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

NCT02944526 | Completed Phase 4

• 1 other identifier: 2016-10/02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis; Frozen Shoulder; Nerve Block

Keywords

suprascapular nerve

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• change in gleno-humeral joint range of motion (ROM)

  at 0,1,2, and 6 weeks

Study Arms (2)

Ropivacaine Suprascapular Nerve Block

EXPERIMENTAL

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

Placebo Suprascapular Nerve Block

PLACEBO COMPARATOR

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

Interventions

Ropivacaine Monohydrochloride DRUG

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

Ropivacaine Suprascapular Nerve Block

Placebo - Concentrate DRUG

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

Placebo Suprascapular Nerve Block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subacute adhesive capsulitis: pain evolving for less than 6 months before enrollment

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Saint-Jean, Bruxelles: lead
• University Hospital St Luc, Brussels: collaborator

Study Sites (1)

Marc Schiltz, MD

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Bursitis

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• SCHILTZ Marc, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Marc Schiltz MD, Head of Department Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 26, 2016
• Study Start: November 1, 2016
• Primary Completion: September 16, 2020
• Study Completion: September 30, 2020
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)