Subacromial Pain SyndromeNCT06229925
Effects of Transcranial Direct Current Stimulation Versus Sham in Subacromial Pain Syndrome
A study testing Experimental Stimulation in people with Subacromial Pain Syndrome and Transcranial Direct Current Stimulation, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
The purpose of this study is to investigate the effects of applying Transcranial direct current stimulation on pain levels and function, quality of life, muscle strength and range of motion in individuals with subacromial pain syndrome. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Subacromial Pain Syndrome, Transcranial Direct Current Stimulation
- What is being tested?
- Experimental Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Mar 2024to 1 Dec 2024
- 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 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral pain in one shoulder
- Pain level ≥ 3 on the Numerical Pain Scale (END), at rest, for at least 3 months
- No previous treatment with tDCS
- Present graded disability on the DASH questionnaire (> 15 points)
- At least three positive tests, among the five indicated below: Neer, Hawkins, Jobe, Patte or painful abduction arch.
Who cannot join
- Indication for surgical repair and/or history of shoulder surgery
- Shoulder fracture and/or dislocation
- Partial or total rupture of one of the rotator cuff tendons and/or the long head of the biceps
- Fibromyalgia
- History of epilepsy
- Panic syndrome
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- Implantable devices in the skull
- Significant neurological or psychiatric diseases
- Severe cardiopulmonary, renal and hepatic diseases
- Current pregnancy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Rio Grande do Norte (UFRN)
Natal, Rio Grande do Norte, 59078-900
Vinícius Dantas, Esp, +55 84 998281674, viniciuus.dantas@gmail.com
About this study
Official title: Effects of Transcranial Direct Current Stimulation Versus Sham in Subacromial Pain Syndrome: A Randomized Controlled Trial
The purpose of this study is to investigate the effects of applying Transcranial direct current stimulation on pain levels and function, quality of life, muscle strength and range of motion in individuals with subacromial pain syndrome.
Read the detailed description
This is a controlled, randomized and blind clinical trial, which will be carried out with individuals from the city of Natal/RN, aged between 18 and 65 years, of both sexes, diagnosed with subacromial pain syndrome, who present a level of pain greater than 3 on the Numerical Pain Scale, at rest, for at least 3 months. The research sample will be non-probabilistic, in which they will be randomly distributed into two distinct groups: active tDCS (active stimulation) and sham tDCS (stimulation turned off after 20 seconds). This research was submitted to the UFRN Research Ethics Committee through the national interface Plataforma Brasil. This research covers the ethical aspects guided by Resolution 466/2012 of the National Health Council and the Declaration of Helsinki for research with human beings. In addition, the research will be registered in Clinical Trials. All data will be recorded in the laboratory's database under confidentiality and may only be processed by the responsible researchers. The study will only begin after the issuance of the reference opinion approving the project. All subjects will be duly informed and guided regarding the scheduled procedures, which will only be carried out after reading, accepting and signing the Informed Consent Form. After approval by the Research Ethics Committee, following resolution 466/2012, a pilot study was carried out to adapt all research procedures, as well as training the researchers involved. Volunteers will be duly informed about the objectives and advantages of their participation in the study, and will then undergo an assessment of pain sensation, using the Numerical Pain Scale; assessment of shoulder range of motion, using the Smartphone clinometer application; assessment of muscle strength through flexion, hyperextension, medial and lateral rotation movements of the shoulder, using a portable dynamometer; will complete the Douleur Neuropathique 4 questionnaire (DN4) to screen for neuropathic pain, the Disabilities of the arm, shoulder and hand questionnaire (DASH) to assess upper limb function, and the Short Form 36 Health Survey questionnaire (SF-36) to assess health-related quality of life. They will then undergo 20 minutes of stimulation for 5 consecutive days, according to the pre-determined group. The assessments will be repeated at the end of the intervention and in a 1-week follow-up, in which they will receive an educational booklet.
- Being tested
- Experimental Stimulation, Sham Stimulation
- Keywords
- Transcranial Direct Current Stimulation, Neuromodulation, Pain in the shoulder, Chronic pain, Treatment
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental StimulationDevice
Application of active direct current stimulation for 20 minutes, at an intensity of 2mA, with 30s of ramp up and ramp down, for 5 consecutive days. The anode will be positioned on M1 (C3) contralateral to the painful shoulder; The reference electrode (cathode) will be placed in the supraorbital region contralateral to the anode (Fp2). Direct current will be delivered through two 35cm2 surface sponge electrodes (7x5) soaked in saline solution, using a portable neuromodulator. During the entire stimulation, volunteers will remain seated in an air-conditioned and quiet place.
Sham StimulationDevice
Application of active direct current stimulation for 20 minutes, at an intensity of 2mA, for 5 consecutive days, administered in the same way as the experimental intervention. However, 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 |
|---|---|---|
| Experimental Stimulation | Experimental | Active direct current stimulation for 20 minutes. Receives: Device: Experimental Stimulation |
| Sham Stimulation | Sham comparator | Sham direct current stimulation for 20 minutes. Receives: Device: Sham Stimulation |
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 week of follow-up
Secondary outcomes (4)
Peak of muscular torque
Evaluate the peak of muscular torque using the hand-held dynamometer.
Measured: Up to 1 week of follow-up
Range of motion (ROM)
Evaluate the range of motion using the Smartphone clinometer application
Measured: Up to 1 week of follow-up
Degree of disability of the upper limbs
Evaluate the degree of disability of the upper limbs using the Disabilities of the arm, shoulder and hand (DASH) questionnaire. Total scores range from 0 to 100 for each dimension, with higher values indicating worse upper limb function.
