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

NCT06988228 | Completed

• 2 other identifiers: SBUSAH-GETAT 2024-057SBUSAH-GETAT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Hemiplegic Shoulder Pain; Stroke

Keywords

%15 prolotherapy; %15 dextrose injection; hemiplegic shoulder pain; post-stroke rehabilitation; fugl-meyer; barthel ındex

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, 1 month after last injection, 3 months after last injection

Secondary Outcomes (3)

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

  Baseline, 1 month after last injection, 3 months after last injection

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

  Baseline, 1 month after last injection, 3 months after last injection

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

  Baseline, 1 month after last injection, 3 months after last injection

Study Arms (2)

intervention group

EXPERIMENTAL

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

Biological: 15% Dextrose Injection

control group

PLACEBO COMPARATOR

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

Other: izotonic saline injection

Interventions

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.

intervention group

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.

control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, bahçelievler, 34186, Turkey (Türkiye)

Location

Related Publications (5)

• Coskun Benlidayi I, Basaran S. Hemiplegic shoulder pain: a common clinical consequence of stroke. Pract Neurol. 2014 Apr;14(2):88-91. doi: 10.1136/practneurol-2013-000606. Epub 2013 Aug 12.

  PMID: 23940374 BACKGROUND

• Hauser RA, Lackner JB, Steilen-Matias D, Harris DK. A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2016 Jul 7;9:139-59. doi: 10.4137/CMAMD.S39160. eCollection 2016.

  PMID: 27429562 BACKGROUND

• Thor JA, Mohamed Hanapi NH, Halil H, Suhaimi A. Perineural Injection Therapy in the Management of Complex Regional Pain Syndrome: A Sweet Solution to Pain. Pain Med. 2017 Oct 1;18(10):2041-2045. doi: 10.1093/pm/pnx063. No abstract available.

  PMID: 28460075 BACKGROUND

• Kumar P. Hemiplegic shoulder pain in people with stroke: present and the future. Pain Manag. 2019 Mar 1;9(2):107-110. doi: 10.2217/pmt-2018-0075. Epub 2019 Jan 25. No abstract available.

  PMID: 30681020 BACKGROUND

• Mansiz-Kaplan B, Nacir B, Pervane-Vural S, Tosun-Meric O, Duyur-Cakit B, Genc H. Effect of Perineural Dextrose Injection on Ulnar Neuropathy at the Elbow: A Randomized, Controlled, Double-Blind Study. Arch Phys Med Rehabil. 2022 Nov;103(11):2085-2091. doi: 10.1016/j.apmr.2022.04.013. Epub 2022 Jun 9.

  PMID: 35690093 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Glucose

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blinded study. Participants are blinded to the type of solution (dextrose or isotonic saline) administered during the injections.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: The study includes two parallel groups. Both receive conventional exercise therapy. The intervention group receives three sessions of 15% dextrose solution injections, and the control group receives three sessions of isotonic saline solution injections, administered at two-week intervals.

Study Record Dates

• First Submitted: May 17, 2025
• First Posted: May 23, 2025
• Study Start: December 24, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 9, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 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.
• Access Criteria: 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.

Locations

TU (1)