Optimizing Chronic Low Back Pain Exercise Therapies With Cerebral Electrical Stimulation

Chronic Low Back Pain Clinical Trial

Official title:

Optimizing Chronic Low Back Pain Exercise Therapies With Cerebral Electrical Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503422
• Other study ID #: tDCS and low back exercise
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 10, 2018
• Est. completion date: January 15, 2021

Study information

• Verified date: January 2021
• Source: Universidade Federal do Piauí
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic low back (CLBP) pain is an important public health and socioeconomic problem worldwide and, despite the volume of research in the area, it remains a difficult condition to treat. The Neuromatrix pain model and new findings on the pain chronification process point to a greater efficacy of treatments that address central and peripheral rather than only peripheral structures.

Transcranial direct current (tDCS) stimulation is a noninvasive neuromodulation technique that has been presenting recent advances in the treatment of chronic pain. However, when applied alone the magnitude of its effect is small in chronic musculoskeletal conditions such as chronic non-specific back pain. One option that could optimize the analgesic effect of tDCS would be the combination with therapeutic exercises, which play a central role in spinal rehabilitation programs as well as higher levels of evidence. The combination of these treatments (tDCS and exercise) may present an analgesic effect superior to the isolated interventions.

This study aims to investigate the efficacy of tDCS combined with therapeutic exercises in people CLBP for pain relief, affective aspect of pain, disability, kinesiophobia and global perception. Sixty patients will be randomized into two distinct groups to receive either tDCS (anodal) + therapeutic exercises or tDCS (sham) + therapeutic exercises for 12 sessions over a four-week period. The primary clinical outcome (pain relief) and secondary outcomes (disability, affective aspect of pain, kinesiophobia, and perception of overall effect) will be collected before treatment and four weeks, three months and six months post randomization. The data will be collected by a blind examiner to the treatment allocation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 15, 2021
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

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Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain
• Low Back Pain, Recurrent

Intervention

Procedure:
• Real transcranial direct current stimulation + therapeutic exercises for back pain
Real transcranial direct current stimulation associated with therapeutic exercises for back pain tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).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.
• Sham transcranial direct current stimulation + therapeutic exercises for back pain
Sham transcranial direct current stimulation associated with therapeutic exercises for back pain. tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). 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

Locations

Country	Name	City	State
Brazil	Department of Physical Therapy. Federal University of Piaui	Parnaiba	PIaui

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Piauí	Foundation for Research Support of the State of Piauí

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.; The VAS for general anxiety is assessed by a horizontal 100-mm-long line. The extreme left end points to no anxiety, and the extreme right end to the worst anxiety possible.	4 weeks, 3 and 6 months after randomization
Other	Depression	Beck depression inventory (BDI) for depressive symptoms that we tracked as possible confounding factor.; The BDI is a tool of self-assessment of de- pression using a questionnaire with 21 items whose in- tensity varies from 0 to 3 (higher scores indicating more depressive symptoms).	4 weeks, 3 and 6 months after randomization
Primary	Pain intensity	Pain intensity will be evaluated by numerical rating scale (0-10).	Four weeks after randomization
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
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
Secondary	Tampa Scale for Kinesiophobia	Irrational, and debilitating fear of movement and activity resulting from a feeling of vulnerability to painful injury or re-injury. Its a 17-item scale.	4 weeks, 3 and 6 months after randomization
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