MedTrace Logo

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

NCT02944526 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-10-27

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University Hospital St Luc, Brussels

    collaborator OTHER

  • Clinique Saint-Jean, Bruxelles

    lead OTHER

Principal Investigators

  • SCHILTZ Marc, MD · Universitair Ziekenhuis Brussel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2020-09-16
Completion
2020-09-30

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02944526 on ClinicalTrials.gov