Effects of Percutaneous Electrical Stimulation in Patients With Chronic Supraspinatus Tendinopathy

Sponsored by Universidad Miguel Hernandez de Elche

About this trial

Last updated 2 months ago

Study ID

JVT004

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 65 Years

All Sexes

Trial Timing

Starts in 3 months

What is this trial about?

The aim of this clinical trial is to evaluate the effects of two percutaneous stimulation techniques-Percutaneous Electrical Stimulation (PENS) and Percutaneous Electrolysis (PE)-combined with a therapeutic exercise (TE) program for the shoulder joint complex, on pain and function in individuals with chronic supraspinatus tendinopathy. The main question this study seeks to answer is: Would incorporating percutaneous electrical stimulation (PENS) of the axillary and suprascapular nerves and galvanic percutaneous stimulation (PE) of the supraspinatus tendon into a therapeutic exercise (TE) program for the shoulder joint complex improve therapeutic outcomes in terms of pain, function, and upper limb disability? Based on an exercise program in all groups, researchers will compare the efficacy of active PENS and PE, as well as placebo, in all their combinations. Participants will undergo a 12-week exercise program, during which they will receive four sessions (one session per week) of active percutaneous electrical stimulation or a placebo during the first month. Participants will: * Visit the center on four separate occasions for results measurement. * Keep a session log to verify adherence to the exercise program.

What are the participation requirements?

Inclusion Criteria

* Subjects attending the shoulder unit of the traumatology and orthopedic surgery service at Clínica HLA Vistahermosa (TraumaVist) who are clinically diagnosed with supraspinatus tendinopathy (M75.1 Rotator cuff tendinopathy - ICD-10), according to the following criteria (Desmeules et al., 2025).

* Participants of both sexes, aged between 18 and 65 years, diagnosed with chronic supraspinatus tendinopathy, or any of the related terms, provided they also meet the conditions detailed below.

* Painful symptoms associated with the insertion area of the supraspinatus tendon, present for at least 3 months, of non-traumatic origin, which increase with palpation (score equal to or greater than 3/10 on a numerical pain scale) and with resisted movements, and not associated with signs of nerve root irritation.

* Structural changes in the supraspinatus tendon (tendinosis), observed via ultrasound or MRI, and confirmed by a specialist physician.

* Positive results in at least 2 of the 5 assessment tests: Hawkins-Kennedy, Neer, Jobe, painful arc of motion, and resisted external rotation.

* Attend the center, referred by a specialist in traumatology and orthopedics, with a prescription for physiotherapy treatment.

Exclusion Criteria

* Individuals with any of the following circumstances will be excluded:

* Intratendinous calcification in the supraspinatus muscle.

* Partial or complete tear of any rotator cuff structure.

* Serious illnesses, diabetes, or systemic inflammatory disease.

* Pregnant women (at any stage of pregnancy).

* Presence of concomitant pathology in the affected shoulder joint complex at the time of recruitment (previous trauma, capsulitis, fracture and dislocation, history of surgery, entrapment neuropathies, among others).

* Regular analgesic or anti-inflammatory pharmacological treatment, including corticosteroid injections in the area, within the 6 months prior to recruitment.

* Difficulty understanding and following the intervention program, in any of its modalities (percutaneous electrical stimulation and exercises). • Individuals with belonephobia (fear of needles), or a contraindication for the application of either percutaneous electrical stimulation technique (EP or PENS).

* High scores on the Tampa - TSK-11 kinesiophobia scale (≥36 points).