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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adhesive Capsulitis, Frozen Shoulder, Nerve Block

Intervention / Treatment
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* Drug: Ropivacaine Monohydrochloride
* Drug: Placebo - Concentrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine Suprascapular Nerve Block<br>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<br>* Suprascapular nerve block under ultrasound control: injection of 5ml Ropivacaine HCL 2mg /ml<br>|
| Placebo Comparator: Placebo Suprascapular Nerve Block<br>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<br>* Placebo suprascapular nerve block under ultrasound control: injection of 5ml physiological / isotonic saline<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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suprascapular nerve