The Effect of 3 Ropivacaine Suprascapular Nerve Blocks in Subacute Adhesive Capsulitis: a Randomized Controlled Trial
Primary Purpose
Adhesive Capsulitis, Frozen Shoulder, Nerve Block
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Ropivacaine Monohydrochloride
Placebo - Concentrate
Sponsored by
About this trial
This is an interventional treatment trial for Adhesive Capsulitis focused on measuring suprascapular nerve
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
Sites / Locations
- Marc Schiltz, MD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ropivacaine Suprascapular Nerve Block
Placebo Suprascapular Nerve Block
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
change of pain intensity score
pain intensity measured by visual analog scale (VAS)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02944526
First Posted
October 24, 2016
Last Updated
October 26, 2020
Sponsor
Clinique Saint-Jean, Bruxelles
Collaborators
University Hospital St Luc, Brussels
1. Study Identification
Unique Protocol Identification Number
NCT02944526
Brief Title
The Effect of 3 Ropivacaine Suprascapular Nerve Blocks in Subacute Adhesive Capsulitis: a Randomized Controlled Trial
Official Title
The Effect of 3 Ropivacaine Suprascapular Nerve Blocks in Subacute Adhesive Capsulitis: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
September 16, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinique Saint-Jean, Bruxelles
Collaborators
University Hospital St Luc, Brussels
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis, Frozen Shoulder, Nerve Block
Keywords
suprascapular nerve
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ropivacaine Suprascapular Nerve Block
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Suprascapular Nerve Block
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Monohydrochloride
Intervention Description
Suprascapular nerve block under ultrasound control: injection of 5ml Ropivacaine HCL 2mg /ml
Intervention Type
Drug
Intervention Name(s)
Placebo - Concentrate
Intervention Description
Placebo suprascapular nerve block under ultrasound control: injection of 5ml physiological / isotonic saline
Primary Outcome Measure Information:
Title
change in constant shoulder score
Description
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
Time Frame
at 0, 1, 2, and 6 weeks
Title
change of pain intensity score
Description
pain intensity measured by visual analog scale (VAS)
Time Frame
at 0,1,2 and 6 weeks
Secondary Outcome Measure Information:
Title
change in gleno-humeral joint range of motion (ROM)
Description
Shoulder flexion, abduction, external rotation and internal rotation measured with goniometer with the patient in standing position
Time Frame
at 0,1,2, and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SCHILTZ Marc, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marc Schiltz, MD
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of 3 Ropivacaine Suprascapular Nerve Blocks in Subacute Adhesive Capsulitis: a Randomized Controlled Trial
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