Effects of Percutaneous Electrical Stimulation in Patients With Chronic Supraspinatus Tendinopathy

NCT07498569 | Not Yet Recruiting

• 1 other identifier: JVT004
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Supraspinatus Tendinopathy

Keywords

Chronic pain; Shoulder tendinopathy; Percutaneous Electrolysis; Percutaneous Electrical Nerve Stimulation; Therapeutic exercise

Outcome Measures

Primary Outcomes (4)

• Pain Intensity

  The Numerical Pain Rating Scale (NPRS) will be used to estimate pain intensity. This scale assigns a number between 0 (no pain) and 10 (worst possible pain) (Farrar et al., 2001). Using this instrument, the patient will rate the intensity of the pain they feel at the worst time of day and the average level of pain experienced over the past week. This easy-to-complete, quick, and simple scale has shown a Minimal Detectable Change (MDC) of 1.3 to 2.8 points in patients with musculoskeletal problems and 1.7 points in subacromial pain syndrome.

  - Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3)

• Pressure Pain Threshold (PPT)

  The test will be performed using a mechanical pressure algometer at specific study points to determine the amount of pressure applied at which the sensation of pressure changes to pain. The patient will be seated in a comfortable and relaxed position. The procedure consists of applying the tip of the algometer perpendicular to the skin and maintaining a pressure that will be progressively increased until the pain threshold is reached. Subjects will be instructed to signal when this pressure pain threshold (PPT) is exceeded. The physiotherapist will take three measurements, with a 30-second rest period between each measurement, calculating the average value in kg.. Measurements will be taken on the affected side, in the subacromial space region (treatment area), in the upper trapezius muscle (midpoint between the neck and shoulder muscle fibers), in the ventral part of the middle head of the deltoid muscle (segmental area), and in the tibialis anterior muscle,

  - Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3)

• Function

  The Constat-Murley (CM) questionnaire is a commonly used, specific instrument for assessing overall shoulder joint function (Roy et al., 2010). The maximum score is 100 points, with 90 to 100 considered excellent, 80 to 89 good, 70 to 79 fair, and below 70 poor, although scores may vary with age. This tool includes a subjective assessment of the patient's pain and ability to perform daily activities (35 points), and an objective assessment of mobility and strength through physical examination (65 points). Its use has been specifically validated in shoulder arthroplasty, rotator cuff repair, adhesive capsulitis, and proximal humerus fractures. This tool has shown a Minimal Detectable Change (MDC) of 11.6 points in patients with subacromial impingement.

  - Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3)

• Disability

  The Shoulder Pain and Disability Index (SPADI) focuses on the degree of pain or disability caused by shoulder problems during the past week. It is a self-administered questionnaire consisting of two dimensions: one for pain and one for functional activities. The pain dimension comprises five questions about the severity of pain. Functional activities are assessed with eight questions, designed to measure the degree of difficulty a person has performing various activities of daily living that require the use of the upper extremities. The patient answers the questions using a visual analog scale (from 0 to 10), both in the pain dimension (0 equals no pain and 10 equals the worst pain imaginable) and in the disability dimension (0 equals no difficulty and 10 equals so difficult that help was required). In patients with subacromial pain syndrome, this questionnaire has shown a Minimal Detectable Change (MDC) of 20.5 points.

  - Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3)

Secondary Outcomes (4)

• Overall Perception of Clinical Change

  - Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3)

• Kinesiophobia

  - Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3)

• Perceived self-efficacy with pain

  - Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3)

• Adherence to the exercise program

  - Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3)

Study Arms (4)

Intervention group 1 (EP + PENS + ET)

EXPERIMENTAL

Percutaneous Electrolysis (EP) + Percutaneous Electrical Nerve Stimulation (PENS) + Therapeutic Exercise (ET)

Procedure: EP + PENS + ET

Intervention group 2 (EP + PENS placebo + ET)

ACTIVE COMPARATOR

Percutaneous Electrolysis (PE) + Percutaneous Electrical Nerve Stimulation (PENS - placebo) + Therapeutic Exercise (ET)

Procedure: EP + PENS placebo + ET

Intervention group 3 (EP placebo + PENS + ET)

ACTIVE COMPARATOR

Percutaneous Electrolysis (EP - placebo) + Percutaneous Electrical Nerve Stimulation (PENS) + Therapeutic Exercise (ET)

Procedure: EP placebo + PENS + ET

Control group (EP placebo + PENS placebo + ET)

ACTIVE COMPARATOR

Percutaneous Electrolysis (EP - placebo) + Percutaneous Electrical Nerve Stimulation (PENS - placebo) + Therapeutic Exercise (ET)

