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NCT Number: NCT06988228

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

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

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Key information

Conditions

Hemiplegic Shoulder Pain Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, bahçelievler, 34186, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

15% Dextrose Injection

Biological

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.

izotonic saline injection

Other

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.

Primary outcomes

  1. Pain intensity measured by Visual Analog Scale (VAS, 0-10 cm; higher scores = worse pain)

    Time frame: Baseline, 1 month after last injection, 3 months after last injection

    Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-centimeter scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse outcomes (greater pain intensity). Pain will be evaluated in three different conditions: at rest, after exercise, and during daily activities. Participants will rate their pain separately for each condition. The change in VAS scores from baseline to 1 month and 3 months after the final injection will be evaluated.

Secondary outcomes

  1. Shoulder Range of Motion (ROM) measured using a standard goniometer (abduction and flexion, degrees)

    Time frame: Baseline, 1 month after last injection, 3 months after last injection

    Shoulder joint mobility will be assessed using a standard manual goniometer. Active range of motion will be measured in degrees for shoulder abduction and flexion only. Measurements will be taken on the affected (hemiplegic) side with the participant in a seated position. Higher values indicate better outcomes (greater joint mobility). Changes from baseline to 1 month and 3 months after the final injection will be evaluated.

  2. Barthel Index Score (range 0-100; higher scores = better functional independence)

    Time frame: Baseline, 1 month after last injection, 3 months after last injection

    Functional independence in activities of daily living (ADLs) will be assessed using the Barthel Index, a standardized scale that evaluates a person's ability to perform 10 basic self-care and mobility tasks. The total score ranges from 0 to 100, with higher scores indicating better functional status and greater independence. The change in Barthel Index scores from baseline to 1 month and 3 months after the final injection will be analyzed.

  3. Fugl-Meyer Assessment - Upper Extremity (Shoulder Subsection) Score (range 0-40; higher scores = better motor function)

    Time frame: Baseline, 1 month after last injection, 3 months after last injection

    Motor function of the affected upper limb will be assessed using the shoulder subsection of the Fugl-Meyer Assessment of Upper Extremity (FMA-UE). This subsection evaluates reflex activity, voluntary movement within and outside synergy patterns, and coordination of shoulder and elbow movements. The score ranges from 0 to 40, with higher scores indicating better motor recovery. Changes from baseline to 1 month and 3 months after the final injection will be analyzed.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 23, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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