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

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ClinicalTrials.gov Identifier: NCT02944526
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : February 21, 2018
Sponsor:
Collaborator:
University Hospital St Luc, Brussels
Information provided by (Responsible Party):
Marc Schiltz, Clinique Saint-Jean, Bruxelles

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.


Condition or disease Intervention/treatment Phase
Adhesive Capsulitis Frozen Shoulder Nerve Block Drug: Ropivacaine Monohydrochloride Drug: Placebo - Concentrate Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of 3 Ropivacaine Suprascapular Nerve Blocks in Subacute Adhesive Capsulitis: a Randomized Controlled Trial
Study Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. change in constant shoulder score [ Time Frame: at 0, 1, 2, and 6 weeks ]
    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

  2. change of pain intensity score [ Time Frame: at 0,1,2 and 6 weeks ]
    pain intensity measured by visual analog scale (VAS)


Secondary Outcome Measures :
  1. change in gleno-humeral joint range of motion (ROM) [ Time Frame: at 0,1,2, and 6 weeks ]
    Shoulder flexion, abduction, external rotation and internal rotation measured with goniometer with the patient in standing position



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944526


Contacts
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Contact: SCHILTZ Marc, MD +322259051 mschiltz@clstjean.be
Contact: GILLARD Bruno, MD +322219780 bgillard@clstjean.be

Locations
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Belgium
Clinique Saint-Jean Recruiting
Brussels, Belgium, 1000
Contact: Marc Schiltz, MD    +322259051    mschiltz@clstjean.be   
Contact: Tom De Baere, MD    +322219897    tdebaere@clstjean.be   
Sponsors and Collaborators
Clinique Saint-Jean, Bruxelles
University Hospital St Luc, Brussels
Investigators
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Principal Investigator: SCHILTZ Marc, MD Clinique Saint-Jean

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Responsible Party: Marc Schiltz, Dr Marc Schiltz MD, Head of Department Physical Medicine and Rehabilitation, Clinique Saint-Jean, Bruxelles
ClinicalTrials.gov Identifier: NCT02944526     History of Changes
Other Study ID Numbers: 2016-10/02
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marc Schiltz, Clinique Saint-Jean, Bruxelles:
suprascapular nerve

Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents