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Olive Oil Phonophoresis and Chronic Low Back

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01772433
Recruitment Status : Unknown
Verified January 2013 by Shahab Bohlooli, Ardabil University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : January 21, 2013
Last Update Posted : January 21, 2013
Islamic Azad University, Tehran
Information provided by (Responsible Party):
Shahab Bohlooli, Ardabil University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Low Back Pain Dietary Supplement: Olive oil Drug: Phonophoresis gel Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Olive Oil Phonophoresis on Chronic Low Back Pain in Female Athletes: a Randomized Controlled Trial
Study Start Date : January 2013
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
Drug Information available for: Olive oil

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

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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

Other Outcome Measures:
  1. Safety [ Time Frame: Day 10 ]
    Any occurrence of drug induced side effects will be recorded

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01772433

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Contact: Shahab Bohlooli, PhD

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Iran, Islamic Republic of
Clinic of Physiotherpay Recruiting
Ardabil, Iran, Islamic Republic of, 56197
Contact: Shahab Bohlooli, PhD   
Contact: Babak Nakhostin-roohi, PhD   
Sub-Investigator: Babak Nakhostin-roohi, PhD         
Principal Investigator: Shahab Bohlooli, PhD         
Sponsors and Collaborators
Ardabil University of Medical Sciences
Islamic Azad University, Tehran
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Principal Investigator: Shahab Bohlooli, PhD Department of Pharmacology, School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran

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Responsible Party: Shahab Bohlooli, Dr, Ardabil University of Medical Sciences Identifier: NCT01772433    
Other Study ID Numbers: 1391/7/18
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013
Keywords provided by Shahab Bohlooli, Ardabil University of Medical Sciences:
Low Back Pain
Topical Olive Oil
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms