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

Not Applicable

Active, not recruiting

• Conditions: Hemiplegic Shoulder Pain; Stroke
• Interventions: Biological: 15% Dextrose Injection; Other: izotonic saline injection

• Registration Number: NCT06988228
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Brief 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 36 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.

Study Timeline

• Study Start: 2024-12-24
• Status Verified: 2025-05
• Study First Submitted: 2025-05-17
• Study First Submitted QC: 2025-05-17
• Last Update Submitted: 2025-05-17
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-07-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	15% Dextrose Injection	Participants in this group will receive three sessions of 15% dextrose solution injections at two-week intervals, in addition to conventional exercise therapy.
control group	izotonic saline injection	Participants in this group will receive three sessions of isotonic saline solution injections at two-week intervals, in addition to conventional exercise therapy.

Primary Outcome Measures

Name	Time	Method
Pain Intensity in Different Conditions Using the Visual Analog Scale (VAS)	Baseline, 1 month after last injection, 3 months after last injection	Pain intensity will be assessed using a 10 cm Visual Analog Scale (VAS) in three different conditions: at rest, after exercise, and during daily activities. Participants will be asked to rate their pain separately for each condition. The change in VAS scores from baseline to 1 and 3 months after the final injection will be evaluated.

Secondary Outcome Measures

Name	Time	Method
Shoulder Range of Motion (ROM) by Goniometer	Baseline, 1 month after last injection, 3 months after last injection	Passive and active shoulder abduction and flexion range of motion will be measured using a standard goniometer.
Barthel Index Score	Baseline, 1 month after last injection, 3 months after last injection	Functional independence will be assessed using the Barthel Index.
Fugl-Meyer Upper Extremity Score (Shoulder Subsection)	Baseline, 1 month after last injection, 3 months after last injection	The shoulder-specific items of the Fugl-Meyer Upper Extremity scale will be used to assess motor recovery.

Trial Locations

Locations (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital; 🇹🇷 Istanbul, Bahçelievler, Turkey