Low Back PainNCT05467566
Transcranial Direct Current Stimulation Combined With Exercise in Low Back Pain
A study testing Transcranial direct current stimulation in people with Low Back Pain and Transcranial Direct Current Stimulation, run by Universidade Federal do Rio Grande do Norte.
Trial summary
The purpose of this study is to evaluate the effects of transcranial direct current stimulation combined with Pilates based exercise on chronic low back pain. This is a randomized clinical trial composed of two arms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Transcranial Direct Current Stimulation
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Dec 2023
- Phase
- Interventional
- 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
- Men and women with chronic nonspecific low back pain (for more than 12 weeks) and minimum pain intensity of 3 on numerical pain rating scale.
Who cannot join
- diagnosis of fracture and spine pathologies, fibromyalgia, spine surgery in the last year;
- low cognitive level assessed by the Mini Mental State Examination;
- presence of central neurological diseases (such as Parkinson's and stroke) or psychiatric (such as depression or schizophrenia);
- history of epileptic illness;
- seizure history;
- brain implants;
- pacemaker;
- pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of Transcranial Direct Current Stimulation Combined With Pilates Based Exercise in the Treatment of Patients With Chronic Low Back Pain
The purpose of this study is to evaluate the effects of transcranial direct current stimulation combined with Pilates based exercise on chronic low back pain. This is a randomized clinical trial composed of two arms.
Read the detailed description
Chronic low back pain may be associated with pathoanatomical, neurophysiological, physical, psychological and social factors. Treatments that relieve the symptoms of these patients are of great importance to improve the quality of life of these individuals. Thus, this study aims to evaluate the effects of transcranial direct current stimulation combined with Pilates based exercise on chronic low back pain. This is a randomized clinical trial that will be composed of men and women between 18 and 65 years of age, with a history of low back pain for more than 12 weeks and a minimum pain intensity equal to 3 cm on the numerical pain scale. The volunteers will be randomized into two distinct groups: stimulation + exercise group (EG - will perform a Pilates based exercise protocol combined with transcranial direct current stimulation) and sham stimulation + exercise group (SG - will perform the same exercise program combined with sham stimulation). The interventions, regardless of the group, will be carried out three times a week for four weeks. Participants will be submitted to three assessments: the first (T0) will be performed before the treatment protocols; the second (T1) will be performed after the four weeks of intervention; and the third (T2) will be a follow-up one month after the end of the treatment protocol. Pain sensation, functional performance, central sensitization, quality of life, pressure pain threshold, global impression of change, adverse events and medication use will be evaluated. For the statistical analysis, a mixed model ANOVA will be performed for the inter and intragroup comparison, with Tukey's post hoc, considering a significance level of 5%.
- Being tested
- Transcranial direct current stimulation, Sham Transcranial direct current stimulation
- Keywords
- Transcranial Direct Current Stimulation, Low back pain, Exercise, Chronic pain, Combined modality therapy, Motor cortex
- Medical subject headings
- Low Back Pain, Motor Activity, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Exercise protocol + application of active direct current stimulation for 30 minutes.
Sham Transcranial direct current stimulationDevice
Exercise protocol + application of simulation of direct current stimulation for 30 minutes. The stimulator will be turned off after 30 seconds and the volunteers will not receive current for the rest of the session.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation + exercise group | Experimental | 30-minute exercise program (based on Pilates method) combined with active transcranial direct current stimulation. Receives: Device: Transcranial direct current stimulation |
| Sham stimulation + exercise group | Sham comparator | This arm will perform the same procedures of experimental group but the stimulator will be turned off after 30 seconds and the volunteers will not receive current for the rest of the session. Receives: Device: Sham Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity measured by numerical pain rating scale (11 points scale)
Measured: Change from baseline in pain intensity at four weeks after intervention and 1 month of follow-up
Functional performance associated to back pain
Functional performance associated with low back pain measured by Roland Morris Disability Questionnaire (24 itens)
Measured: Change from baseline in functional performance at four weeks after intervention and 1 month of follow-up
Secondary outcomes (6)
Pressure pain threshold
Pressure pain threshold measured by pressure algometer.
Measured: Change from baseline in pressure pain threshold at four weeks after intervention and 1 month of follow-up
Individual quality of life
Measurement of quality of life using SF-36 questionnaire (36 items, divided into 8 subscales)
Measured: Change from baseline in quality of life questionnaires at four weeks after intervention and 1 month of follow-up
Patient global impression of change
Patient global impression of change measured by a scale with seven points, where 1 is equal to no change or worse and 7 is much better.
Measured: Change from baseline in Patient global impression of change at each intervention day and at four weeks of intervention and 1 month of follow-up.
Central Sensitization
Evaluation of Central Sensitization using Central Sensitization Inventory (CSI).The questionnaire is divided into two parts, the first with a score from 0 to 100 measures 25 somatic and emotional symptoms, while the second part relates to specific previous diagnoses.
Measured: Change from baseline of central sensitization at four weeks after intervention and 1 month of follow-up.
Adverse events
Patient perception of any adverse event during the intervention protocol.
Measured: Up to 4 weeks of intervention and 1 month of follow-up.
Use of medications
Patient declaration of medication use.
