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Subacromial Pain SyndromeNCT05951933

Transcranial Electrical Stimulation in Subacromial Pain Syndrome

A study testing Strenghtening + TES in people with Subacromial Pain Syndrome, run by University of Valencia at 1 site in Spain.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Subacromial Pain Syndrome
What is being tested?
Strenghtening + TES
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteSpain
Study dates
23 Jan 2023to Feb 2025
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

  • 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

Who cannot join

  • 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.
Show all 22Show fewer
  • 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
  • recurring headaches
  • skin diseases of the scalp (psoriasis, eczema)
  • head injuries
  • serious head surgeries
  • pregnancy
  • heart diseases
  • medications (psychotropics or antihistamines).

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • University of Valencia

    Valencia, Valencia, 46010

Other trials in Spain

About this study

Official title: Effectiveness of Transcranial Electrical Stimulation in the Functional Recovery of Subjects With Subacromial Pain Syndrome: Randomized Clinical Trial.

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:

Read more
  • 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.

Read the detailed description

The project has obtained the approval of the Ethics Committee of the University of Valencia on June 6, 2023 (Id: UV-INV_ETICA-2701990).

The intervention will take place in the laboratories of the Physiotherapy Department of the University of Valencia. All the participants, once they have signed the informed consent and, after being randomly assigned to the EG or the CG, will be evaluated before starting the treatment (T0). A post-intervention evaluation will be carried one day after the end of the 24 sessions (T1), and a follow-up evaluation 3 weeks after the intervention (T2).

Subjects with unilateral shoulder pain will be recruited through social media and posters posted in primary care centers, hospitals, and other related locations.

The study will be triple blind: participants, evaluators and therapists. In order to monitor the possible adverse effects derived from the application of a-TES, the Bruitoni et al. Adverse Effects Questionnaire will be completed in each session. It is a questionnaire that contains 10 possible side effects (headache, neck pain, scalp pain, tingling, itching, burning, redness of the skin, drowsiness, concentration problems, severe mood change).If any of these symptoms occurred, the stimulation would be stopped and the next day would be tried again. If these effects were repeated, especially the headache or were of severe intensity, the patient would be withdrawn from the investigation.

The sample size has been calculated with the formula: n = (2 * (Zα/2 + Zβ) / d) ² (significance level of 0.05, Zα/2 = 1.96; Zβ =0.84, d= 0.5). Total, n= 64 subjects. In addition, the sample may be increased by 15% in anticipation of possible losses throughout the study (= 10 more subjects). Classic statistical methods will be used to calculate the mean as a measure of central tendency and the standard deviation as a measure of dispersion. Before carrying out the inferential analysis, the normal distribution of the sample will be checked using the Shapiro-Wilk test, homoscedasticity using the Levene test, and sphericity using the Mauchly test. Regarding the inferential analysis, a mixed ANOVA will be used with an intra-subject factor (time), with 4 categories, corresponding to the assessments made; and a between-subjects (group) factor corresponding to the assigned intervention. For post hoc comparisons, the Bonferroni adjustment will be used. In the event that the assumptions are not met, the corresponding non-parametric tests will be applied: Wilcoxon and Mann Whitney, adjusting the type I error. In the event of losses, the intention-to-treat procedure will be used for the statistical analysis of the data. .

Being tested
Strenghtening + TES
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
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Strenghtening + TESOther

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

Study groups in NCT05951933
Study groupRoleWhat they receive
Strenghtening + a-TES realExperimentalProtocol 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.
Receives: Other: Strenghtening + TES
Strenghtening + a-TES placeboSham comparatorProtocol 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.
Receives: Other: Strenghtening + TES

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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".

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

  4. 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.

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

Secondary outcomes (9)
  1. Changes in shoulder Muscle strenght measured by a dinamometer (Kg)

    Shoulder strength will be quantified with a digital hand dynamometer for internal and external rotation, abduction, horizontal abduction, and scapular protraction on the affected side.

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

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

    A universal goniometer will be used to measure pain-free active range of motion of the affected shoulder for flexión, abduction and rotations.

