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

NCT ID: NCT02944526

Last Updated: 2020-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2020-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ropivacaine Monohydrochloride

Intervention Type: DRUG

Suprascapular nerve block under ultrasound control: injection of 5ml Ropivacaine HCL 2mg /ml

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.

Group Type: PLACEBO_COMPARATOR

Placebo - Concentrate

Intervention Type: DRUG

Placebo suprascapular nerve block under ultrasound control: injection of 5ml physiological / isotonic saline

Interventions

Ropivacaine Monohydrochloride

Suprascapular nerve block under ultrasound control: injection of 5ml Ropivacaine HCL 2mg /ml

Intervention Type: DRUG

Placebo - Concentrate

Placebo suprascapular nerve block under ultrasound control: injection of 5ml physiological / isotonic saline

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital St Luc, Brussels

OTHER

Sponsor Role: collaborator

Clinique Saint-Jean, Bruxelles

OTHER

Sponsor Role: lead

Responsible Party

Marc Schiltz, MD

Dr Marc Schiltz MD, Head of Department Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SCHILTZ Marc, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

Marc Schiltz, MD

Brussels, , Belgium

Countries

Belgium

Other Identifiers

2016-10/02

Identifier Type: -

Identifier Source: org_study_id