Olive Oil Phonophoresis and Chronic Low Back

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01772433
• Other study ID #: 1391/7/18
• Status: Recruiting
• Phase: Phase 2
• First received: January 15, 2013
• Last updated: January 17, 2013
• Start date: January 2013
• Est. completion date: October 2013

Study information

• Verified date: January 2013
• Source: Ardabil University of Medical Sciences
• Contact: Shahab Bohlooli, PhD
• Email: shahab.bohlooli[@]arums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Dietary Supplement:
• Olive oil
Phonophoresis with Olive oil for 10 day, daily

Drug:
• Phonophoresis gel
Phonophoresis with base gel for 10 days, daily

Locations

Country	Name	City	State
Iran, Islamic Republic of	Clinic of Physiotherpay	Ardabil

Sponsors (2)

Lead Sponsor	Collaborator
Ardabil University of Medical Sciences	Islamic Azad University, Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	Any occurrence of drug induced side effects will be recorded	Day 10	Yes
Primary	Pain Score	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	No
Secondary	Physical function	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	No