NCT06988228

The Effects of 15% Dextrose Solution on Pain and Range of Motion in the Hemiplegic Shoulder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Other Government
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the effects of 15% dextrose solution on pain and range of motion in patients aged 40 to 75 years who have experienced a stroke and suffering from hemiplegic shoulder pain

Detailed description

This randomized, controlled, single-blinded clinical trial aims to evaluate the effects of 15% dextrose solution on pain and shoulder range of motion in patients with hemiplegic shoulder pain following a stroke. A total of 40 participants aged 40 to 75 years will be enrolled and randomly assigned into two groups of equal size. Both groups will receive conventional exercise therapy. In addition, the intervention group will receive three sessions of 15% dextrose solution injections administered at two-week intervals, whereas the control group will receive three sessions of isotonic saline solution injections on the same schedule. Assessments will be conducted at baseline, one month after the final injection, and three months after the final injection. The primary outcome measure is the change in pain intensity. Secondary outcome measures include goniometric range of motion (ROM) evaluation, Visual Analog Scale (VAS), Barthel Index for functional independence, and the shoulder section of the Fugl-Meyer Upper Extremity Motor Assessment Scale(Shoulder subsection). This study aims to determine whether 15% dextrose prolotherapy offers superior clinical outcomes in reducing pain and improving functional status compared to isotonic saline injection when combined with a standard exercise program.

Conditions

• Hemiplegic Shoulder Pain
• Stroke

Interventions

Type	Name	Description
BIOLOGICAL	15% Dextrose Injection	15% dextrose solution will be administered by injection in three sessions at two-week intervals. It will be applied in combination with conventional exercise therapy.
OTHER	izotonic saline injection	Participants will receive isotonic saline solution injections in three sessions at two-week intervals, as a placebo comparator to the 15% dextrose injections. All participants will also receive conventional exercise therapy.

Timeline

• Start date: 2024-12-24
• Primary completion: 2025-08-01
• Completion: 2025-09-01
• First posted: 2025-05-23
• Last updated: 2026-01-09

Locations

1 site across 1 country: Turkey (Türkiye)