Clinical trial NCT06988228: The Effects of 15% Dextrose Solution on Pain and Range of Motion in the Hemiplegic Shoulder
Official title: The Effects of 15% Dextrose Solution on Pain and Range of Motion in the Hemiplegic Shoulder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hemiplegic Shoulder Pain
Stroke
Keywords: %15 prolotherapy
%15 dextrose injection
hemiplegic shoulder pain
post-stroke rehabilitation
fugl-meyer
barthel ındex
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-23
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity measured by Visual Analog Scale (VAS, 0-10 cm; higher scores = worse pain)
timeFrame: Baseline, 1 month after last injection, 3 months after last injection
Secondary outcomes:
measure: Shoulder Range of Motion (ROM) measured using a standard goniometer (abduction and flexion, degrees)
timeFrame: Baseline, 1 month after last injection, 3 months after last injection
measure: Barthel Index Score (range 0-100; higher scores = better functional independence)
timeFrame: Baseline, 1 month after last injection, 3 months after last injection
measure: Fugl-Meyer Assessment - Upper Extremity (Shoulder Subsection) Score (range 0-40; higher scores = better motor function)
timeFrame: Baseline, 1 month after last injection, 3 months after last injection
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
state: Bahçelievler
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.