Procedure: EP placebo + PENS placebo + ET

Interventions

EP + PENS + ET PROCEDURE

Percutaneous Electrolysis (EP) + Percutaneous Electrical Nerve Stimulation (PENS) + Therapeutic Exercise (ET)

Intervention group 1 (EP + PENS + ET)

EP + PENS placebo + ET PROCEDURE

Percutaneous Electrolysis (PE) + Percutaneous Electrical Nerve Stimulation (PENS - placebo) + Therapeutic Exercise (ET)

Intervention group 2 (EP + PENS placebo + ET)

EP placebo + PENS + ET PROCEDURE

Percutaneous Electrolysis (EP - placebo) + Percutaneous Electrical Nerve Stimulation (PENS) + Therapeutic Exercise (ET)

Intervention group 3 (EP placebo + PENS + ET)

EP placebo + PENS placebo + ET PROCEDURE

Percutaneous Electrolysis (EP - placebo) + Percutaneous Electrical Nerve Stimulation (PENS - placebo) + Therapeutic Exercise (ET)

Control group (EP placebo + PENS placebo + ET)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Study Sites (1)

Centro de Fisioterapia VToledo.

San Vicent del Raspeig, Alicante, 03690, Spain

Location

Related Publications (9)

• Augustyn D, Paez A. The effectiveness of intratissue percutaneous electrolysis for the treatment of tendinopathy: a systematic review. S Afr J Sports Med. 2022 Jan 1;34(1):v34i1a12754. doi: 10.17159/2078-516X/2022/v34i1a12754. eCollection 2022.

  PMID: 36815929 BACKGROUND

• Arulkumar S,Neuchat EE,Ly E,Ly AI,Fahimipour K,Desai MJ

  BACKGROUND

• Arias-Buría JL,Truyols-Domínguez S,Valero-Alcaide R,Salom-Moreno J,Atín-Arratibel MA,Fernández-de-Las-Peñas C

  BACKGROUND

• Arias-Buria JL, Cleland JA, El Bachiri YR, Plaza-Manzano G, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrical Nerve Stimulation of the Radial Nerve for a Patient With Lateral Elbow Pain: A Case Report With a 2-Year Follow-up. J Orthop Sports Phys Ther. 2019 May;49(5):347-354. doi: 10.2519/jospt.2019.8570. Epub 2019 Jan 18.

  PMID: 30658050 BACKGROUND

• Albright-Trainer B, Phan T, Trainer RJ, Crosby ND, Murphy DP, Disalvo P, Amendola M, Lester DD. Peripheral nerve stimulation for the management of acute and subacute post-amputation pain: a randomized, controlled feasibility trial. Pain Manag. 2022 Apr;12(3):357-369. doi: 10.2217/pmt-2021-0087. Epub 2021 Nov 11.

  PMID: 34761694 BACKGROUND

• Albert-Lucena D, Navarro-Santana MJ, Lopez-de-Uralde-Villanueva I, Diaz-Arribas MJ, Valera-Calero JA, Fernandez-de-Las-Penas C, Plaza-Manzano G. Immediate effects of percutaneous electrical nerve stimulation in patients with lateral elbow pain. Physiother Theory Pract. 2024 Dec;40(12):2783-2794. doi: 10.1080/09593985.2023.2296063. Epub 2023 Dec 26.

  PMID: 38146921 BACKGROUND

• Abat F, Valles SL, Gelber PE, Polidori F, Stitik TP, Garcia-Herreros S, Monllau JC, Sanchez-Ibanez JM. [Molecular repair mechanisms using the Intratissue Percutaneous Electrolysis technique in patellar tendonitis]. Rev Esp Cir Ortop Traumatol. 2014 Jul-Aug;58(4):201-5. doi: 10.1016/j.recot.2014.01.002. Epub 2014 May 10. Spanish.

  PMID: 24821478 BACKGROUND

• Abat F,Sánchez-Sánchez JL,Martín-Nogueras AM,Calvo-Arenillas JI,Yajeya J,Méndez-Sánchez R,Monllau JC,Gelber PE

  BACKGROUND

• Abat F,Diesel WJ,Gelber PE,Polidori F,Monllau JC,Sanchez-Ibañez JM

  BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• José-Vicente Toledo-Marhuenda, Ph D

  Miguel Hernández University. Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José-Vicente Toledo-Marhuenda, Ph D

CONTACT

+0034 965919260; josetoledo@umh.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Researcher 1 - blinded to the treatment. Responsible for receiving the patient and verifying that they meet the inclusion criteria in order to offer them participation in the study. Researcher 2 - blinded to the treatment. Responsible for conducting the assessments. Researchers 3, 4, and 5 - Perform the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)