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Clinical Trials/NCT05202691
NCT05202691
Unknown
Not Applicable

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

Universidad Complutense de Madrid1 site in 1 country40 target enrollmentMarch 2022
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Universidad Complutense de Madrid
Enrollment
40
Locations
1
Primary Endpoint
Lumbar pain change with the Pain Detect Questionnaire
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2022
End Date
March 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

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.

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 Outcomes

  • 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 Sites (1)

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