Olive Oil Phonophoresis and Chronic Low Back

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Ardabil University of Medical Sciences
Sponsor:
Collaborator:
Islamic Azad University, Tehran
Information provided by (Responsible Party):
Shahab Bohlooli, Ardabil University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01772433
First received: January 15, 2013
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Low Back Pain
Dietary Supplement: Olive oil
Drug: Phonophoresis gel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effect of Olive Oil Phonophoresis on Chronic Low Back Pain in Female Athletes: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Ardabil University of Medical Sciences:

Primary Outcome Measures:
  • Pain Score [ Time Frame: Change from Baseline in McGill Low Back Pain Scale at day 10 ] [ Designated as safety issue: No ]
    Low back pain intensity will be measured using McGill questionnaire from 0 (no pain) to 10 (worst).


Secondary Outcome Measures:
  • Physical function [ Time Frame: Change from Baseline in Phycical Function Scale at Day 10 ] [ Designated as safety issue: No ]
    The ability of patients in doing daily activities will be measured using two qualified questionnaires


Other Outcome Measures:
  • Safety [ Time Frame: Day 10 ] [ Designated as safety issue: Yes ]
    Any occurrence of drug induced side effects will be recorded


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772433

Contacts
Contact: Shahab Bohlooli, PhD shahab.bohlooli@arums.ac.ir

Locations
Iran, Islamic Republic of
Clinic of Physiotherpay Recruiting
Ardabil, Iran, Islamic Republic of, 56197
Contact: Shahab Bohlooli, PhD       shahab.bohlooli@arums.ac.ir   
Contact: Babak Nakhostin-roohi, PhD       bnakhostin_aau@yahoo.com   
Sub-Investigator: Babak Nakhostin-roohi, PhD         
Principal Investigator: Shahab Bohlooli, PhD         
Sponsors and Collaborators
Ardabil University of Medical Sciences
Islamic Azad University, Tehran
Investigators
Principal Investigator: Shahab Bohlooli, PhD Department of Pharmacology, School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran
  More Information

No publications provided

Responsible Party: Shahab Bohlooli, Dr, Ardabil University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01772433     History of Changes
Other Study ID Numbers: 1391/7/18
Study First Received: January 15, 2013
Last Updated: January 17, 2013
Health Authority: Iran: Ministry of Health

Keywords provided by Ardabil University of Medical Sciences:
Low Back Pain
Topical Olive Oil
Phonophoresis

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014