The Effects of 15% Dextrose Solution on Pain and Range of Motion in the Hemiplegic Shoulder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pain intensity measured by Visual Analog Scale (VAS, 0-10 cm; higher scores = worse pain)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
This is a single-blinded study. Participants are blinded to the type of solution (dextrose or isotonic saline) administered during the injections.
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
intervention group
Participants in this group will receive three sessions of 15% dextrose solution injections at two-week intervals, in addition to conventional exercise therapy.
Intervention: 15% Dextrose Injection (Biological)
control group
Participants in this group will receive three sessions of isotonic saline solution injections at two-week intervals, in addition to conventional exercise therapy.
Intervention: izotonic saline injection (Other)
Outcomes
Primary Outcomes
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
- 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)
Investigators
ayseyildirim
principal investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital