search
Back to results

Comparison of Two Electrotherapy Methods on Chronic Low Back Pain

Primary Purpose

Low Back Pain, Mechanical

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pulse Electromagnetic Field
Interferential Current
Sham
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Mechanical focused on measuring Rehabilitation, Electric Stimulation Therapy, Quality of Life, Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being diagnosed with nonspecific low back pain
  • Symptom onset with more than 3 months

Exclusion Criteria:

  • History of surgery on low back region
  • Structural deformity on the low back region
  • Radiculopathy
  • Tumor or malignancy
  • Any skin condition that prevents usage of electrotherapy
  • Having a pace maker or other types of implants on the low back, pelvis and thoracic region

Sites / Locations

  • Faculty of Health Sciences Bolu Abant Izzet Baysal University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Pulse Electromagnetic Field Group

Interferential Current Group

Sham Group

Arm Description

Pulse Electromagnetic Field Therapy (PEMF) will be applied to patients' low back region. Also, patients will receive a conventional therapy program consisting of hotpack, ultrasound, and transcutaneous electrical stimulation in addition to PEMF therapy.

Interferential current will be applied to patients' low back pain region. Also, patients will receive a conventional therapy program consisting of hotpack, ultrasound, and transcutaneous electrical stimulation in addition to Interferential current.

Sham electrodes will be placed on the low back region. Also, patients will receive a conventional therapy program consisting of hotpack, ultrasound, and transcutaneous electrical stimulation in addition to sham therapy.

Outcomes

Primary Outcome Measures

The Numerical Rating Scale (NRS)
It contains 11 digits that should be assigned according to the perceived pain intensity on a numerical scale. The participant chooses the number that best reflects his or her pain. In our study, the patients were informed that the '0' point was not pain at all, and the '10' point expressed unbearable pain.

Secondary Outcome Measures

Roland-Morris Disability Questionnaire
It is a questionnaire developed to evaluate functional disabilities in patients with low back pain. Turkish validity and reliability study was conducted in 2001 (20). In the 24-sentence questionnaire about functional impairments, patients are asked to answer each sentence as yes if it fits their situation, and no if it does not. Yes responses are calculated as "1" and no answers are calculated as "0" points. In this questionnaire with a total score between 0-24, the higher score means more disability.
Euroqol Quality Of Life Scale
EQ-5D is a self-report scale developed by the EuroQoL group, the Western European quality of life research community, and evaluates five dimensions with 1 question each. These five dimensions consist of subtitles of mobility, self-care, usual daily activities, pain / discomfort and anxiety / depression. The answers given to each dimension have 3 options: no problem, some problem and major problem. As a result, 243 possible different health outcomes are defined with the scale. An index score ranging from -0.59 to 1 is calculated from the 5 dimensions of the scale. In the score function, a value of 0 indicates death, a value of 1 indicates perfect health, while negative values indicate unconsciousness, living dependent on bed, etc. show situations. Also included in the scale is a VAS (EQ-VAS) that includes answers between 0 and 100, ie "0 = the worst health condition imaginable" and "100 = the best health condition imaginable".

Full Information

First Posted
April 22, 2021
Last Updated
September 22, 2023
Sponsor
Abant Izzet Baysal University
search

1. Study Identification

Unique Protocol Identification Number
NCT04859842
Brief Title
Comparison of Two Electrotherapy Methods on Chronic Low Back Pain
Official Title
Comparison of Effectiveness of Pulsed Electromagnetic Field Therapy and Interferential Current on Patients With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
December 21, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

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
The purpose of this study is; to compare the effects of interferential current therapy (IF) applied in addition to conventional physical therapy on pain, functional status and quality of life compared to pulsed electromagnetic field therapy (PEMF) in patients with chronic low back pain.
Detailed Description
The low back is the most common region for musculoskeletal pain. Many factors play a role in the etiology of low back pain. A certain etiological factor or pathophysiological mechanism cannot be found in 85-90% of the patients. Approximately 80% of those living in industrialized countries experience low back pain in some part of their lives. 10% of low back pain becomes chronic. It is believed that 1% of workforce losses are due to low back pain. This type of pain often occurs when the back muscles, tendons and ligaments are exposed to stress or strain. Mechanical back pains are chronic pain that often affects the lower part of the spine and radiates to the gluteal region. Since daily activities such as leaning, turning, lifting, standing and sitting for a long time increase the pain, the intensity of the pain increases during the day. Interferential current (IF) therapy is obtained from two medium frequency currents and is applied by delivering a low frequency current (for example 20 to 100 Hz) to the tissue. Pulsed ElectroMagnetic Field (PEMF) therapy, which is among physical therapy methods, is frequently used in the treatment of knee, hip and spine osteoarthritis symptoms. It is thought that magnetic field therapy improves the oxygen utilization of the cells and the erythrocytes release more oxygen under the influence of the magnetic field, thus having a positive effect on the circulatory system

