- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03961477
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
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
-
-
-
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
|
Exercise therapy
Other Names:
|
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
Collaborators
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
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.
Clinical Trials on Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
-
Universidade Federal do PiauíFoundation for Research Support of the State of PiauíCompletedLow Back Pain, Recurrent | Chronic Low Back PainBrazil
-
Washington University School of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedChronic Low Back Pain | Mechanical Low Back PainUnited States
-
University of ExtremaduraCompletedChronic Low Back Pain | Postural Low Back PainSpain
-
Université du Québec à Trois-RivièresCompletedChronic Low Back Pain | Mechanical Low Back PainCanada
Clinical Trials on Interferential therapy
-
Universidade Cidade de Sao PauloCompleted
-
Montefiore Medical CenterOrtho IFC LLCCompletedOsteo Arthritis KneeUnited States
-
Hospital Universitario Ramon y CajalCompletedCarpal Tunnel Syndrome | Neuropathic PainSpain
-
Taibah UniversityCompletedBladder Dysfunction on Patients With Multiple SclerosisSaudi Arabia
-
University of Nove de JulhoCompleted
-
Hospital de Clinicas de Porto AlegreUniversity of BrasiliaCompletedDecreased Vascular FlowBrazil
-
Luis Espejo Antúnez PhDCompletedTemporomandibular DisordersSpain
-
Cairo UniversityCompleted
-
Neuro Counsel Hospital, PakistanCompleted
-
King Saud UniversityBurdwan Institute of Medical and Life Sciences (BIMLS)CompletedKnee OsteoarthritisSaudi Arabia