Clinical trial NCT05202691: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
physical therapy
rehabilitation
magnetic field therapy
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: Lumbar pain change with the Pain Detect Questionnaire
timeFrame: Change from Baseline Lumbar pain at 4 weeks.
measure: Disability Questionnaire 1 change
timeFrame: Change from Baseline degree of diability at 4 weeks.
measure: Disability Questionnaire 2 change
timeFrame: Change from Baseline degree of diability at 4 weeks.
Secondary outcomes:
measure: Lumbar flexion Numerical Rating Scale
timeFrame: 4 weeks (immediately before and after each of the sessions)
measure: Lumbar extension Numerical Rating Scale
timeFrame: 4 weeks (immediately before and after each of the sessions)
measure: Finger to Floor test
timeFrame: 4 weeks (immediately before and after each of the sessions)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Complutense University of Madrid
Study officials:
affiliation: Universidad Complutense de Madrid
name: Isidro Fernández-López, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Markov MS. Magnetic field therapy: a review. Electromagn Biol Med. 2007;26(1):1-23. doi: 10.1080/15368370600925342.
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.
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.