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

January 15, 2026 updated by: Sevinç Külekçioğlu, Medical Park Bursa Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transcutaneous Electrical Nerve Stimulation (TENS)
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
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.
Other: NMES
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.
Active Comparator: Transcutaneous Electrical Nerve Stimulation (TENS) and Neuromuscular Electrical Stim
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
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.
Other: NMES
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Park Bursa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

April 28, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 27, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-5/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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