Comparison of Two Electrotherapy Methods on Chronic Low Back Pain

NCT04859842 | Completed

• 1 other identifier: AIBU-FTR-RK-06
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain, Mechanical

Keywords

Rehabilitation; Electric Stimulation Therapy; Quality of Life; Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  two weeks

Secondary Outcomes (2)

• Roland-Morris Disability Questionnaire

  two weeks

• Euroqol Quality Of Life Scale

  two weeks

Study Arms (3)

Pulse Electromagnetic Field Group

ACTIVE COMPARATOR

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.

Other: Pulse Electromagnetic Field

Interferential Current Group

ACTIVE COMPARATOR

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.

Other: Interferential Current

Sham Group

SHAM COMPARATOR

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.

Other: Sham

Interventions

Pulse Electromagnetic Field 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.

Pulse Electromagnetic Field Group

Interferential Current 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.

Interferential Current Group

Sham 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.

Sham Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Faculty of Health Sciences Bolu Abant Izzet Baysal University

Bolu, Merkez, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Pain

Interventions

Electric Stimulation Therapy; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Mustafa Fatih Yaşar, MD

  Bolu Abant Izzet Baylsa University

  PRINCIPAL INVESTIGATOR

• Ramazan KURUL, Ph.D

  Bolu Abant Izzet Baylsa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Conventional therapy group will receive sham electrotherapy sessions and outcome assessments will be performed by a investigator who was blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Three groups with a conventional therapy control group.

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 26, 2021
• Study Start: April 21, 2021
• Primary Completion: December 21, 2022
• Study Completion: December 30, 2022
• Last Updated: September 25, 2023

Record last verified: 2023-09

Locations

TU (1)