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

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.

Inclusion Criteria:

Patients aged between 40 and 75 years

History of stroke

Brunnstrom stage 2 or higher in the upper extremity

Provided written informed consent and agreed to participate in the study

Exclusion Criteria:

History of any prior injection therapy to the shoulder region

Previous radiotherapy or surgery involving the shoulder

Pre-stroke shoulder pain

History of shoulder surgery

History of inflammatory joint disease

Presence of neuromuscular disorders

Full-thickness rotator cuff tear

Patients with aphasia or severe cognitive impairment

Presence of pectoral muscle spasticity

Active malignancy with acute inflammation at the treatment site

Known coagulation disorder with INR ≥ 4

Presence of vascular conditions such as deep vein thrombosis, phlebitis, varicose veins, or arterial disease in the affected limb

De-identified individual participant data (IPD) will be available upon reasonable request from qualified researchers after the publication of study results. Data sharing will require approval by the principal investigator and compliance with ethical guidelines.

De-identified IPD and supporting information will be available 6 months after publication of the primary results and will remain accessible for up to 3 years.

Qualified researchers may request access to the IPD and supporting documents. Requests will be reviewed and approved by the principal investigator. A data use agreement and adherence to ethical standards will be required.

This is a single-blinded study. Participants are blinded to the type of solution (dextrose or isotonic saline) administered during the injections.