NCT02944526

The Effect of 3 Ropivacaine Suprascapular Nerve Blocks in Subacute Adhesive Capsulitis: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Clinique Saint-Jean, Bruxelles · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Patients presenting with subacute, less than 6 months of evolution, adhesive capsulitis are randomly attributed to the control or study group. Both groups receive a series of 3 suprascapular nerve blocks under ultrasound guidance with either 5ml saline or 5ml ropivacaine 2mg/ml ( ref) at 1 week interval. Testing consists of glenohumeral range of motion (ROM) (anterior elevation, lateral elevation, external and internal rotation) measured by goniometer, Constant score and visual analog scale (VAS) pain score. Evaluations are done immediately before and one hour after every suprascapular block and at 4 weeks after the third suprascapular block. All suprascapular nerve blocks are performed by one physician and the evaluations are done by a occupational therapist or MD experienced in glenohumeral function evaluations. All practitioners are blinded to the assigned group. All patients continue their pre-study treatment of physiotherapy and per os pain medication. Patients keep a record of analgesics and NSAID use during the trial. Drop-out rate is measured.

Detailed description

Introduction: Adhesive capsulitis is a painful and debilitating condition affecting adult shoulders. Although relatively rare the condition is more common in diabetic patients and effective pain diminishing treatments without the use of corticosteroids are needed. Methods and Material: Patients presenting with subacute, less than 6 months of evolution, adhesive capsulitis are randomly attributed to the control or study group. Both groups receive a series of 3 successive suprascapular nerve blocks under live ultrasound guidance with either 5ml saline or 5ml ropivacaine 2mg/ml conducted at 1 week interval. Testing consists of glenohumeral ROM (anterior elevation, lateral elevation, external and internal rotation) measured by goniometer, Constant score, VAS pain score. Evaluations are done immediately before and one hour after every "suprascapular block" and at 4 weeks after the third suprascapular block. All suprascapular blocks are performed by one physician and the evaluations by either a occupational therapist or MD experienced in glenohumeral function evaluations. All practitioners are blinded to the assigned group. All patients continue their physiotherapy, consisting of electrotherapy, range of motion, stretching and strengthening exercises and their per os medication. Patients keep record of analgesics and NSAID use during the trial. Drop-out rate is measured during the entire study protocol.

Conditions

• Adhesive Capsulitis
• Frozen Shoulder
• Nerve Block

Interventions

Type	Name	Description
DRUG	Ropivacaine Monohydrochloride	Suprascapular nerve block under ultrasound control: injection of 5ml Ropivacaine HCL 2mg /ml
DRUG	Placebo - Concentrate	Placebo suprascapular nerve block under ultrasound control: injection of 5ml physiological / isotonic saline

Timeline

• Start date: 2016-11-01
• Primary completion: 2020-09-16
• Completion: 2020-09-30
• First posted: 2016-10-26
• Last updated: 2020-10-27

Locations

1 site across 1 country: Belgium