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

Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02944526
• Other study ID #: 2016-10/02
• Status: Completed
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: Clinique Saint-Jean, Bruxelles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 30, 2020
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• subacute adhesive capsulitis: pain evolving for less than 6 months before enrollment

Exclusion Criteria:

• other conditions involving the shoulder ( rheumatoid or septic arthritis, Hill-Sachs lesions,osteoarthritis of the shoulder, or malignancies in the shoulder region);

• neurologic deficits affecting shoulder function in normal daily activities (such as history of stroke, multiple sclerosis, parkinson disease...)

• shoulder pain caused by cervical radiculopathy

• a history of drug allergy to ropivacaïne

• pregnancy or lactation

• cognitive impairment with inability to fill out a protocol

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis
• Frozen Shoulder
• Nerve Block

Intervention

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

Locations

Country	Name	City	State
Belgium	Marc Schiltz, MD	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Clinique Saint-Jean, Bruxelles	University Hospital St Luc, Brussels

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in constant shoulder score	the total constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain, activity of daily living, ROM and strength	at 0, 1, 2, and 6 weeks
Primary	change of pain intensity score	pain intensity measured by visual analog scale (VAS)	at 0,1,2 and 6 weeks
Secondary	change in gleno-humeral joint range of motion (ROM)	Shoulder flexion, abduction, external rotation and internal rotation measured with goniometer with the patient in standing position	at 0,1,2, and 6 weeks