Transcranial Electrical Stimulation in Subacromial Pain Syndrome

NCT05951933 | Recruiting

• 1 other identifier: UnVa
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to analyze whether a physiotherapy protocol based on strengthening exercises to the shoulder girdle muscles carried on during anodal transcranial electrical stimulation (a-TES) is more effective on the symptoms and functionality of subjects with subacromial pain syndrome than an isolated strengthening program. The main questions it aims to answer are:

• Is the strengthening + a-TES protocol effective on functionality?
• Is the strengthening + a-TES protocol effective on quality of life?
• Is the strengthening + a-TES protocol effective on pain?
• Is the strengthening + a-TES protocol effective on muscle strength?
• Is the strengthening + a-TES protocol effective on active range of movement?
• Is the strengthening + a-TES protocol effective on proprioception?
• Is the strengthening + a-TES protocol effective on posture?
• Is the strengthening + a-TES protocol effective on glenohumeral and scapulothoracic kinematics? Participants will perform an 8 weeks-3 days/week shoulder strengthening protocol for the rotator cuff and scapulothoracic muscles using elastic bands and dumbbells. The rotator cuff exercises will be performed while they receive a-TES using a neoprene helmet with the electrodes placed in the opposite hemisphere to the affected side. The scapulothoracic exercises will be performed without the transcranial stimulation. The experimental group will receive real a-TES, and will be compared with a control group that will perform the same therapeutic exercises but with placebo a-TES to see the effectiveness of the a-TES on the outcomes cited above.

Conditions

Subacromial Pain Syndrome

Keywords

Physiotherapy; Strenghtening; Conservative treatment; Transcranial direct electrical stimulation; Therapeutic exercise; Pain; Functionality; Quality of life; Mucle Strenght; Range of movement; Proprioception; Posture; Glenohumeral and scapulothoracic kinematics; Long term effects

Outcome Measures

Primary Outcomes (4)

• Changes in Pain and disability Index (SPADI), spanish version, scale.

  Scale for the measurement of Pain and disability related to shoulder disfunction. It contains 13 items, each with a score on a numerical scale from 0 (best) to 10 (worst). It consists of two domains: pain (of 5 items, score between 0-50) and disability (of 8 items, score between 0-80). In each domain the score can be expressed as a percentage. The total score of the scale is obtained as the sum of both domains (0 -100%). A higher score indicates greater pain-related disability.

  Before the intervention, inmediately post intervention (and three months follow up.

• Changes in Western Ontario Rotator cuff (WORC), spanish version, scale.

  Scale for the measurement of the Quality of life related to shoulder disfunction. It consists of 21 questions, each with a visual analogue scale type response. The questions are grouped into 5 domains or sections: physical symptoms (6 items), sports and recreation (4 items), work (4 items), lifestyle (4 items) and emotions (3 items). Each item is measured on a 100 mm scale (from 0 best to 100 worst). So the worst value is 2100 and the best is 0.

  Before the intervention, inmediately post intervention (at eight weeks) and three months follow up.

• Changes in a Visual Analogic scale, for the measurement of the shoulder intensity of pain

  The intensity of the pain experienced in the affected shoulder at rest, at night and during activity in the last week will be evaluated. For this, a visual analogue scale (VAS) will be used. Subjects will mark pain intensity on a continuous horizontal line 10 cm long, labeled on the left end as "no pain" and on the right as "maximal pain".

  Before the intervention, inmediately post intervention (at eight weeks) and three months follow up.

• Changes in shoulder pain pressure threshold (PPT) in Kg.

  Mechanical sensitivity will be assessed using the Pressure Pain Threshold (PPT), which is defined as the minimum pressure at which the sensation of pressure changes to pain. The PPT will be measured with an analog algometer applied perpendicularly to the skin. The PPT will be evaluated on the affected side on: supraspinatus, infraspinatus, upper trapezius, levator scapulae, middle deltoid, C5-C6 interapophyseal joint and tibialis anterior. Higher PPT values (in Kg) will be interpreted as an improvement in mechanical sensitivity to pain in the tested areas.

  Before the intervention, inmediately post intervention (at eight weeks) and three months follow up.

Secondary Outcomes (9)

• Changes in shoulder Muscle strenght measured by a dinamometer (Kg)

  Before the intervention, inmediately post intervention (at eight weeks) and three months follow up.

• Changes in shoulder Active range of movement measured by goniometry (degrees)

  Before the intervention, inmediately post intervention (at eight weeks) and three months follow up.

• Changes in Joint Position sense measured by the laser-pointer assisted angle reproduction (LP-ART), test (degrees).

  Before the intervention, inmediately post intervention (at eight weeks) and three months follow up.

• Changes in head forward posture, shoulder protraction and kiphosis (degrees)

  Before the intervention, inmediately post intervention (at eight weeks) and three months follow up.

• Changes in Subacromial space width measured by ultrasound (milimeters)

  Before the intervention, inmediately post intervention (at eight weeks) and three months follow up.

Study Arms (2)

Strenghtening + a-TES real

EXPERIMENTAL

Protocol of therapeutic exercises + real transcranial electrical stimulation of 8 weeks duration (24 supervised sessions). The program will consist of exercises to strengthen the RM and the scapulothoracic muscles, but the EG will perform the RM strengthening exercises while receiving real a-tDCS.

Other: Strenghtening + TES

Strenghtening + a-TES placebo

SHAM COMPARATOR

Protocol of therapeutic exercises + placebo transcranial electrical stimulation of 8 weeks duration (24 supervised sessions). The program will consist of exercises to strengthen the RM and the scapulothoracic muscles, but the CG will perform the RM strengthening exercises while receiving placebo a-tDCS.

Other: Strenghtening + TES

Interventions

Strenghtening + TES OTHER

Strenghtening of rotator cuff and scapulothoracic muscles protocol with the incorporation of anodal transcranial direct stimulation (real if experimental or sham if control)

Strenghtening + a-TES placebo; Strenghtening + a-TES real

Eligibility Criteria

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

You may qualify if:

• Age between 18 and 65 years.
• Duration of pain greater than or equal to 3 months.
• Presence of 3 or more of the following positive clinical tests:
• painful arc
• External rotation test against isometric resistance
• Neer's test
• Jobe test or empty can test
• Hawkins-Kennedy test

You may not qualify if:

• Previous shoulder or neck surgery.
• History of shoulder fracture or dislocation.
• Medical diagnosis of shoulder osteoarthritis.
• Adhesive capsulitis
• Cervicobrachialgia or reproducible shoulder pain with neck movements.
• Clinical signs of total tear of the rotator cuff.
• Corticosteroid injection in the previous 6 weeks.
• Inflammatory disease, autoimmune or rheumatic, systemic (arthritis, lupus, myopathies).
• Cognitive or behavioral problems that make it impossible to understand and follow the intervention (score less than 24 on the Mini-Mental State Examination Score) (73).
• Any neurological or neoplastic disease.
• Also those who present contraindications for transcranial electrical stimulation. For this, the recommendations of the checklist of Thair et al. which includes:
• personal and family history of epilepsy
• metal implants in the head
• implanted medication pump
• pacemaker

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

TES

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Marta Aguilar-Rodríguez

CONTACT

607190875; Marta.Aguilar@uv.es

Marta Ingles

CONTACT

686320380; marta.ingles@uv.es

Study Design

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

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 19, 2023
• Study Start: November 23, 2023
• Primary Completion: November 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)