Comparison of Two Electrotherapy Methods on Chronic Low Back Pain

NCT ID: NCT04859842

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-21
• Study Completion Date: 2022-12-30

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

Conditions

Low Back Pain, Mechanical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pulse Electromagnetic Field Group

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.

Group Type: ACTIVE_COMPARATOR

Pulse Electromagnetic Field

Intervention Type: OTHER

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.

Interferential Current Group

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.

Group Type: ACTIVE_COMPARATOR

Interferential Current

Intervention Type: OTHER

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.

Sham Group

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.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: OTHER

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.

Interventions

Pulse Electromagnetic Field

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

Interferential Current

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

Sham

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Ramazan KURUL

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mustafa Fatih Yaşar, MD

Role: PRINCIPAL_INVESTIGATOR

Bolu Abant Izzet Baylsa University

Ramazan KURUL, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Bolu Abant Izzet Baylsa University

Locations

Faculty of Health Sciences Bolu Abant Izzet Baysal University

Bolu, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AIBU-FTR-RK-06

Identifier Type: -

Identifier Source: org_study_id