Comparison of the Effectiveness of TENS and TENS + NMES Treatment in Stroke Patients With Shoulder Pain

NCT07353190 | Not Yet Recruiting

• 1 other identifier: 2025-5/13
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the effects of Transcutaneous Electrical Nerve Stimulation (TENS) and Neuromuscular Electrical Stimulation (TENS + NMES) applied in addition to TENS on pain, shoulder joint range of motion and upper extremity functions will be comparatively evaluated in stroke patients with hemiplegic shoulder pain. In this direction, in the study; The effectiveness of both treatment approaches on the severity of hemiplegic shoulder pain, their contribution to shoulder functionality and daily living activities will be examined; It will be investigated whether NMES application added to TENS provides an additional clinical benefit compared to TENS.

Conditions

Shoulder Disease; Hemiplegia; Hemiplegic Shoulder Pain; Stroke

Keywords

stroke; shoulder pain; TENS; NMES

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  Hemiplegic Shoulder Pain Severity; The severity of shoulder pain on the hemiplegic side will be evaluated using the visual analogue scale VAS. Participants will rate their pain level from 0 (no pain) to 10 (the worst pain imaginable). Pain assessment will be performed at rest and/or during shoulder movement.

  4 weeks

Study Arms (2)

Transcutaneous Electrical Nerve Stimulation (TENS)

ACTIVE COMPARATOR

Participants in this group will receive Transcutaneous Electrical Nerve Stimulation (TENS) in addition to the standard stroke rehabilitation program. TENS application will be performed with appropriate electrode placement in the hemiplegic shoulder area for pain control. The intensity of application will be adjusted to a level that the participant can tolerate and will create a distinct sensory perception. Neuromuscular Electrical Stimulation (NMES) will not be applied in this group.

Procedure: TENS; Other: NMES

Transcutaneous Electrical Nerve Stimulation (TENS) and Neuromuscular Electrical Stim

ACTIVE COMPARATOR

Participants in this group will receive Transcutaneous Electrical Nerve Stimulation (TENS) in addition to the standard stroke rehabilitation program and Neuromuscular Electrical Stimulation (NMES) in addition to TENS. TENS application will be applied to the hemiplegic shoulder area for pain control. NMES application will be applied to target the paretic muscle groups involved in shoulder stabilization, aiming to achieve visible muscle contraction. It will be evaluated whether this combination provides additional clinical benefit in pain, shoulder function, and upper extremity use compared to TENS alone.

Procedure: TENS; Other: NMES

Interventions

TENS PROCEDURE

Transcutaneous Electrical Nerve Stimulation (TENS) will be applied to reduce hemiplegic shoulder pain. The stimulation will be delivered to the hemiplegic shoulder region using appropriate electrode placement. TENS parameters, including frequency, pulse duration, and treatment duration, will be set according to standard clinical practice. Stimulation intensity will be adjusted to produce a clear but comfortable sensory perception without causing discomfort. TENS will be administered in addition to the standard stroke rehabilitation program.

Transcutaneous Electrical Nerve Stimulation (TENS); Transcutaneous Electrical Nerve Stimulation (TENS) and Neuromuscular Electrical Stim

NMES OTHER

Neuromuscular Electrical Stimulation (NMES) will be applied in addition to TENS to activate paretic muscle groups involved in shoulder stabilization. NMES will be delivered to target muscles in order to elicit visible muscle contractions. Stimulation parameters, including frequency, pulse duration, contraction-relaxation cycles, and total treatment time, will be determined in accordance with standard clinical practice and adjusted based on participant safety and tolerance. NMES will be provided as an adjunct to both TENS and the standard stroke rehabilitation program.

Transcutaneous Electrical Nerve Stimulation (TENS); Transcutaneous Electrical Nerve Stimulation (TENS) and Neuromuscular Electrical Stim

Eligibility Criteria

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

You may qualify if:

• Individuals aged 18 and over
• Patients with a history of clinically and radiologically confirmed ischemic or hemorrhagic stroke
• Hemiplegic shoulder pain in the affected shoulder
• Shoulder pain severity VAS/NRS ≥ 2
• At least 2 weeks and at most 1 year have passed since the onset of stroke
• Have a level of cognitive and communicative competence that will not hinder the application of clinical evaluations and scales
• Must have signed the Informed Volunteer Consent Form to participate in the study.
• Must have a general medical condition to participate in a conventional rehabilitation program

Sponsors & Collaborators

• Medical Park Bursa Hospital: lead

MeSH Terms

Conditions

Stroke; Hemiplegia; Shoulder Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor lecturer

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 20, 2026
• Study Start: February 1, 2026
• Primary Completion: April 28, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share