Low Back Pain, RecurrentPhase 2/3NCT03503422
Optimizing Chronic Low Back Pain Exercise Therapies With Cerebral Electrical Stimulation
A Phase 2/3 study testing Real transcranial direct current stimulation + therapeutic exercises for back pain in people with Low Back Pain, Recurrent and Chronic Low Back Pain, run by Universidade Federal do Piauí at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Recurrent, Chronic Low Back Pain
- What is being tested?
- Real transcranial direct current stimulation + therapeutic exercises for back pain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Apr 2018to 15 Jan 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. -
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Physical Therapy. Federal University of Piaui
Parnaíba, Piauí, 64202-020
About this study
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.
- Conditions
- Low Back Pain, Recurrent, Chronic Low Back Pain
- Being tested
- Real transcranial direct current stimulation + therapeutic exercises for back pain, Sham transcranial direct current stimulation + therapeutic exercises for back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real transcranial direct current stimulation + therapeutic exercises for back painProcedure or surgery
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 painProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| tDCS (anodal) + therapeutic exercises | Experimental | Real transcranial direct current stimulation associated with therapeutic exercises
tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). Receives: Procedure: Real transcranial direct current stimulation + therapeutic exercises for back pain |
| tDCS (sham) + therapeutic exercises | Sham comparator | Sham transcranial direct current stimulation associated with therapeutic exercises
tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). Receives: Procedure: Sham transcranial direct current stimulation + therapeutic exercises for back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be evaluated by numerical rating scale (0-10).
Measured: Four weeks after randomization
Secondary outcomes (4)
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.
Measured: 4 weeks, 3 and 6 months after randomization
Disability
The Roland Morris disability questionnaire (RMDQ) is composed of 24 yes or no questions designed to assess disability related to back pain.
Measured: 4 weeks, 3 and 6 months after randomization
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.
Measured: 4 weeks, 3 and 6 months after randomization
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 first started, how would you describe your back these days. A higher score indicates higher recovery from the condition.
Measured: 4 weeks, 3 and 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start10 Apr 2018
- Primary completion10 Feb 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Piauí
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Research Support of the State of Piauí
- Responsible party
- Principal investigator, Fuad Ahmad Hazime, Universidade Federal do Piauí
- Investigators
- Fuad A Hazime, PhD, Principal investigator, Federal University of Piaui
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503422
- Sponsor's protocol ID
- tDCS and low back exercise
- Status last verified
- Jan 2021
- First submitted
- 11 Apr 2018
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cavalcante PGL, Baptista AF, Cardoso VS, Filgueiras MC, Hasue RH, Joao SMA, Hazime FA. Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Chronic Low Back Pain: Protocol of a Randomized Controlled Trial. Phys Ther. 2020 Aug 31;100(9):1595-1602. doi: 10.1093/ptj/pzaa105.
PubMed 32526017
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Chronic Low Back Pain Exercise Therapies With Cerebral Electrical Stimulation
- ClinicalTrials.gov ID
- NCT03503422
- Acronym / sponsor ID
- tDCS and low back exercise
- Conditions
- Low Back Pain, Recurrent, Chronic Low Back Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade Federal do PiauíUniversity, hospital or other
- Collaborators
- Foundation for Research Support of the State of Piauí
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS (anodal) + therapeutic exercises | Experimental | Procedure: Real transcranial direct current stimulation + therapeutic exercises for back painReal transcranial direct current stimulation associated with therapeutic exercises tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). |
| tDCS (sham) + therapeutic exercises | Sham comparator | Procedure: Sham transcranial direct current stimulation + therapeutic exercises for back painSham transcranial direct current stimulation associated with therapeutic exercises tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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. -
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real transcranial direct current stimulation + therapeutic exercises for back painReal 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. | Procedure or surgery | tDCS (anodal) + therapeutic exercises |
| Sham transcranial direct current stimulation + therapeutic exercises for back painSham 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 | Procedure or surgery | tDCS (sham) + therapeutic exercises |
Primary outcome
Pain intensity
Time frame: Four weeks after randomization
Pain intensity will be evaluated by numerical rating scale (0-10).
4 secondary outcomes
Quality of pain
Time frame: 4 weeks, 3 and 6 months after randomization
Disability
Time frame: 4 weeks, 3 and 6 months after randomization
Tampa Scale for Kinesiophobia
Time frame: 4 weeks, 3 and 6 months after randomization
Global perceived effect (GPE)
Time frame: 4 weeks, 3 and 6 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Derived from this study: PubMed 32526017Cavalcante PGL, Baptista AF, Cardoso VS, Filgueiras MC, Hasue RH, Joao SMA, Hazime FA. Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Chronic Low Back Pain: Protocol of a Randomized Controlled Trial. Phys Ther. 2020 Aug 31;100(9):1595-1602. doi: 10.1093/ptj/pzaa105.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fuad A Hazime, PhD principal investigator
Federal University of Piaui
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Real transcranial direct current stimulation + therapeutic exercises for back pain in people with Low Back Pain, Recurrent and Chronic Low Back Pain, run by Universidade Federal do Piauí at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Four weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03503422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.