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Hemiplegic Shoulder PainNCT06988228

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

A study testing 15% Dextrose Injection and izotonic saline injection in people with Hemiplegic Shoulder Pain and Stroke, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Hemiplegic Shoulder Pain, Stroke
What is being tested?
15% Dextrose Injection and izotonic saline injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
24 Dec 2024to 1 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

    Istanbul, bahçelievler, 34186

Other trials in Turkey (Türkiye)

About this study

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

Read the 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 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.

Being tested
15% Dextrose Injection, izotonic saline injection
Keywords
%15 prolotherapy, %15 dextrose injection, hemiplegic shoulder pain, post-stroke rehabilitation, fugl-meyer, barthel ındex
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 15% Dextrose InjectionBiological

    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 injectionOther

    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.

Study groups in NCT06988228
Study groupRoleWhat they receive
intervention groupExperimentalParticipants in this group will receive three sessions of 15% dextrose solution injections at two-week intervals, in addition to conventional exercise therapy.
Receives: Biological: 15% Dextrose Injection
control groupPlacebo comparatorParticipants in this group will receive three sessions of isotonic saline solution injections at two-week intervals, in addition to conventional exercise therapy.
Receives: Other: izotonic saline injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

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

    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.

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

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

    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.

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

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2025
  2. Study start24 Dec 2024
  3. Primary completion1 Aug 2025
  4. Study completion1 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06988228
Sponsor's protocol ID
SBUSAH-GETAT 2024-057
Other IDs
SBUSAH-GETAT
Status last verified
May 2025
First submitted
17 May 2025
Last updated
9 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 23940374

  • 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.

    PubMed 27429562

  • 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.

    PubMed 28460075

  • 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.

    PubMed 30681020

  • 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.

    PubMed 35690093

Questions about this trial

What is this clinical trial studying?

A study testing 15% Dextrose Injection and izotonic saline injection in people with Hemiplegic Shoulder Pain and Stroke, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06988228, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.

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