Efficacy of Prolotherapy and Hydrodilatation for Frozen Shoulder
- Conditions
- Frozen Shoulder
- Interventions
- Other: injection
- Registration Number
- NCT05448794
- Lead Sponsor
- Tri-Service General Hospital
- Brief Summary
Objective: To determine whether ultrasound-guided Intra-Articular Hypertonic Dextrose and hydrodilatation improves pain and function in patients with frozen shoulder(FS)
- Detailed Description
Setting: a medical center hospital. Participants: Subjects with primary FS with shoulder pain more than 3 months. Interventions: Participants randomly be assigned into A and B group: group A received ultrasound-guided hydrodilatation with hypertonic Dextrose with a mixture of 2mL of 50%, 1mL of 2% lidocaine, and 6ml normative saline ; group B : ultrasound-guided hydrodilatation with 9 mL of normative saline and 1 mL of 2% lidocaine.
Main Outcome Measures: The primary outcome measure was the Shoulder Pain and Disability Index score. Secondary outcomes were the VAS of shoulder pain level, muscle power and angles of shoulder passive range of motion, including flexion, abduction, extension, external rotation, and internal rotation at pretreatment and weeks 2, 4, 8, 12 and 24 of post-treatment.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description evaluation prolotherapy for frozen shoulder injection This pilot study highlighted that prospective studies are required to prove its clinical application for FS and other conditions.
- Primary Outcome Measures
Name Time Method the Shoulder Pain and Disability Index score 2 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tri-Service General Hospital
🇨🇳Taipei, Alberta, Taiwan