NCT01772433

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_2 low-back-pain

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_2 low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

8 months

First QC Date

January 15, 2013

Last Update Submit

January 17, 2013

Conditions

Low Back Pain

Keywords

Low Back PainTopical Olive OilPhonophoresis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Physical function

    Change from Baseline in Phycical Function Scale at Day 10

Other Outcomes (1)

  • Safety

    Day 10

Study Arms (2)

Phonophoresis Gel

PLACEBO COMPARATOR

The Phonophoresis gel will be used as placebo

Drug: Phonophoresis gel

Olive Oil

EXPERIMENTAL

Olive oil will be used as a replacement to phonophoresis gel in this arm

Dietary Supplement: Olive oil

Interventions

Olive oilDIETARY_SUPPLEMENT

Phonophoresis with Olive oil for 10 day, daily

Olive Oil
Phonophoresis gelDRUG

Phonophoresis with base gel for 10 days, daily

Phonophoresis Gel

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Young female athletes suffering from low back pain for more than three months

You may not qualify if:

  • Underlying systematic or visceral disease
  • Specific conditions such as neoplasm and fractures, spondylolisthesis
  • Previous low back surgery
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Physiotherpay

Ardabil, Ardabil Province, 56197, Iran

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Shahab Bohlooli, PhD

    Department of Pharmacology, School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahab Bohlooli, PhD

CONTACT

shahab.bohlooli@arums.ac.ir

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 21, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

January 21, 2013

Record last verified: 2013-01

Locations

IR(1)