An interventional study of Laser therapy and Transcutaneus electirical nerve stimulation in Hemiplegic Shoulder Pain, sponsored by Hitit University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Hitit University · Not applicable, Interventional, and Treatment
This study aimed to investigate whether laser and Transcutaneous Electirical Nerve Stimulationapplied in addition to conventional physical therapy exercises in hemiplegic shoulder pain seen in patients with stroke provides an additional contribution to pain, range of motion, spasticity, upper extremity functions and whether the two treatment types are superior to each other.
Stroke is one of the most devastating neurological disorders, affecting approximately 9 million people worldwide annually. With increasing life expectancy, stroke remains a major cause of morbidity and mortality. The introduction of effective treatment strategies in the acute phase has led to increased expectations regarding prognosis. Nevertheless, secondary complications following stroke are frequently encountered and may significantly hinder the rehabilitation process.
The upper extremity is affected more frequently than the lower extremity, and functional recovery of the upper extremity is generally more challenging and slower. Shoulder problems account for a substantial proportion of upper extremity functional impairments. One of the major contributing factors to these problems is impaired shoulder biomechanics. Shoulder pain may develop within the first two weeks following stroke, although it typically occurs between one and three months after stroke.
The etiology of hemiplegic shoulder pain (HSP) is multifactorial and may involve several contributing factors, including shoulder subluxation, complex regional pain syndrome type I, biceps tendinopathy, rotator cuff abnormalities, adhesive capsulitis, and increased muscle tone. Stroke survivors frequently experience impairments in upper extremity motor function and manual dexterity, which may subsequently lead to difficulties in performing activities of daily living. Effective pain management can reduce pain intensity, enhance patients' participation in rehabilitation, and contribute to improvements in joint range of motion and functional capacity.
Various physical therapy modalities are used in the management of HSP. One such modality is laser therapy, an acronym for Light Amplification by Stimulated Emission of Radiation. The fundamental principles of laser technology are based on quantum theory and the concept of stimulated emission. The first functional laser device was developed by Theodore Maiman in 1960. Laser devices generate and amplify light through stimulated emission of radiation within a specific active medium. Laser therapy is thought to exert beneficial effects on pain reduction, joint range of motion, and upper extremity function. In clinical practice, laser therapy is used to exploit its potential regenerative, biostimulatory, analgesic, anti-inflammatory, and anti-edematous effects. Its efficacy has previously been investigated in musculoskeletal conditions such as knee osteoarthritis and adhesive capsulitis of the shoulder, as well as in patients with hemiplegia.
Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological intervention used in the management of acute and chronic pain. TENS devices deliver pulsed electrical currents through electrodes placed on the skin and are generally considered safe and relatively inexpensive. Stimulation parameters, including pulse frequency and intensity, can be adjusted according to clinical requirements and may influence the therapeutic response to TENS.
The aim of this study is to investigate whether laser therapy and TENS, when administered in addition to conventional physical therapy exercises in patients with HSP following stroke, provide additional benefits in terms of pain, joint range of motion, spasticity, and upper extremity function. The study also aims to compare the efficacy of these two treatment modalities and determine whether either modality is superior to the other.
Materials and Methods
Study Design and Participants
This prospective, randomized controlled study is planned to include 60 patients aged 18-85 years who will present to the Physical Medicine and Rehabilitation Outpatient Clinic between November 2026 and September 2028. Eligible participants will have a first-ever ischemic stroke and shoulder pain.
Randomization and Blinding
Eligible participants will be randomly allocated to three groups using the sealed-envelope method, with the allocation process conducted by the same physiotherapist. Owing to the nature of the interventions, the physiotherapist administering the treatments will be aware of the participants' group assignments. However, all outcome assessments are planned to be performed by the same researcher, who will be blinded to treatment allocation.
Rehabilitation Protocol
All participants will undergo a multidisciplinary rehabilitation program consisting of 20 sessions over four weeks, with treatment administered five days per week. Conventional physical therapy exercises will be tailored to each patient's individual needs and neurological status.
The exercise program will be determined by the physiotherapist according to each patient's functional status and will include passive, active-assisted, and active range-of-motion exercises, stretching and strengthening exercises, and mobilization techniques.
