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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Other: pulsed ultrasound group; Other: low level laser therapy group; Other: continuous ultrasound group

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rondônia
    • Porto Velho, Rondônia, Brazil, 76804070
      • Sâo Lucas College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: 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; Other Names: Sonopulse III; Ibramed; 1 MHz and 3 MHz of frequency; Other: 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; Other Names: Ibramed; Laserpulse; 904 nm
Active Comparator: 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	Other: 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; Other Names: Ibramed; Laserpulse; 904 nm; 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; Other Names: Sonopulse III; Ibramed; 1 MHz and 3 MHz of frequency
Active Comparator: low level laser therapy group; the group will be treated with 3J during 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine	Other: 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; Other Names: Sonopulse III; Ibramed; 1 MHz and 3 MHz of frequency; 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; Other Names: Sonopulse III; Ibramed; 1 MHz and 3 MHz of frequency
No Intervention: control group; group of women no treated, only evaluated in two moments and this group will be compared with orthers: laser, pulsed ultrasound and continuous ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: ANA PAULA RUBIRA, MASTER, Sao Paulo University

Publications and helpful links

General Publications

• Rubira APFA, Rubira MC, Rubira LA, Comachio J, Magalhaes MO, Marques AP. Comparison of the effects of low-level laser and pulsed and continuous ultrasound on pain and physical disability in chronic non-specific low back pain: a randomized controlled clinical trial. Adv Rheumatol. 2019 Dec 17;59(1):57. doi: 10.1186/s42358-019-0099-z.
• de Resende Guimaraes MFB, Rodrigues CEM, Gomes KWP, Machado CJ, Brenol CV, Krampe SF, de Andrade NPB, Kakehasi AM. High prevalence of obesity in rheumatoid arthritis patients: association with disease activity, hypertension, dyslipidemia and diabetes, a multi-center study. Adv Rheumatol. 2019 Oct 16;59(1):44. doi: 10.1186/s42358-019-0089-1.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: March 7, 2014
• First Submitted That Met QC Criteria: May 25, 2014
• First Posted (Estimate): May 29, 2014

Study Record Updates

• Last Update Posted (Estimate): May 29, 2014
• Last Update Submitted That Met QC Criteria: May 25, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: clinical trial; women; disability; chronic non-specific low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CEP 390/10