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Comparing PRP, Corticosteroid, and Combined Therapy for Frozen Shoulder in People With or Without Diabetes

A Randomized Controlled Trial Comparing Platelet-Rich Plasma, Corticosteroid Injections, and Combination Therapy in Patients with Idiopathic and Diabetic Adhesive Capsulitis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250718066536N2
Enrollment
100
Registered
2025-08-18
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Capsulitis (Frozen Shoulder), Idiopathic and Diabetic. Adhesive capsulitis of shoulder

Interventions

Intervention 1: Intervention group: Single intra-articular injection of 4 mL platelet-rich plasma (activated with thrombin, 1:10) mixed with 4 mL of 2% lidocaine and diluted with distilled water to a

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 78 Years

Inclusion criteria

Inclusion criteria: Age between 30 and 75 years; unilateral frozen shoulder diagnosed by physical examination and clinical evaluation; shoulder pain persisting for at least one month; loss of at least one-third of the range of motion in various shoulder movements; normal shoulder joint radiography; normal neurological examination of the proximal upper limb; and no prior pain relief interventions for the affected shoulder.

Exclusion criteria

Exclusion criteria: History of previous treatments aimed at reducing shoulder pain, such as intra-articular injections; unwillingness to continue participation in the study; any intra-articular pathology of the glenohumeral joint or shoulder pain due to other causes; history of trauma or shoulder surgery; clinical evidence of Sudeck’s atrophy syndrome; injection in the affected shoulder joint within the past six months; use of non-steroidal anti-inflammatory drugs in the last seven days; presence of blood disorders or current antiplatelet or anticoagulant treatment; presence of thyroid or lung disorders, particularly emphysema and chronic bronchitis; neoplastic disorders; pregnancy or breastfeeding; uncontrolled diabetes; neurological, rheumatological, malignant, or immunodeficiency diseases; history of drug or alcohol use or addiction; and cervical radiculopathy.

Design outcomes

Primary

MeasureTime frame
Change in shoulder pain, disability (SPADI, VAS), and range of motion measured at baseline, 4 weeks, and 8 weeks after treatment. Timepoint: Baseline, 4 weeks, and 8 weeks after intervention. Method of measurement: Shoulder Pain and Disability Index questionnaire.

Secondary

MeasureTime frame
Change in pain intensity score measured by the Visual Analogue Scale from baseline to 8 weeks after intervention. Timepoint: Baseline, 4 weeks, and 8 weeks after intervention. Method of measurement: Measured using a goniometer for shoulder range of motion.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Saeed Enayati

Islamic Azad University

info@iau-shahrood.ac.ir+98 23 3239 5001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026