Olive Oil Phonophoresis and Chronic Low Back

Phase 2

• Conditions: Low Back Pain
• Interventions: Drug: Phonophoresis gel; Dietary Supplement: Olive oil

• Registration Number: NCT01772433
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2013-01
• Study Start: 2013-01
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-17
• Last Update Submitted: 2013-01-17
• Study First Posted: 2013-01-21
• Last Update Posted: 2013-01-21
• Primary Completion: 2013-09
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phonophoresis Gel	Phonophoresis gel	The Phonophoresis gel will be used as placebo
Olive Oil	Olive oil	Olive oil will be used as a replacement to phonophoresis gel in this arm

Primary Outcome Measures

Name	Time	Method
Pain Score	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

Name	Time	Method
Physical function	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

Trial Locations

Locations (1)

Clinic of Physiotherpay; 🇮🇷 Ardabil, Iran, Islamic Republic of