Brain and Peripheral Electrical Stimulation in Chronic Low Back Pain: a Factorial Design

Chronic Low Back Pain Clinical Trial

Official title:

Treatment of Chronic Non-specific Low Back Pain With Brain and Peripheral Electrical Stimulation: a Factorial, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896453
• Other study ID #: tDCSBACKPAIN
• Secondary ID: USaoPauloGH
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 19, 2013
• Last updated: December 3, 2014
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2013
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of brain and peripheral electrical stimulation on chronic non-specific low back pain patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males and females aged > 18 years and <65 years

• Complaining of back pain for more than three months

• Presence of a chronic pain measurable with the number rating scale (NRS 0-10) not less than 4 during a 1 week daily NRS monitoring

• Seeking care for low back pain

Exclusion Criteria:

• Previous surgery on the spine, spondylolisthesis

• Previous treatment with TENS <6 months

• Previous treatment with tDCS

• Disc herniation with nerve compression

• Neurological, psychiatric and rheumatologic diseases

• Impaired sensibility

• Use of pacemakers or other implanted devices

• Pregnancy

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Transcranial direct current stimulation (tDCS)
Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively
• Transcutaneous electrical nerve stimulation (TENS)
Technique based on the application of low-voltage electrical current to the skin through relatively large electrodes that are placed over the pain area.

Locations

Country	Name	City	State
Brazil	School of Physiotherapy - University of São Paulo	São Paulo

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	Anxiety	Visual analogue scale (VAS)for anxiety assesses anxiety symptoms that we tracked as possible confounding factor.	4 weeks, 3 and 6 months after randomization.	No
Other	Depression	Beck depression inventory (BDI) for depressive symptoms that we tracked as possible confounding factor.	4 weeks, 3 and 6 months after randomization	No
Other	Satisfaction with care	Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care.	4 weeks after randomization	No
Primary	Pain intensity	Pain intensity will be evaluated by numerical rating scale (0-10).	Four weeks after randomization	No
Secondary	Disability	The Roland Morris disability questionnaire (RMDQ) is composed of 24 yes or no questions designed to assess disability related to back pain.	4 weeks, 3 and 6 months after randomization.	No
Secondary	Quality of pain	The Short form of the McGill pain questionnaire (SF-MPQ) consists of 15 representative words from the sensory and affective categories of the standard long form. The 6 point intensity scale and a VAS are included to provide indices of overall pain intensity.	4 weeks, 3 and 6 months after randomization.	No
Secondary	Global perceived effect (GPE)	Global perceived effect is an 11 point scale that ranges from 5 (vastly worse) through 0 (no change) to 5 (completely recovered). For all measures of global perceived effect (at baseline and all follow-ups), participants were asked compared to when this episode ?rst started, how would you describe your back these days. A higher score indicates higher recovery from the condition.	4 weeks, 3 and 6 months after randomization.	No
Secondary	Pain intensity	Pain intensity will be evaluated by numerical rating scale (0-10)	3 and 6 months after randomization	No