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

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

    A target with a central dot, drawn on a 1 x 1 m grid paper, will be placed 1 meter away the patient. The center of the target will be adjusted to the height of each participant and leveled horizontally to align with the glenohumeral joint, at the point where the assessor confirms 90° shoulder flexion-abduction using a goniometer.The evaluator will note the distance between both points (the target point and the point reached by the patient, in flexion and abduction) and the X and Y coordinates of the position reached with the pointer, in cm. With these data you will obtain the angular deviation of the target position

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

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

    For the head forward and shoulder protraction measurement, the participants will remain standing comfortably with their backs uncovered. Next, a photo of the cervicothoracic region will be taken with a digital camera. From the image, the angles will be measured, using ImageJ image measurement software.To measure dorsal kyphosis, two bubble inclinometers will be placed, one on T1 and T2 and the other on T12 and L1. The kyphosis angle will be the sum of both.

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

  5. Changes in Subacromial space width measured by ultrasound (milimeters)

    Distance between acromion and humerus head. The images will be captured with the participant seated in a chair, with the arm in three standardized positions: at 0˚, at 45˚ and at 60˚ of active abduction.

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

  6. Changes in the scapulohumeral rithm (i.e., coordinated movement of the glenohumeral joint and the scapulothoracic joint) measured by al inclinometer (degrees).

    The scapula measurement will be made at rest and during movement, at the moment the patient actively reaches the 60˚, 90˚ and 120˚ abduction positions. the glenohumeral-scapulothoracic ratio will be calculated in each position.

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

  7. Changes in the mean signal amplitude of the scapulothoracic muscles measured by a surface electromiograph (µV)

    Muscle activation of the Trapezius superior (TS), Trapezius inferior (TI), and anterior serratus (AS) will be measured at rest, at 60˚, 90˚, and 120˚ glenohumeral abduction. Each position will be held for 5 seconds. The surface electrodes will be placed according to the recommendations of the Surface Electromyography for the Non-Invasive Evaluation of Muscles (SENIAM) The mean signal amplitude (µV) will be calculated during the 5 seconds of muscle activation of the TS, TI and AS at each abduction angle.

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

  8. Changes in the signal frequency of the scapulothoracic muscles measured by a surface electromiograph (Hz)

    Muscle activation of the Trapezius superior (TS), Trapezius inferior (TI), and anterior serratus (AS) will be measured at rest, at 60˚, 90˚, and 120˚ glenohumeral abduction. Each position will be held for 5 seconds. The surface electrodes will be placed according to the recommendations of the Surface Electromyography for the Non-Invasive Evaluation of Muscles (SENIAM) The frequency will be calculated during the 5 seconds of muscle activation of the TS, TI and AS at each abduction angle.

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

  9. Changes in the mean signal amplitud of primary motor cortex (M1) measured by EEG (µV)

    The device (Starstim® tES-EEG systems, Neuroelectrics, Barcelona, Spain) will be used, with electrodes placed on the M1 motor area, connected to a neoprene helmet, to perform the electroencephalographic recording of cortical activity.The amplitude of the EEG peaks will be measured in µV.

    Measured: Before and after each of the 24 sessions.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study start23 Jan 2023 (estimated)
  3. Primary completionFeb 2025 (estimated)
  4. Study completionFeb 2025 (estimated)

Why it stopped: The study was withdrawn before enrollment because the required clinical/research staff availability could not be ensured

Resources

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, Care provider, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05951933
Sponsor's protocol ID
UnVa
Status last verified
Jun 2026
First submitted
29 Jun 2023
Last updated
11 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Strenghtening + TES in people with Subacromial Pain Syndrome, run by University of Valencia at 1 site in Spain.

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 8 inclusion and 22 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: withdrawn, as of the sponsor's last update on 11 Jun 2026. 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 Spain. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Pain and disability Index (SPADI), spanish version, scale. (time frame: Before the intervention, inmediately post intervention (and three months follow up.). The study lists 4 primary outcomes in all. 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 11 Jun 2026.

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