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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

Tracking Information
First Submitted Date  ICMJE October 24, 2016
First Posted Date  ICMJE October 26, 2016
Last Update Posted Date February 21, 2018
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
  • 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
  • change of pain intensity score [ Time Frame: at 0,1,2 and 6 weeks ]
    pain intensity measured by visual analog scale (VAS)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02944526 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of 3 Ropivacaine Suprascapular Nerve Blocks in Subacute Adhesive Capsulitis: a Randomized Controlled Trial
Official Title  ICMJE The Effect of 3 Ropivacaine Suprascapular Nerve Blocks in Subacute Adhesive Capsulitis: a Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Adhesive Capsulitis
  • Frozen Shoulder
  • Nerve Block
Intervention  ICMJE
  • Drug: Ropivacaine Monohydrochloride
    Suprascapular nerve block under ultrasound control: injection of 5ml Ropivacaine HCL 2mg /ml
  • Drug: Placebo - Concentrate
    Placebo suprascapular nerve block under ultrasound control: injection of 5ml physiological / isotonic saline
Study Arms  ICMJE
  • 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.

    Intervention: Drug: Ropivacaine Monohydrochloride
  • 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.

    Intervention: Drug: Placebo - Concentrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 24, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: SCHILTZ Marc, MD +322259051 mschiltz@clstjean.be
Contact: GILLARD Bruno, MD +322219780 bgillard@clstjean.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02944526
Other Study ID Numbers  ICMJE 2016-10/02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marc Schiltz, Clinique Saint-Jean, Bruxelles
Study Sponsor  ICMJE Clinique Saint-Jean, Bruxelles
Collaborators  ICMJE University Hospital St Luc, Brussels
Investigators  ICMJE
Principal Investigator: SCHILTZ Marc, MD Clinique Saint-Jean
PRS Account Clinique Saint-Jean, Bruxelles
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP