Laser and Therapeutic Ultrasound in the Management of the Chronic Non-specific Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

Laser and and Ultrasound Effect on Pain and Disability in Women With Chronic Non-specific Low Back Pain: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02150096
• Other study ID #: CEP 390/10
• Status: Not yet recruiting
• Phase: N/A
• First received: March 7, 2014
• Last updated: May 25, 2014
• Start date: May 2014
• Est. completion date: July 2014

Study information

• Verified date: May 2014
• Source: University of Sao Paulo General Hospital
• Contact: ANA PAULA F A RUBIRA, Ms
• Phone: 55 069 92070778
• Email: anapaularubira[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The objective of this study is evaluate the laser and ultrasound effect on pain and disability in women with non-specific chronic low back pain.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• non-specific chronic low back pain

• moderate pain

• eutrophics women

Exclusion Criteria:

• disk herniation

• cardiac diseases

• psychiatrics diseases

• endocrinous diseases

• fractures of the spine

• fractures of lower members

• diabetics

• dental emergency

• local infections

• local non sensibility

• analgesics and anti-inflammatories in use

• neurologic diseases

• pregnancy

Study Design

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• continuous ultrasound group
the group will be treated with 1,5 W/cm² 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine
• pulsed ultrasound group
the group will be treated with 1,5 W/cm² 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine
• low level laser therapy group
the group will be treated with 3 J 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine

Locations

Country	Name	City	State
Brazil	Sâo Lucas College	Porto Velho	Rondônia

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
Other	Multidimensional evaluation of pain	The McGill questionaire will be used for the evaluation.	The multidimensional evaluation of pain will be realized before and after 25 days of the treatment	Yes
Primary	Pain evaluation	The visual analogic scale will be used for evaluate the pain.	The pain will be evaluate before and after 25 days of the treatment	Yes
Secondary	Disability evaluation	The Roland Morris questionaire will be used to evaluate the disability.	The disability will be evaluate before and after 25 days of the treatment	Yes