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

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.

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Key information

Conditions

Stroke Arthralgia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Hemiplegic Shoulder Pain Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pain Paralysis Pathological Conditions, Signs and Symptoms Shoulder Disease Shoulder Pain Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Hemiplegic shoulder pain that develops after stroke is a common complication that negatively affects upper extremity functions, shoulder joint range of motion (ROM) and daily living activities. Muscle weakness accompanying the pain, loss of activation of the shoulder girdle muscles, subluxation, spasticity and limitation of movement; It may delay the recovery process by reducing rehabilitation participation. While Transcutaneous Electrical Nerve Stimulation (TENS), one of the electrophysical agents, is a widely used method in pain modulation, Neuromuscular Electrical Stimulation (NMES) has the potential to increase paretic muscle activation, support shoulder stabilization and improve functional gains. However, there is limited evidence as to whether NMES added to TENS provides additional clinical benefit in hemiplegic shoulder pain.The aim of this randomized controlled clinical study was to compare TENS and TENS + NMES applications in stroke patients with hemiplegic shoulder pain; To evaluate the effects on (i) pain intensity, (ii) shoulder joint range of motion, (iii) upper extremity functions and (iv) daily living activities. The main hypothesis of the study is that NMES added to TENS will provide a greater reduction in pain and a more significant improvement in shoulder function/upper extremity use compared to TENS alone.

Study Design

This study is a prospective, parallel group, randomized controlled clinical trial to be conducted in stroke patients with hemiplegic shoulder pain. Participants will be divided into two branches:

TENS Group: TENS will be applied in addition to the standard rehabilitation program.

TENS + NMES Group: TENS will be applied in addition to standard rehabilitation; Additionally, NMES will be applied in addition to TENS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

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.

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.

Primary outcomes

Visual Analog Scale

Time frame: 4 weeks

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.

Sponsors and collaborators

Lead sponsor

Medical Park Bursa Hospital

Other

Registry information

Official study title

Comparison of the Effectiveness of TENS and TENS + NMES Treatment in Stroke Patients With Shoulder Pain: Prospective Randomized Controlled Study

Acronym: TENS

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jan 20, 2026
Registry last updated: Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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