Measured: Up to 1 week of follow-up
Health-related Quality of Life
Evaluate the health-related Quality of Life using the Quality of Life questionnaire (SF-36). The score for this questionnaire ranges from 0 to 100, with higher values indicating a better general state of health.
Measured: Up to 1 week 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 posted29 Jan 2024
- Study start4 Mar 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Pain SyndromeStudies 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
- 32 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
- Investigators
- Vinícius Dantas, Esp, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229925
- Sponsor's protocol ID
- VDS2024
- Status last verified
- Mar 2024
- First submitted
- 18 Jan 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation Versus Sham in Subacromial Pain Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06229925
- Acronym / sponsor ID
- VDS2024
- Keywords
- Transcranial Direct Current Stimulation, Neuromodulation, Pain in the shoulder, Chronic pain, Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 29 Jan 2024 (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 investigate the effects of applying Transcranial direct current stimulation on pain levels and function, quality of life, muscle strength and range of motion in individuals with subacromial pain syndrome.
Detailed description
This is a controlled, randomized and blind clinical trial, which will be carried out with individuals from the city of Natal/RN, aged between 18 and 65 years, of both sexes, diagnosed with subacromial pain syndrome, who present a level of pain greater than 3 on the Numerical Pain Scale, at rest, for at least 3 months. The research sample will be non-probabilistic, in which they will be randomly distributed into two distinct groups: active tDCS (active stimulation) and sham tDCS (stimulation turned off after 20 seconds). This research was submitted to the UFRN Research Ethics Committee through the national interface Plataforma Brasil. This research covers the ethical aspects guided by Resolution 466/2012 of the National Health Council and the Declaration of Helsinki for research with human beings. In addition, the research will be registered in Clinical Trials. All data will be recorded in the laboratory's database under confidentiality and may only be processed by the responsible researchers. The study will only begin after the issuance of the reference opinion approving the project. All subjects will be duly informed and guided regarding the scheduled procedures, which will only be carried out after reading, accepting and signing the Informed Consent Form. After approval by the Research Ethics Committee, following resolution 466/2012, a pilot study was carried out to adapt all research procedures, as well as training the researchers involved. Volunteers will be duly informed about the objectives and advantages of their participation in the study, and will then undergo an assessment of pain sensation, using the Numerical Pain Scale; assessment of shoulder range of motion, using the Smartphone clinometer application; assessment of muscle strength through flexion, hyperextension, medial and lateral rotation movements of the shoulder, using a portable dynamometer; will complete the Douleur Neuropathique 4 questionnaire (DN4) to screen for neuropathic pain, the Disabilities of the arm, shoulder and hand questionnaire (DASH) to assess upper limb function, and the Short Form 36 Health Survey questionnaire (SF-36) to assess health-related quality of life. They will then undergo 20 minutes of stimulation for 5 consecutive days, according to the pre-determined group. The assessments will be repeated at the end of the intervention and in a 1-week follow-up, in which they will receive an educational booklet.
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 |
|---|---|---|
| Experimental Stimulation | Experimental | Device: Experimental StimulationActive direct current stimulation for 20 minutes. |
| Sham Stimulation | Sham comparator | Device: Sham StimulationSham direct current stimulation for 20 minutes. |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral pain in one shoulder
- Pain level ≥ 3 on the Numerical Pain Scale (END), at rest, for at least 3 months
- No previous treatment with tDCS
- Present graded disability on the DASH questionnaire (> 15 points)
- At least three positive tests, among the five indicated below: Neer, Hawkins, Jobe, Patte or painful abduction arch.
Key exclusion criteria (10 listed)
- Indication for surgical repair and/or history of shoulder surgery
- Shoulder fracture and/or dislocation
- Partial or total rupture of one of the rotator cuff tendons and/or the long head of the biceps
- Fibromyalgia
- History of epilepsy
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 |
|---|---|---|
| Experimental StimulationApplication of active direct current stimulation for 20 minutes, at an intensity of 2mA, with 30s of ramp up and ramp down, for 5 consecutive days. The anode will be positioned on M1 (C3) contralateral to the painful shoulder; The reference electrode (cathode) will be placed in the supraorbital region contralateral to the anode (Fp2). Direct current will be delivered through two 35cm2 surface sponge electrodes (7x5) soaked in saline solution, using a portable neuromodulator. During the entire stimulation, volunteers will remain seated in an air-conditioned and quiet place. | Device | Experimental Stimulation |
| Sham StimulationApplication of active direct current stimulation for 20 minutes, at an intensity of 2mA, for 5 consecutive days, administered in the same way as the experimental intervention. However, 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 |
Primary outcome
Pain intensity (numerical pain rating scale)
Time frame: Up to 1 week 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
Peak of muscular torque
Time frame: Up to 1 week of follow-up
Range of motion (ROM)
Time frame: Up to 1 week of follow-up
Degree of disability of the upper limbs
Time frame: Up to 1 week of follow-up
Health-related Quality of Life
Time frame: Up to 1 week 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 27 Mar 2024.
- 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.
Vinícius Dantas, Esp principal investigator
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Stimulation in people with Subacromial Pain Syndrome and Transcranial Direct Current Stimulation, run by Universidade Federal do Rio Grande do Norte 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 5 inclusion and 10 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 27 Mar 2024. 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.
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 week 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 27 Mar 2024.