
33152929
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.
Results Reference
background

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

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