Using electrical stimulation to enhance shoulder strengthening for pain relief
Effectiveness of Transcranial Electrical Stimulation in the Functional Recovery of Subjects with Subacromial Pain Syndrome: Randomized Clinical Trial.
This study is testing if combining shoulder strengthening exercises with a special type of electrical stimulation can help people with shoulder pain feel better and improve their movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Valencia Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT05951933 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a physiotherapy protocol that combines strengthening exercises for the shoulder girdle muscles with anodal transcranial electrical stimulation (a-TES) in patients suffering from subacromial pain syndrome. Participants will undergo a total of 24 sessions, with assessments conducted before, immediately after, and three weeks post-intervention to measure improvements in functionality, quality of life, pain levels, muscle strength, active range of movement, proprioception, posture, and kinematics. The study employs a triple-blind design to ensure unbiased results, and adverse effects will be monitored throughout the intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 65 with unilateral shoulder pain lasting at least three months and specific positive clinical tests indicating subacromial pain syndrome.
Not a fit: Patients with a history of shoulder or neck surgery, fractures, dislocations, or specific shoulder pathologies like osteoarthritis or adhesive capsulitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and functional outcomes for patients with subacromial pain syndrome.
How similar studies have performed: While the combination of strengthening exercises and a-TES is a novel approach, similar studies have shown promise in using electrical stimulation for pain management.
Eligibility criteria
Show full inclusion / exclusion criteria
Subjects will be evaluated during a first consultation by a physiotherapist with experience in shoulder musculoskeletal pathology, following the algorithm for the diagnosis of shoulder problems, recommended by the British Elbow \& Shoulder Society with the aim of detecting possible "flags red" and as a guide to rule out other shoulder pathologies that do not fit into the SDS. However, other tests will be added to ensure diagnostic accuracy, and these are described below.
Inclusion Criteria:
1. Age between 18 and 65 years.
2. Duration of pain greater than or equal to 3 months.
3. 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
Exclusion Criteria:
1. Previous shoulder or neck surgery.
2. History of shoulder fracture or dislocation.
3. Medical diagnosis of shoulder osteoarthritis.
4. Adhesive capsulitis
5. Cervicobrachialgia or reproducible shoulder pain with neck movements.
6. Clinical signs of total tear of the rotator cuff.
7. Corticosteroid injection in the previous 6 weeks.
8. Inflammatory disease, autoimmune or rheumatic, systemic (arthritis, lupus, myopathies).
9. 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).
10. Any neurological or neoplastic disease.
11. 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).
Where this trial is running
Valencia, Valencia
- University of Valencia — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Marta Aguilar-Rodríguez
- Email: Marta.Aguilar@uv.es
- Phone: 607190875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.