Effect of Ultrasound and Laser in Chronic Low Back Pain: Randomized Double-blinded Controled Trial

Low Back Pain Clinical Trial

Official title:

Effect of Laser and Ultrasound in Pain and Disability in Women With Chronic Non-specific Low Back Pain: Randomized Double-blinded Controled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02210520
• Other study ID #: São Lucas College
• Status: Recruiting
• Phase: Phase 1
• First received: July 11, 2014
• Last updated: August 4, 2014
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2014
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The low level laser therapy has a better effect in decrease the pain than ultrasound therapeutic.

Description:

The laser will be applied with the dosimetry 3 J/cm², 2 minutes in 6 points around the back spine, during 4 weeks. Before the women will be evaluate again.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• chronic low back pain

• 3,0 - 7,0 in the visual analogic scale

Exclusion Criteria:

• no use of medications

• no other treatment

• without fractures, pregnancy, psychiatric or neurologic disorders, diabetes, amputations

• with diagnostic of low back pain

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• pulsatile ultrasound
1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.
• continuous ultrasound
1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.
• laser
1 W/cm², 2 minutes in 6 points around the back spine

Locations

Country	Name	City	State
Brazil	São Lucas College	Porto Velho	Rondõnia

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Visual Analog Scale	4 weeks	Yes
Secondary	Pain quality	McGill questionaire	4 weeks	Yes
Secondary	Disability	Roland Morris Questionaire	4 Weeks	Yes