Effect of Interferential l Therapy on Low Back Pain | NCT03961477

Studies
Effect of Interferential l Therapy on Low Back Pain

NCT03961477

Sponsor

Ahlia University

Status

Completed

Last Update Posted

May 23, 2019Actual

Enrollment

61Actual

Phase

Not Applicable

Conditions

Low Back Pain

Interventions

Interferential therapy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2017Actual

Primary Completion Date

Jul 11, 2018Actual

Completion Date

Sep 23, 2018Actual

First Submitted Date

May 21, 2019

First Submission Date that Met QC Criteria

May 22, 2019

First Posted Date

May 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2019

Last Update Posted Date

May 23, 2019Actual

Name	Class
Cairo University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IF group	Active Comparator	Interferential therpapy	Other: Interferential therapy
Placebo	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interferential therapy	Other	Exercise therapy	IF group	Exercise therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sayed A Tantawy, PhD	Cairo University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr Dalia Kamel		Giza			Egypt
Dr Sayed Tanatwy

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004599	Electric Stimulation Therapy
D005081	Exercise Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation
D000359	Aftercare

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Double

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.

Who Masked

ParticipantOutcomes Assessor