Low Back PainNCT05651763
Transcranial Direct Current Stimulation Associated With Pilates in Low Back Pain
A study testing Stimulation and exercise group in people with Low Back Pain and Transcranial Direct Current Stimulation, run by Universidade Federal do Rio Grande do Norte.
Trial summary
This is a randomized and blind clinical trial, whose objective is to evaluate the effects of transcranial stimulation by direct current associated with exercises based on the pilates method on the performance of patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Low Back Pain, Transcranial Direct Current Stimulation
- What is being tested?
- Stimulation and exercise group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Associated With Pilates Based Exercise in Performance of Patients With Chronic Low Back Pain
This is a randomized and blind clinical trial, whose objective is to evaluate the effects of transcranial stimulation by direct current associated with exercises based on the pilates method on the performance of patients with chronic low back pain.
Read the detailed description
Considered a public health problem, low back pain is globally presented as a symptomatology of high prevalence, incidence and recurrence. In addition, it is responsible for a large part of disabilities, reduced functional performance, absences from work and impaired quality of life, which brings biopsychosocial impacts to the affected subjects. 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 associated with Pilates based exercise on chronic low back pain. This is a randomized clinical trial that will be composed of 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, performance, pressure pain threshold, 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
- Stimulation and exercise group, Exercise and sham stimulation group
- Keywords
- Transcranial Direct Current Stimulation, Low back pain, Exercises, Chronic pain, Performance, Treatment
- 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.
Stimulation and exercise groupOther
Exercise protocol + application of active direct current stimulation for 30 minutes.
Exercise and sham stimulation groupOther
Sham Transcranial direct current stimulation 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 and exercise group | Experimental | 30-minute exercise program (based on Pilates method) associated with active transcranial direct current stimulation. Receives: Other: Stimulation and exercise group |
| Exercise and sham stimulation group | Sham comparator | 30-minute exercise program (based on Pilates method) associated with sham transcranial direct current stimulation. Receives: Other: Exercise and sham stimulation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (numerical pain rating scale)
Pain intensity measured by numerical pain rating scale, measured on an 11-point where 0=no pain and 10=worst possible pain.
Measured: up to 1 month of follow-up
Secondary outcomes (4)
Pressure pain threshold
Pressure pain threshold measured by pressure algometer.
Measured: A pressure pain four weeks after intervention and 1 month of follow-up
Root Mean Square (RMS)
Analyze of the electromyographic activity of the back muscles
Measured: Evaluation of RMS four weeks after intervention and 1 month of follow-up
Peak of muscular torque
Evaluate the peak of muscular torque using the hand-held dynamometer.
Measured: Evaluation of Peak of muscular torque four weeks after intervention and 1 month of follow-up
Back muscle fatigue
Measure the back muscular resistance to fatigue using the Ito test
Measured: Evaluation of Back muscle fatigue four weeks after 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 posted15 Dec 2022
- Study startJan 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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, Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651763
- Sponsor's protocol ID
- SRAG2022
- Status last verified
- Dec 2022
- First submitted
- 6 Dec 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcranial Direct Current Stimulation Associated With Pilates Based Exercise in Performance of Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05651763
- Acronym / sponsor ID
- SRAG2022
- Keywords
- Transcranial Direct Current Stimulation, Low back pain, Exercises, Chronic pain, Performance, Treatment
- 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
- Jan 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Dec 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.
This is a randomized and blind clinical trial, whose objective is to evaluate the effects of transcranial stimulation by direct current associated with exercises based on the pilates method on the performance of patients with chronic low back pain.
Detailed description
Considered a public health problem, low back pain is globally presented as a symptomatology of high prevalence, incidence and recurrence. In addition, it is responsible for a large part of disabilities, reduced functional performance, absences from work and impaired quality of life, which brings biopsychosocial impacts to the affected subjects. 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 associated with Pilates based exercise on chronic low back pain. This is a randomized clinical trial that will be composed of 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, performance, pressure pain threshold, 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 and exercise group | Experimental | Other: Stimulation and exercise group30-minute exercise program (based on Pilates method) associated with active transcranial direct current stimulation. |
| Exercise and sham stimulation group | Sham comparator | Other: Exercise and sham stimulation group30-minute exercise program (based on Pilates method) associated with sham transcranial direct current stimulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 |
|---|---|---|
| Stimulation and exercise groupExercise protocol + application of active direct current stimulation for 30 minutes. | Other | Stimulation and exercise group |
| Exercise and sham stimulation groupSham Transcranial direct current stimulation 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. | Other | Exercise and sham stimulation group |
Primary outcome
Pain intensity (numerical pain rating scale)
Time frame: up to 1 month of follow-up
Pain intensity measured by numerical pain rating scale, measured on an 11-point where 0=no pain and 10=worst possible pain.
4 secondary outcomes
Pressure pain threshold
Time frame: A pressure pain four weeks after intervention and 1 month of follow-up
Root Mean Square (RMS)
Time frame: Evaluation of RMS four weeks after intervention and 1 month of follow-up
Peak of muscular torque
Time frame: Evaluation of Peak of muscular torque four weeks after intervention and 1 month of follow-up
Back muscle fatigue
Time frame: Evaluation of Back muscle fatigue four weeks after 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 15 Dec 2022.
- 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 Stimulation and exercise group 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 15 Dec 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 Jamilson S Brasileiro, PhD (+55 84 3342-2008, brasileiro@ufrnet.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (numerical pain rating scale) (time frame: up to 1 month of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2022.