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

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Status: Completed

Conditions: Stroke; Hemiplegic Shoulder Pain

Treatments: Other: izotonic saline injection; Biological: 15% Dextrose Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06988228

SBUSAH-GETAT 2024-057

SBUSAH-GETAT (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

intervention group

Experimental group

Description:

Participants in this group will receive three sessions of 15% dextrose solution injections at two-week intervals, in addition to conventional exercise therapy.

Treatment:

Biological: 15% Dextrose Injection

control group

Placebo Comparator group

Description:

Participants in this group will receive three sessions of isotonic saline solution injections at two-week intervals, in addition to conventional exercise therapy.

Treatment:

Other: izotonic saline injection