Randomize Controlled Comparative Study on efficacy of Hydrodilatation with steroid VS Intra-articular steroid injection for treatment of frozen shoulder using rotator interval approach

Comparative efficacy of Hydrodilatation vs Intra-articular injection for treatment of frozen shoulder; rotator interval approach: Randomized Controlled Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20251110002

Enrollment

Registered

2025-11-10

Start date

2025-11-06

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Frozen shoulder Hydrodilatation, Intra-articular injection, Rotator interval, Frozen shoulder, Randomized Controlled Trial

Interventions

Hydrodilate affected glenohumeral joint via rotator interval approach under ultrasound guidance with fluid consisting of triamcinolone acetonide (40mg/ml) 1ml, 2% xylocaine without adrenaline 4 ml and

Experimental Procedure/Surgery,Active Comparator Procedure/Surgery

Hydrodilatation with Steroid,- Intra-articular steroid injection

Eligibility

Sex/Gender

All

Age

20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Shoulder pain and limited shoulder passive range of motion (PROM), onset between 2 weeks and 1 years. 2. Pain score (Numerical Rating Scale: NRS) at least 4 out of 10 3. Physical examination shows limited passive shoulder ROM in at least 2 of the following planes, forward flexion or abduction less than or equal to 150 degrees, internal rotation or external rotation less than or equal to 60 degrees.

Exclusion criteria

Exclusion criteria: 1. Imaging study (plain film and diagnostic ultrasound) of the affected shoulder found abnormality such as calcified deposit in the rotator cuff tendon, locked posterior glenohumeral dislocation, degenerative glenohumeral arthritis, rotator cuff tear 2. Bone fracture from elbow joint to shoulder area 3. Post-operative shoulder stiffness 4. Septic arthritis with or without osteomyelitis 5. Inflammatory glenohumeral arthritis from rheumatoid arthritis, polymyalgia rheumatica 6. Neurological disorder causing shoulder muscle weakness and/or spasticity 7. Malignancy 8. Pregnancy 9. Severe mental and/or cognitive function disorder 10. Patients who has received steroid injection in the shoulder area in less than 3 months of the screening procedure 11. History of allergic reaction to xylocaine 12. For patients who are currently taking anticoagulants, INR more than 2.5 on the day of the procedure.

Design outcomes

Primary

Measure	Time frame
Shoulder Function Base line, 2 weeks and 6 weeks post intervention Shoulder Pain and Disability Index (SPADI), Thai version	—

Secondary

Measure	Time frame
Pain Intensity Base line, 2 weeks and 6 weeks post intervention Numeric Rating Scale (NRS),Passive Range of Motion Base line, 2 weeks and 6 weeks post intervention Manual goniometer measurement	—

Countries

Thailand

Contacts

Public ContactDuangporn Kattinanon

Sa Kaeo Crown Prince Hospital

fonjungka@gmail.com6637243018

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026