Measured: Up to 4 weeks of intervention and 1 month of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study startOct 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionDec 2023 (estimated)
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 PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liane de Brito Macedo, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467566
- Sponsor's protocol ID
- LBPETCC22
- Status last verified
- Jul 2022
- First submitted
- 15 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
da Silva AAC, Gomes SRA, do Nascimento RM, Fonseca AK, Pegado R, Souza CG, Macedo LB. Effects of transcranial direct current stimulation combined with Pilates-based exercises in the treatment of chronic low back pain in outpatient rehabilitation service in Brazil: double-blind randomised controlled trial protocol. BMJ Open. 2023 Dec 30;13(12):e075373. doi: 10.1136/bmjopen-2023-075373.
PubMed 38159941
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcranial Direct Current Stimulation Combined With Pilates Based Exercise in the Treatment of Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05467566
- Acronym / sponsor ID
- LBPETCC22
- Keywords
- Transcranial Direct Current Stimulation, Low back pain, Exercise, Chronic pain, Combined modality therapy, Motor cortex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Jul 2022 (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.
The purpose of this study is to evaluate the effects of transcranial direct current stimulation combined with Pilates based exercise on chronic low back pain. This is a randomized clinical trial composed of two arms.
Detailed description
Chronic low back pain may be associated with pathoanatomical, neurophysiological, physical, psychological and social factors. Treatments that relieve the symptoms of these patients are of great importance to improve the quality of life of these individuals. Thus, this study aims to evaluate the effects of transcranial direct current stimulation combined with Pilates based exercise on chronic low back pain. This is a randomized clinical trial that will be composed of men and women between 18 and 65 years of age, with a history of low back pain for more than 12 weeks and a minimum pain intensity equal to 3 cm on the numerical pain scale. The volunteers will be randomized into two distinct groups: stimulation + exercise group (EG - will perform a Pilates based exercise protocol combined with transcranial direct current stimulation) and sham stimulation + exercise group (SG - will perform the same exercise program combined with sham stimulation). The interventions, regardless of the group, will be carried out three times a week for four weeks. Participants will be submitted to three assessments: the first (T0) will be performed before the treatment protocols; the second (T1) will be performed after the four weeks of intervention; and the third (T2) will be a follow-up one month after the end of the treatment protocol. Pain sensation, functional performance, central sensitization, quality of life, pressure pain threshold, global impression of change, adverse events and medication use will be evaluated. For the statistical analysis, a mixed model ANOVA will be performed for the inter and intragroup comparison, with Tukey's post hoc, considering a significance level of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation + exercise group | Experimental | Device: Transcranial direct current stimulation30-minute exercise program (based on Pilates method) combined with active transcranial direct current stimulation. |
| Sham stimulation + exercise group | Sham comparator | Device: Sham Transcranial direct current stimulationThis arm will perform the same procedures of experimental group but the stimulator will be turned off after 30 seconds and the volunteers will not receive current for the rest of the session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women with chronic nonspecific low back pain (for more than 12 weeks) and minimum pain intensity of 3 on numerical pain rating scale.
Key exclusion criteria (8 listed)
- diagnosis of fracture and spine pathologies, fibromyalgia, spine surgery in the last year;
- low cognitive level assessed by the Mini Mental State Examination;
- presence of central neurological diseases (such as Parkinson's and stroke) or psychiatric (such as depression or schizophrenia);
- history of epileptic illness;
- seizure history;
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 |
|---|---|---|
| Transcranial direct current stimulationExercise protocol + application of active direct current stimulation for 30 minutes. | Device | Stimulation + exercise group |
| Sham Transcranial direct current stimulationExercise protocol + application of simulation of direct current stimulation for 30 minutes. The stimulator will be turned off after 30 seconds and the volunteers will not receive current for the rest of the session. | Device | Sham stimulation + exercise group |
Primary outcome
Pain intensity
Time frame: Change from baseline in pain intensity at four weeks after intervention and 1 month of follow-up
Pain intensity measured by numerical pain rating scale (11 points scale)
Functional performance associated to back pain
Time frame: Change from baseline in functional performance at four weeks after intervention and 1 month of follow-up
Functional performance associated with low back pain measured by Roland Morris Disability Questionnaire (24 itens)
6 secondary outcomes
Pressure pain threshold
Time frame: Change from baseline in pressure pain threshold at four weeks after intervention and 1 month of follow-up
Individual quality of life
Time frame: Change from baseline in quality of life questionnaires at four weeks after intervention and 1 month of follow-up
Patient global impression of change
Time frame: Change from baseline in Patient global impression of change at each intervention day and at four weeks of intervention and 1 month of follow-up.
Central Sensitization
Time frame: Change from baseline of central sensitization at four weeks after intervention and 1 month of follow-up.
Adverse events
Time frame: Up to 4 weeks of intervention and 1 month of follow-up.
Use of medications
Time frame: Up to 4 weeks of intervention and 1 month of follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 38159941da Silva AAC, Gomes SRA, do Nascimento RM, Fonseca AK, Pegado R, Souza CG, Macedo LB. Effects of transcranial direct current stimulation combined with Pilates-based exercises in the treatment of chronic low back pain in outpatient rehabilitation service in Brazil: double-blind randomised controlled trial protocol. BMJ Open. 2023 Dec 30;13(12):e075373. doi: 10.1136/bmjopen-2023-075373.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Low Back Pain and Transcranial Direct Current Stimulation, run by Universidade Federal do Rio Grande do Norte.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liane B Macedo, PhD (+55 (84) 3342-2287, liane.macedo@ufrn.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Change from baseline in pain intensity at four weeks after intervention and 1 month of follow-up). The study lists 2 primary outcomes in all. 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 NCT05467566, 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 20 Jul 2022.