PEMF Therapy in Shoulder Tendinopathy

NCT07550543 | Recruiting

• 1 other identifier: AlexandraCiota
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether pulsed electromagnetic field (PEMF) therapy delivered via the Super Inductive System (SIS), integrated into a multimodal rehabilitation program, improves pain, function, pressure pain threshold, muscle strength, psychological status, and quality of life in adults with shoulder tendinopathies. The main questions it aims to answer are:

• Does the addition of PEMF (SIS) therapy reduce pain intensity and improve pressure pain threshold compared to standard balneophysiotherapy?
• Does PEMF (SIS) therapy improve shoulder function, muscle strength, psychological status, and quality of life? The study will compare a multimodal rehabilitation program supplemented with PEMF (SIS) therapy to standard balneophysiotherapy to determine whether the addition of PEMF (SIS) provides superior clinical outcomes. Participants will:
• Undergo a multimodal rehabilitation program including balneophysiotherapy
• Be assigned to receive either standard treatment or treatment supplemented with PEMF (SIS) therapy
• Be evaluated at baseline (admission), immediately after treatment completion (discharge), and at 4 weeks after treatment using validated clinical instruments assessing pain, function, pressure pain threshold, muscle strength, psychological status, depressive symptoms, and quality of life.

Conditions

Shoulder Tendinopathy

Keywords

Nanopulsed Electromagnetic Field; Pulsed Electromagnetic Field; PEMF; Super Inductive System; Balneotherapy; Physiotherapy; Shoulder Pain; Tendinopathy

Outcome Measures

Primary Outcomes (1)

• Pain intensity assessed by Visual Analog Scale (VAS)

  Pain intensity will be measured using the Visual Analog Scale (VAS). Participants were asked to rate their current pain intensity by marking a point on a 100-mm horizontal line, where 0 indicates "no pain" and 100 indicates "worst pain imaginable." The score was recorded in millimeters (mm). Outcome range and interpretation: Minimum value: 0; Maximum value: 100. Higher scores indicate worse pain intensity.

  Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.

Secondary Outcomes (7)

• Shoulder function assessed by Shoulder Pain and Disability Index (SPADI)

  Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.

• Pressure Pain Threshold (PPT) assessed by digital algometry

  Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.

• Range of motion (ROM) assessed by goniometry

  Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.

• Muscle strength assessed by dynamometry

  Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.

• Psychological status assessed by Hospital Anxiety and Depression Scale (HADS)

  Baseline, immediately after the 2-week treatment period, and at 1-month follow-up.

Study Arms (2)

Balneophysiotherapy plus Nanopulsed Electromagnetic Field Therapy Group

EXPERIMENTAL

Participants in the experimental group receive a standardized balneophysiotherapy program combined with nanopulsed electromagnetic field therapy (Super Inductive System) applied to the affected shoulder, delivered over 10 treatment days at the Balneal and Rehabilitation Sanatorium Techirghiol, Romania.

Device: Nanopulsed Electromagnetic Field Therapy (SIS)

Balneophysiotherapy Control Group

ACTIVE COMPARATOR

Participants allocated to the control group receive a structured two-week rehabilitation program comprising balneophysiotherapy interventions at the Balneal and Rehabilitation Sanatorium Techirghiol, Romania.

Other: Balneophysiotherapy

Interventions

Balneophysiotherapy OTHER

The intervention is based on the region's specific natural therapeutic resources and is conducted under continuous medical supervision. The treatment program includes saline therapeutic baths combined with exercise therapy and applications of sapropelic therapeutic mud, administered daily over a two-week period, five days per week. In addition, patients receive electrotherapy according to a standardized protocol, including magnetotherapy, interferential current therapy, and therapeutic ultrasound. The rehabilitation program also incorporates massage therapy and individualized therapeutic exercises.

Balneophysiotherapy Control Group

Nanopulsed Electromagnetic Field Therapy (SIS) DEVICE

Nanopulsed electromagnetic field therapy is delivered using the Super Inductive System (SIS) device applied to the affected shoulder. The intervention is administered daily over a two-week period, with a total of 10 sessions. Each session lasts approximately 10-15 minutes. The therapy delivers high-intensity electromagnetic pulses with adjustable frequency and intensity, aiming to reduce pain, stimulate tissue regeneration, and improve functional outcomes.

Balneophysiotherapy plus Nanopulsed Electromagnetic Field Therapy Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged between 18 and 70 years.
• Patients with chronic shoulder pain lasting more than 3 months, of non-traumatic origin, persistent despite prior conservative treatment.
• Clinical diagnosis of shoulder tendinopathy and/or subacromial pain syndrome based on medical history and physical examination.
• Presence of shoulder pain and functional limitation confirmed by clinical assessment and baseline functional evaluation (SPADI).
• Ability to comply with the treatment protocol and attend scheduled follow-up assessments.
• Provision of written informed consent prior to participation.

You may not qualify if:

• Full-thickness rotator cuff tears with surgical indication.
• Recent major shoulder trauma (within the last 6 months).
• Active systemic inflammatory or rheumatologic diseases.
• Presence of metallic implants in the treatment area or implanted electronic devices (e.g., pacemaker).
• Neurological disorders affecting the upper limb.
• Contraindications to balneotherapy (e.g., severe cardiovascular disease, renal failure, severe dermatological conditions).
• Decompensated chronic diseases at the time of enrollment (cardiovascular, hepatic, renal, respiratory, or neurological).
• Skin lesions at the site of treatment application.
• Pregnancy or breastfeeding.
• Active neoplastic disease.
• Decompensated psychiatric disorders.
• History of hypersensitivity to natural therapeutic factors used in balneotherapy.
• Refusal to participate or inability to provide informed consent.

Sponsors & Collaborators

• Balnear and Rehabilitation Sanatorium Techirghiol: lead

Study Sites (1)

Balneal and Rehabilitation Sanatorium of Techirghiol

Constanța, Techirghiol, 906100, Romania

RECRUITING

MeSH Terms

Conditions

Shoulder Pain; Tendinopathy

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Tendon Injuries; Wounds and Injuries

Central Study Contacts

Alexandra E Ciota, PhD Student

CONTACT

+40723662300; alexandra.ciota@365.univ-ovidius.ro

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Associate) Dr. Ionescu Elena-Valentina

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

RO (1)