Treatment Groups
Group 1: Laser therapy group (n = 20)
Participants in this group will receive laser therapy for five minutes per session, three days per week, in addition to conventional physical therapy.
Group 2: TENS group (n = 20)
Participants in this group will receive TENS for 20 minutes per session, five days per week, in addition to conventional physical therapy.
Group 3: Control group (n = 20)
Participants in this group will receive conventional physical therapy exercises alone.
735 studies on the registry are indexed under Shoulder Pain; 167 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 587 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Hitit University is the lead sponsor of 87 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The implementation of conventional physical therapy exercises was planned in accordance with the patient's individual needs and neurological level. These exercises were determined by the physiotherapist based on the patient's functional status and were planned to comprise range of motion (ROM) exercises-including passive, active-assisted, and active exercises-as well as stretching, strengthening, and mobilization exercises. Group 1 was designated as the laser therapy group (n=20); in addition to conventional physical therapy, laser therapy was applied to the shoulder muscle group for 5 minutes per day, 3 days a week, over a period of 4 weeks.
Other: Laser therapy
The implementation of conventional physical therapy exercises tailored to the patient's individual needs and neurological level was planned. These exercises are determined by the physiotherapist based on the patient's functional status and were planned to comprise passive, active-assisted, and active range of motion (ROM) exercises, stretching and strengthening exercises, and mobilization exercises. In the transcutaneous electrical nerve stimulation (TENS) group, in addition to these exercises, TENS was applied to the shoulder flexor and abductor muscle groups for 20 minutes per day, 5 days a week, for a total duration of 4 weeks.
Other: Transcutaneus electirical nerve stimulation
The implementation of conventional physical therapy exercises tailored to the patient's individual needs and neurological level was planned. These exercises are determined by the physiotherapist based on the patient's functional status and were planned to comprise passive, active-assisted, and active range of motion (ROM) exercises, stretching and strengthening exercises, and mobilization exercises.
Other: control
In addition to conventional physical therapy, laser therapy was planned to be applied to the shoulder muscle group for 5 minutes per day, 3 days a week, over a period of 4 weeks
In the transcutaneous electrical nerve stimulation (TENS) group, in addition to these exercises, TENS was planned to be applied to the shoulder flexor and abductor muscle groups for 20 minutes per day, 5 days a week, for a total duration of 4 weeks.
The implementation of conventional physical therapy exercises tailored to the patient's individual needs and neurological level was planned. These exercises are determined by the physiotherapist based on the patient's functional status and comprise passive, active-assisted, and active range of motion (ROM) exercises, stretching and strengthening exercises, and mobilization exercises.
Pain Level
The pain level of the patients will be measured with a scale given to the patient; visual pain scale. Patients rate their pain on a scale of 0-10. It consists of scores ranging from 0 (no pain) to 10 (most severe pain). Higher scores indicate more severe pain.
Time frame: baseline and through study completion, an average of 4 weeks
Disability
The Shoulder Pain and Disability Index is a patient-completed scale consisting of 5 items on pain and 8 items on disability. Each item is marked by the patient on a 0-10 cm scale. High scores indicate high pain and disability.
Time frame: baseline and through study completion, an average of 4 weeks
Spasticity
The Modified Ashworth Scale, the most widely used scale for tonus assessment, was used to evaluate spasticity. In this scale, muscle tone is evaluated between 0 normal and 4 being rigid. In our study, spasticity in shoulder adductors and internal rotators, forearm flexors, wrist flexors and finger flexors were recorded by the same investigator.
Time frame: baseline and through study completion, an average of 4 weeks
Recovery Stage
Brunnstrom Recovery Stage is a 6-step scale that includes movement patterns with progressively increasing recovery evaluated separately for upper extremity, hand and lower extremity. 0: no movement, 6: full movement. Higher values indicate better motor recovery and were recorded by the same investigator.
Time frame: baseline and through study completion, an average of 4 weeks
Plan to share: Yes — The sharing of changes in patients' pain levels is planned.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Sep 2028, 22 months later.
Of 349 non-industry interventional studies with no phase under Shoulder Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 22 months is above that.
Counting every sponsor, half of 354 studies reached it within 11 months; a quarter within 4 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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