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

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.

Study Overview

• Status: Completed
• Conditions: Adhesive Capsulitis; Nerve Block; Frozen Shoulder
• Intervention / Treatment: Drug: Ropivacaine Monohydrochloride; Drug: Placebo - Concentrate

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Marc Schiltz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ropivacaine Suprascapular Nerve Block; Suprascapular nerve block realized in sterile conditions under live ultrasound guidance: injection of 5ml of Ropivacaine monohydrochloride 2mg/ml. 3 successive blocks are realized at 1 week interval.	Drug: Ropivacaine Monohydrochloride; Suprascapular nerve block under ultrasound control: injection of 5ml Ropivacaine HCL 2mg /ml
Placebo Comparator: Placebo Suprascapular Nerve Block; Suprascapular nerve block realized in sterile conditions under live ultrasound guidance: injection of 5ml of physiological /isotonic saline. 3 successive blocks are realized at 1 week interval.	Drug: Placebo - Concentrate; Placebo suprascapular nerve block under ultrasound control: injection of 5ml physiological / isotonic saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
change of pain intensity score	pain intensity measured by visual analog scale (VAS)	at 0,1,2 and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Clinique Saint-Jean, Bruxelles
• Collaborators: University Hospital St Luc, Brussels
• Investigators: Principal Investigator: SCHILTZ Marc, MD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): September 16, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: suprascapular nerve
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2016-10/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No