Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-01 @ 10:36 PM
Study NCT ID:
NCT05951933
Status:
RECRUITING
Last Update Posted:
2025-03-30
First Post:
2023-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Electrical Stimulation in Subacromial Pain Syndrome
Sponsor:
University of Valencia
Organization:
Study Overview
Official Title:
Effectiveness of Transcranial Electrical Stimulation in the Functional Recovery of Subjects with Subacromial Pain Syndrome: Randomized Clinical Trial.
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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. .
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. .
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: