Effect of Interferential l Therapy on Low Back Pain ([PTREC])

May 22, 2019 updated by: Dr Sayed Tantawy, Ahlia University

Effect of Interferential Therapy on Pain, Range of Motion and Quality of Life in Patients With Chronic Non-specific Low Back Pain: A Randomized Controlled Trial

Background: Chronic non-specific low back pain is defined as unknown mechanical musculoskeletal pain lasting more than 3 months. Electrotherapy is a non-pharmacologic, non-invasive and simple method back pain treatment that is mainly applied using interferential (IF) therapy. The current study was designed to investigate the effect of IF on pain, range of motion, and quality of life in patients with chronic non-specific low back pain. Materials and methods: 61 patients suffered from chronic non-specific low back pain (CNLBP) were randomly assigned to IF group (n=30) and placebo IF (n=31). The entire patient received suggested exercise 3 times per week for 4 weeks. The outcome measures were visual analogue scale (VAS), lumbar range of motion (ROM) in terms of flexion& extension and the Short Form-36 (SF-36) health questionnaire to evaluate the quality of life (QOL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants The study was conducted in outpatient clinics in Cairo University Hospitals. 60 patients (29 males and 31 females) were invited to participate in the current study. Subjects were included in the study if they had LBP of at least three months duration and aged between 25 and 60 years. Patients with spinal pathology (tumor, nerve root, fracture, and compromise), cardiopulmonary conditions, pregnancy, and received physiotherapy in the last eight weeks or any contraindications to the use of electrotherapy were excluded.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Dr Dalia Kamel
      • Giza, Egypt
        • Dr Sayed Tanatwy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

*Subjects were included in the study if they had LBP of at least three months duration * Age between 25 and 60 years.

Exclusion Criteria:

  • Patients with spinal pathology (tumor, nerve root, fracture, and compromise),
  • Cardiopulmonary conditions
  • Pregnancy,
  • Received physiotherapy in the last eight weeks
  • Any contraindications to the use of electrotherapy were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IF group
Interferential therpapy
Other: Interferential therapy
Exercise therapy
Other Names:
  • Exercise therapy
No Intervention: Placebo
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: 6 months
The severity of pain was evaluated using a visual analogue scale (VAS). The participants were requested to put a line on the scale perpendicularly that matched to their pain intensity. VAS scores represent the pain intensity as none, mild, moderate, or severe. The accompanying cutoff was used for the pain scale: 0- 4 , no pain; 5- 44, mild pain; 45- 74, moderate pain; and 75-100, severe pain
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahlia University

Collaborators

Cairo University

Investigators

  • Study Director: Sayed A Tantawy, PhD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2017

Primary Completion (Actual)

July 11, 2018

Study Completion (Actual)

September 23, 2018

Study Registration Dates

First Submitted

May 21, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (Actual)

May 23, 2019

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 22, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T REC/012/001811

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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