Effect of Interferential l Therapy on Low Back Pain

NCT ID: NCT03961477

Last Updated: 2019-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-05

Study Completion Date

2018-09-23

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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IF group

Interferential therpapy

Group Type ACTIVE_COMPARATOR

Interferential therapy

Intervention Type OTHER

Exercise therapy

Placebo

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Interferential therapy

Exercise therapy

Intervention Type OTHER

Other Intervention Names

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Exercise therapy

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Ahlia University

OTHER

Sponsor Role lead

Responsible Party

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Dr Sayed Tantawy

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sayed A Tantawy, PhD

Role: STUDY_DIRECTOR

Cairo University

Locations

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Dr Dalia Kamel

Giza, , Egypt

Site Status

Dr Sayed Tanatwy

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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P.T REC/012/001811

Identifier Type: -

Identifier Source: org_study_id

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