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical
Keywords
Rehabilitation, Electric Stimulation Therapy, Quality of Life, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three groups with a conventional therapy control group.
Masking
ParticipantOutcomes Assessor
Masking Description
Conventional therapy group will receive sham electrotherapy sessions and outcome assessments will be performed by a investigator who was blinded to group allocation.
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulse Electromagnetic Field Group
Arm Type
Active Comparator
Arm Description
Pulse Electromagnetic Field Therapy (PEMF) will be applied to patients' low back region. Also, patients will receive a conventional therapy program consisting of hotpack, ultrasound, and transcutaneous electrical stimulation in addition to PEMF therapy.
Arm Title
Interferential Current Group
Arm Type
Active Comparator
Arm Description
Interferential current will be applied to patients' low back pain region. Also, patients will receive a conventional therapy program consisting of hotpack, ultrasound, and transcutaneous electrical stimulation in addition to Interferential current.
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
Sham electrodes will be placed on the low back region. Also, patients will receive a conventional therapy program consisting of hotpack, ultrasound, and transcutaneous electrical stimulation in addition to sham therapy.
Intervention Type
Other
Intervention Name(s)
Pulse Electromagnetic Field
Intervention Description
Patients will be treated for two weeks, five days a week, one session a day, and 10 sessions with PEMF in prone position. Each session will be 45 minute long with a 15 minute PEMF therapy and a 30 minute conventional therapy program.
Intervention Type
Other
Intervention Name(s)
Interferential Current
Intervention Description
Patients will be treated for two weeks, five days a week, one session a day, and 10 sessions with Interferential current in prone position. Four interferential electrode will be placed on low back region. Each session will be 45 minute long with a 15 minute interferential current and a 30 minute conventional therapy program.
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Patients will be treated for two weeks, five days a week, one session a day, and 10 sessions with conventional therapy and sham electrotherapy. Sham application will be performed on prone position with four electrodes and electrodes will stay for 15 minutes on this region.
Primary Outcome Measure Information:
Title
The Numerical Rating Scale (NRS)
Description
It contains 11 digits that should be assigned according to the perceived pain intensity on a numerical scale. The participant chooses the number that best reflects his or her pain. In our study, the patients were informed that the '0' point was not pain at all, and the '10' point expressed unbearable pain.
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Roland-Morris Disability Questionnaire
Description
It is a questionnaire developed to evaluate functional disabilities in patients with low back pain. Turkish validity and reliability study was conducted in 2001 (20). In the 24-sentence questionnaire about functional impairments, patients are asked to answer each sentence as yes if it fits their situation, and no if it does not. Yes responses are calculated as "1" and no answers are calculated as "0" points. In this questionnaire with a total score between 0-24, the higher score means more disability.
Time Frame
two weeks
Title
Euroqol Quality Of Life Scale
Description
EQ-5D is a self-report scale developed by the EuroQoL group, the Western European quality of life research community, and evaluates five dimensions with 1 question each. These five dimensions consist of subtitles of mobility, self-care, usual daily activities, pain / discomfort and anxiety / depression. The answers given to each dimension have 3 options: no problem, some problem and major problem. As a result, 243 possible different health outcomes are defined with the scale. An index score ranging from -0.59 to 1 is calculated from the 5 dimensions of the scale. In the score function, a value of 0 indicates death, a value of 1 indicates perfect health, while negative values indicate unconsciousness, living dependent on bed, etc. show situations. Also included in the scale is a VAS (EQ-VAS) that includes answers between 0 and 100, ie "0 = the worst health condition imaginable" and "100 = the best health condition imaginable".
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being diagnosed with nonspecific low back pain Symptom onset with more than 3 months Exclusion Criteria: History of surgery on low back region Structural deformity on the low back region Radiculopathy Tumor or malignancy Any skin condition that prevents usage of electrotherapy Having a pace maker or other types of implants on the low back, pelvis and thoracic region
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Fatih Yaşar, MD
Organizational Affiliation
Bolu Abant Izzet Baylsa University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ramazan KURUL, Ph.D
Organizational Affiliation
Bolu Abant Izzet Baylsa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Sciences Bolu Abant Izzet Baysal University
City
Bolu
State/Province
Merkez
ZIP/Postal Code
14100
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Comparison of Two Electrotherapy Methods on Chronic Low Back Pain

We'll reach out to this number within 24 hrs