Effects of Transcranial Direct Current Stimulation Versus Sham in Subacromial Pain Syndrome

NCT06229925 | Recruiting

• 1 other identifier: VDS2024
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subacromial Pain Syndrome; Transcranial Direct Current Stimulation

Keywords

Transcranial Direct Current Stimulation; Neuromodulation; Pain in the shoulder; Chronic pain; Treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 week of follow-up

Secondary Outcomes (4)

• Peak of muscular torque

  Up to 1 week of follow-up

• Range of motion (ROM)

  Up to 1 week of follow-up

• Degree of disability of the upper limbs

  Up to 1 week of follow-up

• Health-related Quality of Life

  Up to 1 week of follow-up

Study Arms (2)

Experimental Stimulation

EXPERIMENTAL

Active direct current stimulation for 20 minutes.

Device: Experimental Stimulation

Sham Stimulation

SHAM COMPARATOR

Sham direct current stimulation for 20 minutes.

Device: Sham Stimulation

Interventions

Experimental Stimulation DEVICE

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.

Experimental Stimulation

Sham Stimulation DEVICE

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.

Sham Stimulation

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Implantable devices in the skull
• Significant neurological or psychiatric diseases
• Severe cardiopulmonary, renal and hepatic diseases
• Current pregnancy.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Federal University of Rio Grande do Norte (UFRN)

Natal, Rio Grande do Norte, 59078-900, Brazil

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vinícius Dantas, Esp

  Universidade Federal do Rio Grande do Norte

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamilson S Brasileiro, PhD

CONTACT

+55 84 3342-2008; brasileiro@ufrnet.br

Vinícius Dantas, Esp

CONTACT

+55 84 99828-1674; viniciuus.dantas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Researcher

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: March 4, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)