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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Interferential therapy
Sponsored by
Ahlia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain,, Interferential Therapy, Quality of Life

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr Dalia Kamel
  • Dr Sayed Tanatwy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

IF group

Placebo

Arm Description

Interferential therpapy

No intervention

Outcomes

Primary Outcome Measures

Visual Analogue Scale (VAS)
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

Secondary Outcome Measures

Full Information

First Posted
May 21, 2019
Last Updated
May 22, 2019
Sponsor
Ahlia University
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03961477
Brief Title
Effect of Interferential l Therapy on Low Back Pain
Acronym
[PTREC]
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 5, 2017 (Actual)
Primary Completion Date
July 11, 2018 (Actual)
Study Completion Date
September 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahlia University
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Each subject in both groups was positioned in prone lying and the area to be treated was exposed. The IF group which included 30 subjects received IF. The IF current was increased gradually according the subject's condition with comfortable tingling sensation.
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IF group
Arm Type
Active Comparator
Arm Description
Interferential therpapy
Arm Title
Placebo
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Interferential therapy
Other Intervention Name(s)
Exercise therapy
Intervention Description
Exercise therapy
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sayed A Tantawy, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Dr Dalia Kamel
City
Giza
Country
Egypt
Facility Name
Dr Sayed Tanatwy
City
Giza
Country
Egypt

12. IPD Sharing Statement

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Effect of Interferential l Therapy on Low Back Pain

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