Back to resultsOlive Oil Phonophoresis and Chronic Low Back
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Olive oil
Phonophoresis gel
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Topical Olive Oil, Phonophoresis
Eligibility 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
Sites / Locations
- Clinic of PhysiotherpayRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Phonophoresis Gel
Olive Oil
Arm Description
The Phonophoresis gel will be used as placebo
Olive oil will be used as a replacement to phonophoresis gel in this arm
Outcomes
Primary Outcome Measures
Pain Score
Low back pain intensity will be measured using McGill questionnaire from 0 (no pain) to 10 (worst).
Secondary Outcome Measures
Physical function
The ability of patients in doing daily activities will be measured using two qualified questionnaires
Full Information
NCT ID
NCT01772433
First Posted
January 15, 2013
Last Updated
January 17, 2013
Sponsor
Ardabil University of Medical Sciences
Collaborators
Islamic Azad University, Tehran
1. Study Identification
Unique Protocol Identification Number
NCT01772433
Brief Title
Olive Oil Phonophoresis and Chronic Low Back
Official Title
The Effect of Olive Oil Phonophoresis on Chronic Low Back Pain in Female Athletes: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ardabil University of Medical Sciences
Collaborators
Islamic Azad University, Tehran
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is intended to evaluate the effect of olive oil phonophoresis on chronic law back pain in female athletes.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain, Topical Olive Oil, Phonophoresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phonophoresis Gel
Arm Type
Placebo Comparator
Arm Description
The Phonophoresis gel will be used as placebo
Arm Title
Olive Oil
Arm Type
Experimental
Arm Description
Olive oil will be used as a replacement to phonophoresis gel in this arm
Intervention Type
Dietary Supplement
Intervention Name(s)
Olive oil
Intervention Description
Phonophoresis with Olive oil for 10 day, daily
Intervention Type
Drug
Intervention Name(s)
Phonophoresis gel
Intervention Description
Phonophoresis with base gel for 10 days, daily
Primary Outcome Measure Information:
Title
Pain Score
Description
Low back pain intensity will be measured using McGill questionnaire from 0 (no pain) to 10 (worst).
Time Frame
Change from Baseline in McGill Low Back Pain Scale at day 10
Secondary Outcome Measure Information:
Title
Physical function
Description
The ability of patients in doing daily activities will be measured using two qualified questionnaires
Time Frame
Change from Baseline in Phycical Function Scale at Day 10
Other Pre-specified Outcome Measures:
Title
Safety
Description
Any occurrence of drug induced side effects will be recorded
Time Frame
Day 10
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahab Bohlooli, PhD
Email
shahab.bohlooli@arums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahab Bohlooli, PhD
Organizational Affiliation
Department of Pharmacology, School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of Physiotherpay
City
Ardabil
ZIP/Postal Code
56197
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahab Bohlooli, PhD
Email
shahab.bohlooli@arums.ac.ir
First Name & Middle Initial & Last Name & Degree
Babak Nakhostin-roohi, PhD
Email
bnakhostin_aau@yahoo.com
First Name & Middle Initial & Last Name & Degree
Babak Nakhostin-roohi, PhD
First Name & Middle Initial & Last Name & Degree
Shahab Bohlooli, PhD
12. IPD Sharing Statement
Learn more about this trial
Olive Oil Phonophoresis and Chronic Low Back
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