Hemiplegic Shoulder Pain, Stroke
Conditions
Keywords
%15 prolotherapy, %15 dextrose injection, hemiplegic shoulder pain, post-stroke rehabilitation, fugl-meyer, barthel ındex
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 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.
Interventions
BIOLOGICAL15% Dextrose Injection
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.
OTHERizotonic saline injection
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.
Sponsors
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
This is a single-blinded study. Participants are blinded to the type of solution (dextrose or isotonic saline) administered during the injections.
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity measured by Visual Analog Scale (VAS, 0-10 cm; higher scores = worse pain) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Barthel Index Score (range 0-100; higher scores = better functional independence) | 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. |
| 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 | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed