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OpenTrials
Completed

NCT Number: NCT02944526

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Marc Schiltz, MD

Brussels, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine Monohydrochloride

Drug

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

Placebo - Concentrate

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Clinique Saint-Jean, Bruxelles

Other

Collaborators

  • University Hospital St Luc, Brussels

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 26, 2016
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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