Olive Oil Phonophoresis and Chronic Low Back

January 17, 2013 updated by: Shahab Bohlooli, Ardabil University of Medical Sciences

The Effect of Olive Oil Phonophoresis on Chronic Low Back Pain in Female Athletes: a Randomized Controlled Trial

This study is intended to evaluate the effect of olive oil phonophoresis on chronic law back pain in female athletes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study will enroll 60 female patients suffering from chronic low back pain. the study will run in single blind mode that only patients will kept unaware of treatment.

The duration of treatment is 10 days. patients will be assigned randomly to olive oil or placebo group. every day, they will take phonophoresis on lower back using phonophoresis gel as placebo or olive oil as treatment for 10 day. the questionnaires will be filled in baseline visit and day 10. any side effect of drugs or technique will be recorded

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Locations

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Young female athletes suffering from low back pain for more than three months

Exclusion Criteria:

  • Underlying systematic or visceral disease
  • Specific conditions such as neoplasm and fractures, spondylolisthesis
  • Previous low back surgery
  • Pregnancy

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Phonophoresis Gel
The Phonophoresis gel will be used as placebo
Drug: Phonophoresis gel
Phonophoresis with base gel for 10 days, daily
Experimental: Olive Oil
Olive oil will be used as a replacement to phonophoresis gel in this arm
Dietary supplement: Olive oil
Phonophoresis with Olive oil for 10 day, daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: Change from Baseline in McGill Low Back Pain Scale at day 10
Low back pain intensity will be measured using McGill questionnaire from 0 (no pain) to 10 (worst).
Change from Baseline in McGill Low Back Pain Scale at day 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical function
Time Frame: Change from Baseline in Phycical Function Scale at Day 10
The ability of patients in doing daily activities will be measured using two qualified questionnaires
Change from Baseline in Phycical Function Scale at Day 10

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: Day 10
Any occurrence of drug induced side effects will be recorded
Day 10

Collaborators and Investigators

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

Sponsor

Ardabil University of Medical Sciences

Collaborators

Islamic Azad University, Tehran

Investigators

  • Principal Investigator: Shahab Bohlooli, PhD, Department of Pharmacology, School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran

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

January 1, 2013

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 17, 2013

First Posted (Estimate)

January 21, 2013

Study Record Updates

Last Update Posted (Estimate)

January 21, 2013

Last Update Submitted That Met QC Criteria

January 17, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1391/7/18

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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