Low-dose laser versus TENS for painful hemiplegic shoulder after stroke

Comparison of the Efficacy of Low-Dose Laser and Transcutaneous Electrical Nerve Stimulation in Subacute Hemiplegic Shoulder Pain, and the Effect of Treatments on Upper Extremity Function and Quality of Life

This test will try low-level laser therapy versus TENS to reduce moderate-to-severe shoulder pain in adults recovering from a recent stroke.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ankara Etlik City Hospital (other gov)
• Locations: 1 site (Ankara, Yenimahalle)
• Trial ID: NCT07203222 on ClinicalTrials.gov

What this trial studies

This interventional study enrolls adults aged 18–75 who had a stroke 2 weeks to 6 months earlier and have moderate-to-severe hemiplegic shoulder pain. Participants will receive low-level laser therapy, transcutaneous electrical nerve stimulation (TENS), or conventional physical therapy and will be followed for changes in pain, upper extremity function, quality of life, sleep, fatigue, and ultrasonographic findings. Pain will be measured using a visual analogue scale and validated functional and quality-of-life instruments, while ultrasonography will assess structural shoulder changes. The trial directly compares two commonly used noninvasive analgesic modalities to determine which provides greater symptomatic and functional benefit during early post-stroke rehabilitation.

Who should consider this trial

Good fit: Adults 18–75 with hemiplegic shoulder pain after a stroke within the past 2 weeks to 6 months, a VAS pain score of 40–100, and normal cognition (MMSE ≥25) are ideal candidates.

Not a fit: Patients with alternative explanations for shoulder pain, recent shoulder injections or botulinum toxin, implanted pacemakers or a history of epilepsy, pregnancy, significant motor aphasia, or prior shoulder surgery are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, one of these noninvasive treatments could reduce shoulder pain and improve arm function, sleep, and overall recovery during early post-stroke rehabilitation.

How similar studies have performed: Previous small trials and clinical reports have shown mixed but sometimes positive pain relief from both TENS and low-level laser therapy, so this head-to-head comparison addresses an area with promising but not definitive evidence.

Eligibility criteria

Inclusion Criteria:

* Patients aged 18-75 years
* Patients with shoulder pain on the hemiplegic side \*Mini mental state examination ≥ 25
* History of stroke within the last 2 weeks to 6 months
* Patients with shoulder pain scoring 40-100 points on the visual analogue scale (moderate to severe) will be included.

Exclusion Criteria:

* Patients who refuse to provide written consent or attend follow-up visits
* Being under 18 years of age
* Patients with motor aphasia
* Patients who have had a shoulder injection within the last 3 months
* Patients who have undergone upper extremity botulinum toxin application within the last 6 months

  \*Pregnant women or those planning to become pregnant
* Inflammatory rheumatic disease
* Patients who have undergone shoulder injury and surgery prior to stroke
* Patients with other conditions that could explain shoulder pain
* Patients with complex regional pain syndrome
* Patients with a history of epilepsy, pacemaker, or arrhythmia diagnosis
* Malignancy
* Diseases such as Alzheimer's or dementia that cause cognitive impairment -History of psychiatric disorders such as major depression or personality disorders
* Alcohol and drug addiction

Where this trial is running

Ankara, Yenimahalle

• Ankara Etlik City Hospital — Ankara, Yenimahalle, Turkey (Türkiye) (RECRUITING)

Study contacts

• Study coordinator: Aliye Aygün, specialist

Conditions: Hemiplegic Shoulder Pain, Hemiplegic shoulder pain, Low Dose Laser, TENS, Ultrasonographic evaluation, Upper extremity function, stroke